• Findings from the Phase 1b RAMP study evaluating the combination of Rubraca and Xtandi® (enzalutamide) in men with unselected mCRPC lay the groundwork for the Phase 3 CASPAR study which is expected to begin enrolling patients shortly
    • Phase 1 data from the RUCA-J study of Rubraca in Japanese patients with advanced solid tumors show similar safety and pharmacokinetic profiles to those observed in Western patients

     

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced that Phase 1 clinical data from studies exploring Rubraca in combination with Xtandi for the treatment of advanced prostate cancer (RAMP) and Rubraca monotherapy in advanced solid tumors in Japanese patients (RUCA-J) will be presented during week one of the American Association for…

    • Findings from the Phase 1b RAMP study evaluating the combination of Rubraca and Xtandi® (enzalutamide) in men with unselected mCRPC lay the groundwork for the Phase 3 CASPAR study which is expected to begin enrolling patients shortly
    • Phase 1 data from the RUCA-J study of Rubraca in Japanese patients with advanced solid tumors show similar safety and pharmacokinetic profiles to those observed in Western patients

     

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced that Phase 1 clinical data from studies exploring Rubraca in combination with Xtandi for the treatment of advanced prostate cancer (RAMP) and Rubraca monotherapy in advanced solid tumors in Japanese patients (RUCA-J) will be presented during week one of the American Association for Cancer Research Virtual Annual Meeting (AACR), taking place April 10-15, 2021.

    "We remain committed to understanding how Rubraca may benefit patients with cancer, and the data presented at AACR further enhance our understanding in different patient populations and solid tumor types," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The Phase 1b RAMP data for the combination of Rubraca and Xtandi in unselected mCRPC patients help inform the Alliance for Clinical Oncology-sponsored CASPAR Phase 3 trial which is expected to begin enrolling patients soon, and we look forward to learning more about the combination."

    Following are details of the Clovis-sponsored presentations at AACR 2021:

    Poster Presentation 445: Genomic Characteristics and Response to Rucaparib and Enzalutamide in the Phase 1b RAMP Study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients

    • Lead author: Arpit Rao, MBBS, University of Minnesota, Minneapolis, USA
    • Session: Clinical Research
    • Date/Time: April 10, 2021, 8:30 a.m. - 11:59 p.m. ET
    • Key Takeaways: The results of this study demonstrated that unselected patients with mCRPC who had progressed on androgen receptor (AR)-directed therapies reported declines in prostate-specific antigen (PSA) following treatment with a combination of rucaparib 600 mg twice daily and enzalutamide 160 mg once daily, and these declines were observed even in the presence of AR alterations and the absence of DNA damage repair gene alterations. The safety profile was consistent with that associated with each drug as a monotherapy, with no clinically significant drug-drug interactions observed with the combination. These data support further study of the combination in this patient population and the Phase 3 CASPAR study (Alliance A031902; NCT04455750) is expected to begin enrolling biomarker-unselected patients with mCRPC shortly.

    Poster Presentation CT124: Evaluation of Rucaparib in Japanese Patients with a Previously Treated Advanced Solid Tumor

    • Lead author: Kenji Tamura, MD, PhD, National Cancer Center Hospital, Tokyo, Japan
    • Session: Phase I Clinical Trials
    • Date/Time: April 10, 2021, 8:30 a.m. - 11:59 p.m. ET
    • Key Takeaways: This study suggests rucaparib 600 mg taken twice daily had a manageable safety profile for Japanese patients with advanced solid tumors, including ovarian, prostate, endometrial, and pancreatic cancer. The pharmacokinetic profile of rucaparib in Japanese patients overlapped with that of Western patients. Among patients with measurable disease, 18.5% (5/27) achieved an objective response rate and 51.9% (14/27) had stable disease per RECIST v1.1. These results support further exploration of rucaparib 600 mg twice daily in Japanese patients.

    The presentations can also be viewed at https://www.clovisoncology.com/pipeline/scientificpresentations/ .

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

    Rubraca U.S. FDA Approved Indications

    Ovarian Cancer

    Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

    Rubraca is indicated for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

    Prostate Cancer

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Patients should be identified for treatment with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. For males on Rubraca treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

    Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

    Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

    Please click here for full Prescribing Information for Rubraca.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    About CASPAR Clinical Trial

    The CASPAR study is sponsored by the Alliance for Clinical Trials in Oncology (Alliance A031902; NCT04455750) and will enroll approximately 1,000 patients in the United States. It is expected to open at hundreds of National Clinical Trials Network (NCTN) sites nationally. This is the only combination trial of a PARP inhibitor and novel anti-androgen with an overall survival co-primary endpoint. Patients who have received prior abiraterone/apalutamide in a non-mCRPC setting are allowed to enroll to maximize applicability in the era of rapidly changing standards-of-care. The Alliance is part of the NCTN sponsored by the National Cancer Institute (NCI).

    About Alliance for Clinical Trials in Oncology

    The Alliance for Clinical Trials in Oncology develops and conducts clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as research methods to alleviate side effects of cancer and cancer treatments. The Alliance is part of the National Clinical Trials Network (NCTN) sponsored by the National Cancer Institute (NCI) and serves as a research base for the NCI Community Research Oncology Program (NCORP). The Alliance comprises nearly 10,000 cancer specialists at hospitals, medical centers, and community clinics across the United States and Canada. Learn more about the Alliance, visit www.AllianceforClinicalTrialsinOncology.org.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding the potential results of such clinical trials, our expectations regarding the suitability of Rubraca for certain patient populations or indications, and our plans to develop Rubraca in additional indications and tumor types, and our expectations regarding the outcomes of early studies or trials supporting further development, both non-clinical and clinical. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates and those of our partners, whether future study results will be consistent with study findings to date, the timing of availability of data from our clinical trials and the initiation, enrollment, timing and results of our planned clinical trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, the risk that additional pre-clinical or clinical studies may not support further development in certain additional indications or tumor types, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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    • Data from the randomized, Phase 3 ARIEL4 study to be presented today at the Society of Gynecologic Oncology Virtual Annual Meeting on Women's Cancer
    • The ARIEL4 study met its primary endpoint, showing a statistically significant improvement in investigator-assessed progression-free survival (PFS) for Rubraca versus chemotherapy
    • The safety of Rubraca observed in the ARIEL4 study was highly consistent with both the U.S. and EU product labels

     

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced that the first presentation of data from the randomized, Phase 3 ARIEL4 study of Rubraca® (rucaparib) will take place today in an oral presentation at the Society of Gynecologic Oncology Virtual Annual Meeting on Women's Cancer (SGO). The data demonstrate…

    • Data from the randomized, Phase 3 ARIEL4 study to be presented today at the Society of Gynecologic Oncology Virtual Annual Meeting on Women's Cancer
    • The ARIEL4 study met its primary endpoint, showing a statistically significant improvement in investigator-assessed progression-free survival (PFS) for Rubraca versus chemotherapy
    • The safety of Rubraca observed in the ARIEL4 study was highly consistent with both the U.S. and EU product labels

     

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced that the first presentation of data from the randomized, Phase 3 ARIEL4 study of Rubraca® (rucaparib) will take place today in an oral presentation at the Society of Gynecologic Oncology Virtual Annual Meeting on Women's Cancer (SGO). The data demonstrate that Rubraca significantly improves PFS compared to standard-of-care chemotherapy, including platinum-based chemotherapy, among patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation who have received two or more prior lines of chemotherapy.

    "Data from the ARIEL4 study meaningfully enhance our understanding about the role of Rubraca among women with BRCA mutation-positive relapsed ovarian cancer, as well as the clinical relevance of BRCA reversion mutations," said Dr. Rebecca Kristeleit, Co-Coordinating Investigator of ARIEL4 and Consultant Medical Oncologist, Guy's and St Thomas' NHS Foundation Trust, London, UK. "This is important because women with more advanced disease have fewer treatment options, and it is increasingly important to understand how specific mutations affect treatment outcomes."

    Dr. Kristeleit will present "Rucaparib versus chemotherapy in patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation: efficacy and safety from ARIEL4, a randomized phase 3 study" today during the SGO Scientific Plenary I: Innovation and Progress in Gynecologic Oncology session from 2:35 pm - 3:45 pm CT. The presentation can also be viewed at https://www.clovisoncology.com/pipeline/scientific-presentations/ starting today at 2:35 pm CT.

    The ARIEL4 study (NCT02855944) is a Phase 3 multicenter, randomized study evaluating Rubraca versus chemotherapy in fully platinum-sensitive, partially platinum-sensitive and platinum-resistant patients with relapsed ovarian cancer and a BRCA mutation (inclusive of germline and/or somatic) who have received two or more prior lines of chemotherapy. The primary endpoint of the study is investigator-assessed PFS, with a step-down analysis from the primary efficacy population (if significant) to the intent-to-treat (ITT) population.

    The study enrolled 349 women in Europe, Israel and North and South America. The primary efficacy population (n=325) comprised the group of patients with a deleterious tumor BRCA mutation and excluded those with a BRCA reversion mutation as determined by a blood test. The rucaparib arm in this population (n=220) achieved statistical significance over the chemotherapy arm (n=105) for the primary endpoint of PFS with a hazard ratio of 0.64 (p=0.001). The median PFS for the patients in the efficacy population treated with rucaparib was 7.4 months versus 5.7 months among those who received chemotherapy.

    Additionally, in the ITT population (n=349), the rucaparib arm (n=233) achieved statistical significance over the chemotherapy arm (n=116) for the primary endpoint of PFS with a hazard ratio of 0.67 (p=0.002). The median PFS for the patients in the ITT population treated with rucaparib was 7.4 months versus 5.7 months among those who received chemotherapy.

    Adverse events were consistent with the known safety profiles of Rubraca and chemotherapy. The most common (>5%) treatment-emergent ≥grade 3 adverse events (TEAEs) among all patients treated with rucaparib (n=232) in the ARIEL4 study were anemia/decreased hemoglobin (22%), neutropenia/decreased absolute neutrophil count (10%), asthenia/fatigue (8%), thrombocytopenia/decreased platelets (8%), and increased ALT/AST (8%).

    "The ARIEL4 data add to the growing scientific understanding about the clinical utilization of Rubraca compared to chemotherapy, including platinum-based chemotherapy, for women diagnosed with BRCA mutation-positive advanced ovarian cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We remain committed to expanding treatment options for patients living with cancer and are pleased to share these data with physicians and their patients to help improve outcomes for women with ovarian cancer."

    According to the American Cancer Society, an estimated more than 21,000 women will be diagnosed with ovarian cancer in the United States and there will be an estimated nearly 14,000 deaths from ovarian cancer in 2021, and according to GLOBOCAN in 2020, an estimated 66,000 women in Europe are diagnosed each year with ovarian cancer, and ovarian cancer is among those cancers with the highest rate of deaths. According to the American Cancer Society, more than 75% of women are diagnosed with ovarian cancer at an advanced stage, and patients who are diagnosed with advanced ovarian cancer have a 70-95% chance of recurrence according to the Ovarian Cancer Research Alliance.

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

    Rubraca Ovarian Cancer U.S. FDA Approved Indications

    Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

    Rubraca is indicated for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) have occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.

    Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

    Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

    Click here or full Prescribing Information and additional Important Safety Information.

    Rubraca (rucaparib) European Union (EU) authorized use and Important Safety Information

    Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

    Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with ≥2 prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

    Efficacy of Rubraca as treatment for relapsed or progressive epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) has not been investigated in patients who have received prior treatment with a PARP inhibitor. Therefore, use in this patient population is not recommended.

    Summary warnings and precautions:

    Hematological toxicity

    During treatment with Rubraca, events of myelosuppression (anemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8–10 weeks of treatment with Rubraca. These reactions are manageable with routine medical treatment and/or dose adjustment for more severe cases. Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised. Patients should not start Rubraca treatment until they have recovered from hematological toxicities caused by previous chemotherapy (CTCAE grade ≥1).

    Supportive care and institutional guidelines should be implemented for the management of low blood counts for the treatment of anemia and neutropenia. Rubraca should be interrupted or dose reduced according to Table 1 (see Posology and Method of Administration [4.2] of the Summary of Product Characteristics [SPC]) and blood counts monitored weekly until recovery. If the levels have not recovered to CTCAE grade 1 or better after 4 weeks, the patient should be referred to a hematologist for further investigations.

    MDS/AML

    MDS/AML, including cases with fatal outcome, have been reported in patients who received Rubraca. The duration of therapy with Rubraca in patients who developed MDS/AML varied from less than 1 month to approximately 28 months.

    If MDS/AML is suspected, the patient should be referred to a hematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics. If, following investigation for prolonged hematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.

    Photosensitivity

    Photosensitivity has been observed in patients treated with Rubraca. Patients should avoid spending time in direct sunlight because they may burn more easily during Rubraca treatment; when outdoors, patients should wear a hat and protective clothing, and use sunscreen and lip balm with sun protection factor of 50 or greater.

    Gastrointestinal toxicities

    Gastrointestinal toxicities (nausea and vomiting) are frequently reported with Rubraca, and are generally low grade (CTCAE grade 1 or 2), and may be managed with dose reduction (refer to Posology and Method of Administration [4.2], Table 1 of the SPC) or interruption. Antiemetics, such as 5-HT3 antagonists, dexamethasone, aprepitant and fosaprepitant, can be used as treatment for nausea/vomiting and may also be considered for prophylactic (i.e. preventative) use prior to starting Rubraca. It is important to proactively manage these events to avoid prolonged or more severe events of nausea/vomiting which have the potential to lead to complications such as dehydration or hospitalization.

    Embryofetal toxicity

    Rubraca can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. In an animal reproduction study, administration of Rubraca to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see Preclinical Safety Data [5.3] of the SPC).

    Pregnancy/contraception

    Pregnant women should be informed of the potential risk to a fetus. Women of reproductive potential should be advised to use effective contraception during treatment and for 6 months following the last dose of Rubraca (see section 4.6 of the SPC). A pregnancy test before initiating treatment is recommended in women of reproductive potential.

    Click here to access the current SPC. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding the potential results of such clinical trials, our expectations regarding the suitability of Rubraca for certain patient populations or indications, and our plans to develop Rubraca in additional indications and tumor types, and our expectations regarding the outcomes of early studies or trials supporting further development, both non-clinical and clinical. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates and those of our partners, whether future study results will be consistent with study findings to date, the timing of availability of data from our clinical trials and the initiation, enrollment, timing and results of our planned clinical trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, the risk that additional pre-clinical or clinical studies may not support further development in certain additional indications or tumor types, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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    • $164.5M in Rubraca® (rucaparib) global net product revenues for 2020, up 15% over 2019; $43.3M in Rubracaglobal net product revenues for Q4 2020, up 10% over Q4 2019
    • Phase 1/2 LuMIERE study of FAP-2286, a targeted radiotherapy, planned to begin 1H 2021
    • Top-line data from Phase 3 ATHENA trial of Rubraca as first-line maintenance ovarian cancer monotherapy anticipated 2H 2021
    • Interim data from Phase 2 cohorts of LIO-1 study of lucitanib in combination with Opdivo® (nivolumab) in gynecologic cancers anticipated at 2021 medical meetings
    • Net cash used in operating activities significantly lower in 2020 compared to 2019
    • $240.2M in cash and cash equivalents at December 31, 2020, which is anticipated to fund the Company's operating plan into
    • $164.5M in Rubraca® (rucaparib) global net product revenues for 2020, up 15% over 2019; $43.3M in Rubraca global net product revenues for Q4 2020, up 10% over Q4 2019
    • Phase 1/2 LuMIERE study of FAP-2286, a targeted radiotherapy, planned to begin 1H 2021
    • Top-line data from Phase 3 ATHENA trial of Rubraca as first-line maintenance ovarian cancer monotherapy anticipated 2H 2021
    • Interim data from Phase 2 cohorts of LIO-1 study of lucitanib in combination with Opdivo® (nivolumab) in gynecologic cancers anticipated at 2021 medical meetings
    • Net cash used in operating activities significantly lower in 2020 compared to 2019
    • $240.2M in cash and cash equivalents at December 31, 2020, which is anticipated to fund the Company's operating plan into early 2023 based on current revenue and expense forecasts

     

    Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter and year ended December 31, 2020, and provided an update on the Company's clinical development programs and regulatory and commercial outlook for 2021.

    "Despite the evident COVID-related challenges of 2020, we are pleased with our overall sales performance and pipeline progress," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Most importantly, we advanced our development programs in 2020, positioning them for important potential achievements in 2021, including the initiation of clinical development for FAP-2286 in the first half of the year, top-line ATHENA monotherapy data in the second half of the year and initial efficacy data for the LIO-1 lucitanib and Opdivo combination trial at medical meetings later this year. While early, we are increasingly enthusiastic about FAP-2286 and our commitment to becoming a leader in the emerging field of targeted radionuclide therapy."

    Fourth Quarter and Year-End 2020 Financial Results

    Clovis reported global net product revenues for Rubraca of $43.3 million for the fourth quarter of 2020, which included U.S. product revenues of $36.4 million and ex-U.S. product revenues of $6.9 million, respectively. This represents a 10 percent increase year-over-year compared to Q4 2019 net product revenues of $39.3 million, which included U.S. net product revenues of $36.1 million and ex-U.S. net product revenues of $3.2 million.

    Rubraca global net product revenues for 2020 were $164.5 million, which included $146.3 million in the U.S. and $18.2 million in ex-U.S. product revenues, respectively. This represents a 15 percent increase year-over-year compared to 2020 net product revenues of $143.0 million, which included $137.2 million in the U.S. and ex-U.S. net product revenues of $5.8 million.

    Research and development expenses totaled $56.7 million for Q4 2020 and $257.7 million for FY 2020, down 22 percent and 9 percent, respectively, compared to $72.5 million and $283.1 million for the comparable periods in 2019. Research and development expenses decreased for the quarter and year compared to the same periods in the prior year due primarily to lower spending on Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to 2020.

    Selling, general and administrative expenses totaled $40.8 million for Q4 2020 and $163.9 million for FY 2020, both down 10 percent compared to $45.2 million and $182.8 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the quarter and year compared to the same periods in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts. We expect selling, general and administrative expenses to decrease in the full year 2021 compared to 2020.

    Clovis reported a net loss for the fourth quarter of 2020 of $99.0 million, or ($1.02) per share, and a net loss of $369.2 million, or ($4.38) per share, for FY 2020. Net loss for Q4 2019 was $99.5 million, or ($1.81) per share, and $400.4 million, or a net loss of ($7.43) per share, for FY 2019. Net loss for Q4 and FY 2020 included share-based compensation expense of $12.0 million and $50.8 million, compared to $12.6 million and $54.3 million for the comparable periods of 2019.

    Clovis had $240.2 million in cash and cash equivalents as of December 31, 2020, which is expected to fund the Company's operating plan into early 2023 based on current revenue and expense forecasts.

    As of December 31, 2020, the Company had drawn approximately $100 million under the Sixth Street Partners, LLC ATHENA clinical trial financing and had up to $75 million available to draw under the agreement to fund the expenses of the ATHENA trial.

    Net cash used in operating activities was $56.1 million for the fourth quarter of 2020, down from $70.1 million reported in the fourth quarter of 2019. Similarly, net cash used in operating activities for FY 2020 was $252.7 million, compared with $323.6 million for FY 2019. Cash burn in Q4 2020 was $40.9 million, down 27 percent from the Q4 2019 quarter cash burn of $56.3 million. Cash burn for the twelve months ended December 31, 2020 was $195.6M million, down 36 percent from the twelve months ended 2019 cash burn of $304.7 million. We expect this trend of lower cash burn to continue in 2021.

    Clovis Oncology Pipeline Highlights

    Rubraca ARIEL4 Study Met Primary Endpoint of Improved PFS Compared to Chemotherapy

    In December, Clovis announced the top line results of the ARIEL4 randomized Phase 3 study of Rubraca versus standard-of-care chemotherapy, in which Rubraca met the primary endpoint of significantly improving progression-free survival (PFS) in later-line ovarian cancer patients with a BRCA mutation. The safety observed in the study was highly consistent with both the U.S. and European labels. These results were submitted as a late-breaking abstract and accepted as an oral presentation at the upcoming Society for Gynecologic Oncology Virtual Annual Meeting in March. Completion of ARIEL4 is a post-marketing commitment in the U.S. and Europe.

    Anticipated Rubraca Pipeline Events in 2021

    Top-line data from the ATHENA Phase 3 study in first-line maintenance treatment ovarian cancer setting evaluating Rubraca monotherapy versus placebo are expected in the second-half of 2021, contingent on achieving sufficient PFS events. Data from the combination arm of Rubraca plus Opdivo versus Rubraca monotherapy are expected a year or more later.

    LODESTAR, the Company's Phase 2 trial of Rubraca in patients with solid tumors with deleterious mutations in homologous recombination repair (HRR) genes is currently enrolling. This study may be registration-enabling with a potential regulatory filing by the end of 2021 or first-half 2022.

    LuMIERE Phase 1/2 Study of FAP-2286 Expected to Begin 1H 2021

    FAP-2286 is Clovis Oncology's peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) and represents its lead candidate in the PTRT development program. Clovis intends to initiate the Phase 1/2 LuMIERE clinical study of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286) to determine the dose and tolerability of the FAP-targeting therapeutic agent (Phase 1), with expansion cohorts planned in multiple tumor types (Phase 2). FAP-2286 labelled with gallium-68 (68Ga-FAP-2286) will be utilized as a diagnostic to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. The LuMIERE study is expected to begin in the first half of 2021, pending acceptance by the FDA of gallium-68 CMC data from clinical sites. Other studies of FAP-2286 linked to an alpha-particle emitting radionuclide and combination studies are also being planned.

    Interim LIO-1 data of Lucitanib and Opdivo in Combination Expected in 2021

    The Phase 2 part of the LIO-1 study of lucitanib in combination with Opdivo continues to enroll patients with gynecologic cancers, and Clovis Oncology intends to present initial data at 2021 medical meetings, which are expected to include interim results from the ovarian and endometrial cancer expansion cohorts.

    Conference Call Details

    Clovis will hold a conference call to discuss Q4/FY 2020 results this morning, February 23, at 8:30am ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 5869256.

    About Rubraca (rucaparib)

    Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

    In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

    In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

    Rubraca is an unlicensed medical product outside of the U.S. and Europe.

    About Lucitanib

    Lucitanib is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

    Lucitanib is an unlicensed medical product.

    About FAP-2286

    FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two parts; a peptide that binds to FAP and a linker and site that can be used to attach radiation for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

    FAP-2286 is an unlicensed medical product.

    About Peptide-Targeted Radionuclide Therapy

    Peptide-targeted radionuclide therapy (PTRT) is a form of targeted radiotherapy that is emerging as a new treatment option for patients with cancer. These therapies consist of a small amount of a radioactive isotope, known as a radionuclide, linked to a cell-targeting peptide that binds to a cancer specific protein which selectively directs the radionuclide to tumors. Following binding, the radionuclide warhead emits ionizing radiation causing DNA damage and cell death to neighboring tumor cells.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing innovative anti-cancer agents in the U.S., Europe, and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our future financial and operating performance, business plans or prospects, our expectations regarding the impact of COVID-19 on our business operations and results, including future revenues, supply and distribution of our clinical trial supplies and commercial product supplies, our expectations regarding our ability to maintain the enrollment and conduct of our clinical trials and other development activities, expectations concerning future regulatory activities, expectations for submission of regulatory filings, our plans to present final or interim data on ongoing clinical trials, our plans to submit additional data to, or meet with, the FDA with respect to the status of or plans for ongoing or planned trials, the timing and pace of commencement of enrollment in and conduct of our clinical trials and the cost of certain trials, including those being considered, planned or conducted in collaboration with partners, our plans for commencement of additional planned trials, the potential results of such clinical trials, changes in drug supply timing and costs and other expenses and statements regarding our expectations of the supply of free drug distributed to eligible patients and our expectations regarding the funding that may be available to us under the agreement with Sixth Street Partners, LLC. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance, or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the impacts of the COVID-19 pandemic and disruption related to efforts to mitigate its spread on our business, results of operations or financial condition, including impacts on the vendors or distribution channels in our supply chain, impacts on our contract manufacturers' ability to continue to manufacture our products, impacts on our ability to continue our development activities, impacts on the conduct of our clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites or monitoring of data and impact on the ability and timing of our field personnel to conduct their activities with health care providers, the uncertainties inherent in the effect our future revenues or expenses may have on our cash position, the market potential of our approved drug, including the performance of our sales and marketing efforts and the success of competing drugs and therapeutic approaches, changes in gross-to-net or free drug provided through our patient assistance program, the availability of reimbursement and insurance coverage, the performance of our third-party manufacturers, whether our clinical development programs for our drug candidates and those of our partners can be completed on time or at all, whether future study results will be consistent with study findings to date and whether future study results will support continued development or regulatory approval, the corresponding development pathways of our companion diagnostics, the timing of availability of data from our clinical trials and the results, the initiation, enrollment, timing and results of our planned clinical trials, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to accept or approve drug applications that may be filed, their interpretations of our data and agreement with our regulatory approval strategies or components of our filings, including our clinical trial designs, conduct and methodologies, as well as their decisions regarding drug labeling, reimbursement and pricing, and other matters that could affect the development, approval, availability or commercial potential of our drug candidates or companion diagnostics. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

    CLOVIS ONCOLOGY, INC

    CONSOLIDATED FINANCIAL RESULTS

    (Unaudited, in thousands, except per share amounts)

     

     

     

     

     

     

     

     

    Three Months Ended December 31,

     

     

    Twelve Months Ended December 31,

     

    2020

    2019

     

     

    2020

    2019

    Revenues:  
    Product revenue

    $ 43,299

     

    $ 39,307

     

     

    $ 164,522

     

    $ 143,006

     

       
    Operating expenses:  
    Cost of sales - product

    9,474

     

    7,942

     

     

    36,128

     

    29,926

     

    Cost of sales - intangible asset amortization

    1,342

     

    1,211

     

     

    5,177

     

    4,760

     

    Research and development

    56,706

     

    72,473

     

     

    257,707

     

    283,146

     

    Selling, general and administrative

    40,758

     

    45,168

     

     

    163,894

     

    182,769

     

    Acquired in-process research and development

    -

     

    -

     

     

    -

     

    9,440

     

    Other operating expenses

    -

     

    4,172

     

     

    3,804

     

    9,711

     

    Total expenses

    108,280

     

    130,966

     

     

    466,710

     

    519,752

     

       
    Operating loss

    (64,981

    )

    (91,659

    )

     

    (302,188

    )

    (376,746

    )

       
    Other income (expense):  
    Interest expense

    (7,349

    )

    (6,720

    )

     

    (30,508

    )

    (19,405

    )

    Foreign currency gain (loss)

    30

     

    100

     

     

    (72

    )

    (547

    )

    (Loss) gain on extinguishment of debt

    -

     

    -

     

     

    (3,277

    )

    18,480

     

    Loss on convertible senior notes conversion

    (27,284

    )

    -

     

     

    (35,075

    )

    -

     

    Legal settlement loss

    -

     

    -

     

     

    -

     

    (26,750

    )

    Other income

    202

     

    1,262

     

     

    1,361

     

    6,342

     

    Other income (expense), net

    (34,401

    )

    (5,358

    )

     

    (67,571

    )

    (21,880

    )

       
    Loss before income taxes

    (99,382

    )

    (97,017

    )

     

    (369,759

    )

    (398,626

    )

    Income tax benefit (expense)

    425

     

    (2,484

    )

     

    547

     

    (1,798

    )

    Net loss

    $ (98,957

    )

    $ (99,501

    )

     

    $ (369,212

    )

    $ (400,424

    )

       
    Basic and diluted net loss per common share

    $ (1.02

    )

    $ (1.81

    )

     

    $ (4.38

    )

    $ (7.43

    )

       
    Basic and diluted weighted-average common shares

    96,681

     

    54,834

     

     

    84,307

     

    53,873

     

    CONSOLIDATED BALANCE SHEET DATA
    (Unaudited, in thousands)
       
    December 31, 2020   December 31, 2019
       
    Cash and cash equivalents

    $ 240,229

     

     

    $ 161,833

     

    Available-for-sale securities

    -

     

     

    134,826

     

    Working capital

    125,901

     

     

    233,384

     

    Total assets

    605,554

     

     

    669,604

     

    Convertible senior notes

    499,044

     

     

    644,751

     

    Common stock and additional paid-in capital

    2,498,283

     

     

    2,114,123

     

    Total stockholders' deficit

    (158,748

    )

     

    (174,257

    )

       
    Other Data
    (Unaudited, in thousands)
     

    Twelve Months Ended December 31,

    2020

     

    2019

       
    Net cash used in operating activities

    (252,728

    )

     

    (323,615

    )

       
    Share Based Compensation Expense

    50,794

     

     

    54,304

     

    RECONCILIATION OF NET CASH USED IN OPERATING
    ACTIVITIES TO CASH BURN
    (Unaudited, in thousands)
     

    Three Months Ended December 31,

     

    Twelve Months Ended December 31,

    2020

    2019

     

    2020

    2019

     
    Net cash used in operating activities

    $ (56,053

    )

    $ (70,147

    )

    $ (252,728

    )

    $ (323,615

    )

    Adjustments:
    Acquired in-process research and development - milestone payment

    -

     

    -

     

    (8,000

    )

    (15,750

    )

    Proceeds from borrowings under financing agreement

    15,156

     

    13,828

     

    65,119

     

    34,636

     

    Cash burn

    $ (40,897

    )

    $ (56,319

    )

    $ (195,609

    )

    $ (304,729

    )

     
    Net cash (used in) provided by investing activities

    $ (260

    )

    $ 16,767

     

    $ 126,328

     

    $ 143,398

     

     
    Net cash provided by financing activities

    $ 71,836

     

    $ 13,206

     

    $ 203,644

     

    $ 119,888

     

    To supplement our financial statements prepared in accordance with U. S. GAAP, we monitor and consider cash burn, which is a non-U.S. GAAP financial measure. This non-U.S. GAAP financial measure is not based on any standardized methodology prescribed by U.S. GAAP and is not necessarily comparable to similarly-titled measures presented by other companies. We define cash burn as net cash used in operating activities plus acquired in-process research and development - milestone payments less proceeds from borrowings under financing agreement with Sixth Street specifically related to our Phase 3 ATHENA trial. We believe cash burn to be a liquidity measure that provides useful information to management and investors about the amount of cash consumed by the operations of the business including milestone payments and proceeds from borrowings under the Sixth Street financing agreement, which specifically offsets the costs of our ATHENA trial. A limitation of using this non-U.S. GAAP measure is that cash burn does not represent the total change in cash and cash equivalents for the period because it excludes all other cash provided by or used for other investing and financing activities. We account for this limitation by providing information about our investing and financing activities in the statements of cash flows in our financial statements and by presenting cash flows from investing and financing activities in our reconciliation of cash burn. In addition, it is important to note that other companies, including companies in our industry, may not use cash burn, may calculate cash burn in a different manner than we do or may use other financial measures to evaluate their performance, all of which could reduce the usefulness of cash burn as a comparative measure. Because of these limitations, cash burn should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with U.S. GAAP.

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  1. Clovis Oncology, Inc. (NASDAQ:CLVS) will announce its fourth quarter and year-end 2020 financial results on Tuesday, February 23, 2021, before the open of the U.S. financial markets. Clovis' senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the Company's results in greater detail.

    The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and a replay of the webcast will be available for 30 days.

    Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 5869256.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing…

    Clovis Oncology, Inc. (NASDAQ:CLVS) will announce its fourth quarter and year-end 2020 financial results on Tuesday, February 23, 2021, before the open of the U.S. financial markets. Clovis' senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the Company's results in greater detail.

    The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and a replay of the webcast will be available for 30 days.

    Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 5869256.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado; please visit www.clovisoncology.com for more information, including additional office locations in the U.S. and Europe.

    View Full Article Hide Full Article
    • Findings from Phase 1b RAMP clinical trial lay the groundwork for Phase 3 CASPAR clinical trial evaluating Rubraca® (rucaparib) and Xtandi® (enzalutamide) in combination which is expected to begin enrolling patients shortly
    • Exploratory analyses from the Phase 2 TRITON2 study demonstrate the efficacy of Rubraca in men with BRCA-mutated mCRPC despite the presence of co-occurring gene alterations in certain tumor-suppressor genes that are associated with poor prognosis

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced Rubraca data being presented at the American Society for Clinical Oncology (ASCO) Genitourinary Cancers Virtual Symposium 2021. These include data from the Phase 1b RAMP study evaluating Rubraca in combination with Xtandi…

    • Findings from Phase 1b RAMP clinical trial lay the groundwork for Phase 3 CASPAR clinical trial evaluating Rubraca® (rucaparib) and Xtandi® (enzalutamide) in combination which is expected to begin enrolling patients shortly
    • Exploratory analyses from the Phase 2 TRITON2 study demonstrate the efficacy of Rubraca in men with BRCA-mutated mCRPC despite the presence of co-occurring gene alterations in certain tumor-suppressor genes that are associated with poor prognosis

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced Rubraca data being presented at the American Society for Clinical Oncology (ASCO) Genitourinary Cancers Virtual Symposium 2021. These include data from the Phase 1b RAMP study evaluating Rubraca in combination with Xtandi, exploratory analyses from the pivotal TRITON2 study, and an analysis evaluating the rates of adverse events for different metastatic castration-resistant prostate cancer (mCRPC) treatments in a population of insured patients in the United States.

    "We are pleased to share these data with the medical and scientific community to inform choices related to mCRPC treatment. The research into co-occurring alterations in mCRPC patients with a mutation of BRCA underscores the importance of genomic testing in men with mCRPC," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Additionally, we are encouraged by the results from the RAMP study, which lay the groundwork for the Phase 3 CASPAR clinical trial sponsored by the Alliance for Clinical Trials in Oncology evaluating Rubraca and Xtandi as a novel combination therapy in men with first-line metastatic castration-resistant prostate cancer."

    Data from the RAMP study are presented by Arpit Rao, MD, Assistant Professor, Hematology, Oncology and Transplantation at the University of Minnesota. This Phase 1b study is investigating the combination of Rubraca and Xtandi in biomarker-unselected (including BRCA1/2 mutation negative) patients with mCRPC to assess the pharmacokinetics (PK) and safety of the combination. Treatment with rucaparib and enzalutamide had no clinically significant effect on the PK profiles of either drug, and the safety profile of the combination was consistent with that associated with each drug as monotherapy. The results presented at ASCO GU show that this combination is well-tolerated and without any significant drug-drug interactions. Data from the RAMP study support the randomized, placebo-controlled Phase 3 CASPAR study (Alliance A031902; NCT04455750) that is studying Rubraca and Xtandi, and is the subject of a Trial in Progress (TiP) poster being presented at the ASCO GU meeting. It is expected to begin enrolling mCRPC patients shortly.

    The CASPAR study is sponsored by the Alliance for Clinical Trials in Oncology and will enroll approximately 1,000 patients in the United States. It is expected to open at hundreds of National Clinical Trials Network (NCTN) sites nationally. This is the only combination trial of a PARP inhibitor and novel anti-androgen with an overall survival co-primary endpoint. Patients who have received prior abiraterone/apalutamide in a non-mCRPC setting are allowed to enroll to maximize applicability in the era of rapidly changing standards-of-care. The Alliance is part of the NCTN sponsored by the National Cancer Institute (NCI).

    Data from the TRITON2 clinical trial are presented by Wassim Abida MD, PhD at Memorial Sloan Kettering Cancer Center. These data underscore the antitumor activity of Rubraca among men with BRCA-mutated mCRPC and commonly co-occurring genomic alterations. Alterations in tumor suppressor genes, including TP53, PTEN and RB1, are associated with poor prognosis in patients with prostate cancer. Results from TRITON2 showed antitumor activity for Rubraca in patients with BRCA-mutated mCRPC associated with or without co-occurring alterations in these genes. There was no clear difference in radiographic and PSA response rates for patients with or without co-occurring TP53, PTEN, or RB1 alterations. Based on these results, researchers concluded that patients with mCRPC associated with a BRCA alteration should be considered for treatment with rucaparib irrespective of the presence of co-occurring alterations in these tumor suppressor genes.

    In addition, data from an analysis of clinically significant events (CSEs) associated with mCRPC treatments were presented by Kelvin A. Moses, MD, PhD, Associate Professor of Urology at Vanderbilt University Medical Center. Researchers designed the analysis to better understand the association between mCRPC treatments and development of CSEs in a population of insured patients in the United States. Using an administrative claims database for the period from January 2008 to March 2019, the analysis found that among available mCRPC treatments, chemotherapy-based regimens had the highest CSE rates per treatment year. These data indicate the burden of treatment for patients and can inform treatment decisions.

    Clovis Oncology-sponsored e-posters are available online at www.clovisoncology.com/pipeline/scientific-presentations.

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Rubraca is an unlicensed medical product outside of the U.S. and Europe

    Rubraca U.S. FDA Approved mCRPC Indication

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

    This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Click here for full Prescribing Information for Rubraca.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    About Alliance for Clinical Trials in Oncology

    The Alliance for Clinical Trials in Oncology develops and conducts clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as research methods to alleviate side effects of cancer and cancer treatments. The Alliance is part of the National Clinical Trials Network (NCTN) sponsored by the National Cancer Institute (NCI) and serves as a research base for the NCI Community Research Oncology Program (NCORP). The Alliance comprises nearly 10,000 cancer specialists at hospitals, medical centers, and community clinics across the United States and Canada. Learn more about the Alliance, visit www.AllianceforClinicalTrialsinOncology.org.

    Clovis Oncology Forward-Looking Statement

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations for the timing and pace of commencement of and enrollment in clinical trials, including those not sponsored by us, the potential results of such clinical trials, our expectations regarding the suitability of Rubraca for, and our plans to develop Rubraca in, additional indications and tumor types, and our expectations regarding the outcomes of early studies or trials supporting further development, both non-clinical and clinical. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates and those of our partners, whether future study results will be consistent with study findings to date, the timing of availability of data from our clinical trials and the initiation, enrollment, timing and results of our planned clinical trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, the risk that additional pre-clinical or clinical studies may not support further development in certain additional indications or tumor types, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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  2. Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that two abstracts featuring data from clinical studies evaluating Rubraca® (rucaparib) in metastatic castration-resistant prostate cancer (mCRPC) and one abstract describing adverse events associated with mCRPC treatment based on real world evidence have been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) 2021 Genitourinary Cancers Symposium to be held virtually, February 11-13, 2021.

    "These data underscore our continued commitment to fully understanding the clinical role of Rubraca and to accelerating the delivery of transformative therapies to the advanced prostate cancer community," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The…

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that two abstracts featuring data from clinical studies evaluating Rubraca® (rucaparib) in metastatic castration-resistant prostate cancer (mCRPC) and one abstract describing adverse events associated with mCRPC treatment based on real world evidence have been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) 2021 Genitourinary Cancers Symposium to be held virtually, February 11-13, 2021.

    "These data underscore our continued commitment to fully understanding the clinical role of Rubraca and to accelerating the delivery of transformative therapies to the advanced prostate cancer community," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The data that will be shared add to growing scientific knowledge about the science of mCRPC and broaden our understanding of Rubraca as a treatment option for patients diagnosed with mCRPC."

    The following Clovis-sponsored abstracts will be available on February 8 at 5:00 pm ET and will also be available as posters for viewing starting February 11 at 8:00 am ET on ASCO's Meeting Library. The posters can also be viewed at https://www.clovisoncology.com/pipeline/scientific-presentations/ starting February 11 at 8:00 am ET.

    Abstract Number 80: Association of co-occurring gene alterations and clinical activity of rucaparib in patients with BRCA1 or BRCA2 mutated (BRCA+) metastatic castration-resistant prostate cancer (mCRPC)

    • Poster Session: Prostate Cancer - Advanced Disease
    • Date/Time: Thursday, February 11 at 8:00 am ET
    • Lead Author: Wassim Abida, MD, PhD, Memorial Sloan Kettering Cancer Center, New York, New York

    Abstract Number 79: Rucaparib plus enzalutamide in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Pharmacokinetics (PK) and safety data from the phase 1b RAMP study

    • Poster Session: Prostate Cancer - Advanced Disease
    • Date/Time: Thursday, February 11 at 8:00 am ET
    • Lead Author: Arpit Rao, MBBS, University of Minnesota Medical School, Minneapolis, Minnesota

    Abstract Number 61: Clinically significant events associated with metastatic castration-resistant prostate cancer (mCRPC) treatments

    • Poster Session: Prostate Cancer - Advanced Disease
    • Date/Time: Thursday, February 11 at 8:00 am ET
    • Lead Author: Kelvin A. Moses, MD, PhD, FACS, Vanderbilt University Medical Center, Nashville, Tennessee

    About Rubraca (rucaparib)

    Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

    Rubraca U.S. FDA Approved mCRPC Indication

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

    This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Click here for full Prescribing Information for Rubraca.

    You may also report side effects to Clovis Oncology, Inc. at 1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US toll-free).

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in the U.S. and Europe. Please visit clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations for submission of regulatory filings, the timing and pace of commencement of and enrollment in our clinical trials, including those being planned or conducted in collaboration with partners, the potential results of such clinical trials, our expectations regarding the suitability of Rubraca for, and our plans to develop Rubraca in, additional indications and tumor types. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates and those of our partners, whether future study results will be consistent with study findings to date, the timing of availability of data from our clinical trials and the initiation, enrollment, timing and results of our planned clinical trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, the risk that additional pre-clinical or clinical studies may not support further development in certain additional indications or tumor types, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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    • Estimated $43.0M - $43.5M in Rubraca® (rucaparib) global sales for Q4 2020 and $164.2M - $164.7M for FY 2020
    • Q4/FY 2020 Operating Results call planned for February 23, 2021
    • Company to present at J.P. Morgan Healthcare Conference on Tuesday, January 12

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced its preliminary, unaudited global product revenues for the fourth quarter and full year ended December 31, 2020. The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures.

    Unaudited preliminary results include:

    • $43.0M - $43.5M in estimated Rubraca® global product revenues for the fourth quarter of 2020 compared to $38.8M for Q3 2020 and $39.3M
    • Estimated $43.0M - $43.5M in Rubraca® (rucaparib) global sales for Q4 2020 and $164.2M - $164.7M for FY 2020
    • Q4/FY 2020 Operating Results call planned for February 23, 2021
    • Company to present at J.P. Morgan Healthcare Conference on Tuesday, January 12

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced its preliminary, unaudited global product revenues for the fourth quarter and full year ended December 31, 2020. The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures.

    Unaudited preliminary results include:

    • $43.0M - $43.5M in estimated Rubraca® global product revenues for the fourth quarter of 2020 compared to $38.8M for Q3 2020 and $39.3M for Q4 2019;
      • U.S. product revenues of approximately $36.3M - $36.7M and E.U. of $6.5M - $6.8M
      • Highest quarterly global and E.U. product revenues to date
    • $164.2M -$164.7M in estimated Rubraca product revenues for FY 2020 compared to $143.0M for FY 2019
    • Approximately $240M in cash and cash equivalents at December 31, 2020 which is expected to fund the Company's operating plan into early 2023 based on current revenue and expense forecasts

    Clovis plans to discuss these results with investors this week at the 39th Annual J.P. Morgan Healthcare Conference which is being held virtually January 10-14, 2021.

    "We are pleased with our strong finish to a challenging year, including achieving record quarterly and annual sales," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We believe we have set the stage for an important year in 2021, as we seek to continue to grow Rubraca sales and advance our pipeline, including plans to report top-line ATHENA monotherapy data in the second half of the year, initiate a clinical development program for FAP-2286 in the first half of the year, and show initial efficacy data for the LIO-1 lucitanib and Opdivo combination trial at a medical meeting this year."

    Clovis Oncology to Present at 39th Annual J.P. Morgan Healthcare Conference on January 12

    Clovis' President and CEO, Patrick J. Mahaffy, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12 at 4:30 p.m. ET. A live webcast of the presentation/Q&A session can be accessed through the investor relations section of the Company's website at clovisoncology.com. Approximately 24 hours following the live presentation, a replay of the webcast will be available on the Company's website for 30 days.

    Fourth Quarter and Full Year 2020 Financial Results Release Planned for February 23

    The Company plans to report financial results for the fourth quarter and full year ended December 31, 2020 on Tuesday, February 23, 2021, before the open of the U.S. financial markets. Clovis' senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the Company's results in greater detail.

    About Rubraca (rucaparib)

    Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

    In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

    In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

    Rubraca is an unlicensed medical product outside of the U.S. and Europe.

    About Lucitanib



    Lucitanib is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

    Lucitanib is an unlicensed medical product.

    About FAP-2286

    FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two parts; a peptide that binds to FAP and a linker and site that can be used to attach radiation for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.i Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey and Israel.

    FAP-2286 is an unlicensed medical product.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in the U.S. and Europe. Please visit clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our preliminary estimates of fourth quarter and fiscal year 2020 revenue and cash, cash equivalents and available for sale securities, and our expectations for our future cash position, commencement of clinical trials, availability of study data and submission of regulatory filings. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the impacts of the COVID-19 pandemic and disruption related to efforts to mitigate its spread on our business, results of operations or financial condition, including impacts on the vendors or distribution channels in our supply chain, impacts on our contract manufacturers' ability to continue to manufacture our products, impacts on our ability to continue our development activities, impacts on the conduct of our clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites or monitoring of data and impact on the ability and timing of our field personnel to conduct their activities with health care providers, the uncertainties inherent in the effect our future revenues or expenses may have on our cash position, the market potential of our approved drug, including the performance of our sales and marketing efforts and the success of competing drugs and therapeutic approaches, changes in gross-to-net or free drug provided through our patient assistance program, the availability of reimbursement and insurance coverage, the timing of availability of data from our clinical trials, the uncertainties inherent in actions or decisions by the FDA, the EMA or other regulatory authorities regarding whether to accept or approve drug applications that may be filed, including delays or denials of regulatory approvals, clearances or authorizations for applications, as well as their decisions regarding drug labeling, reimbursement and pricing. Furthermore, we are in the process of finalizing our financial results for the fourth quarter and fiscal year 2020, and therefore our finalized and audited results and final analysis of those results are not yet available. The preliminary expectations regarding 2020 revenue and year-end cash, cash equivalents and available for sale securities are subject to management's review and actual results could differ from management's expectations. The actual results are also subject to audit by our independent registered public accounting firm and no assurance is given by our independent registered public accounting firm on such preliminary expectations. You should not draw any conclusions as to any other financial results as of and for the year ended December 31, 2020 based on the foregoing estimates. These forward-looking statements speak only as of the date hereof. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

    i Rettig WJ et al. Regulation and Heteromeric Structure of the Fibroblast Activation Protein in Normal and Transformed Cells of Mesenchymal and Neuroectodermal Origin. Cancer Res. 1993;53:3327–3335.

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    • Initiation of Phase 1/2 clinical study of novel peptide-targeted radionuclide therapy and imaging agent targeting fibroblast activation protein (FAP) expected 1H 2021
    • Will be the first peptide-targeted radionuclide therapy targeting FAP to enter clinical development

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that the company has completed submission of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for FAP-2286, the lead compound in its peptide-targeted radionuclide therapy (PTRT) development program. Following clearance of the INDs by FDA, Clovis plans to initiate a Phase 1/2 clinical study of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286) to determine the dose and tolerability of…

    • Initiation of Phase 1/2 clinical study of novel peptide-targeted radionuclide therapy and imaging agent targeting fibroblast activation protein (FAP) expected 1H 2021
    • Will be the first peptide-targeted radionuclide therapy targeting FAP to enter clinical development

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that the company has completed submission of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for FAP-2286, the lead compound in its peptide-targeted radionuclide therapy (PTRT) development program. Following clearance of the INDs by FDA, Clovis plans to initiate a Phase 1/2 clinical study of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286) to determine the dose and tolerability of the FAP-targeting therapeutic agent (Phase 1), with expansion cohorts planned in multiple tumor types (Phase 2). FAP-2286 labelled with gallium-68 (68Ga-FAP-2286) will be utilized as a diagnostic to identify patients with fibroblast activation protein (FAP)-positive tumors appropriate for treatment with the therapeutic agent.

    "Submission of these INDs is a very important milestone in the development of FAP-2286, the first clinical candidate from our PTRT platform," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Targeted radiopharmaceuticals represent an emerging therapeutic class and an area of significant interest to the clinical community, and FAP is considered a target of particular interest given its high, selective expression in multiple solid tumors. We are enthusiastic about the opportunity to become a leader in the rapidly evolving field of PTRT, and the first to begin clinical development of a peptide-targeted radionuclide therapy targeting FAP."

    Fibroblast activation protein (FAP) is a cell-surface protein that is expressed in limited amounts by normal tissues, but highly expressed in cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.i,ii,iii Preclinical data demonstrate that 177Lu-FAP-2286 potently and selectively binds FAP on the surface of CAFs and tumor cells to deliver the beta-particle emitting radioisotope 177Lu, resulting in DNA damage and cell death.vi,iv Compelling anti-tumor efficacy of 177Lu-FAP-2286 has been demonstrated in FAP-expressing preclinical tumor models.v

    Following clearance of the INDs by FDA, the Phase 1/2 study LuMIERE is planned to start in the first half of 2021 to determine the dose of 177Lu-FAP-2286 to be used in Phase 2 development. The FAP-targeting imaging agent, 68Ga-FAP-2286, will be used to identify patients with FAP-positive tumors eligible for treatment with 177Lu-FAP-2286 in the study. Once the Phase 2 dose is determined, expansion cohorts will evaluate 177Lu-FAP-2286 and 68Ga-FAP-2286 in multiple tumor types.

    About Peptide-Targeted Radionuclide Therapy

    Peptide-targeted radionuclide therapy (PTRT) is a form of targeted radiotherapy that is emerging as a new treatment option for patients with cancervi. These therapies consist of a small amount of a radioactive isotope, known as a radionuclide, linked to cell-targeting peptide that binds to a cancer specific protein which selectively directs the radionuclide to tumors.v Following binding, the radionuclide warhead emits ionizing radiation causing DNA damage and cell death to neighboring tumor cells.vii

    About FAP-2286

    FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two parts; a peptide that binds to FAP and a linker and site that can be used to attach radiation for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.iii Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey and Israel. FAP-2286 is an unlicensed medical product.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements our intentions and expectations for our development and discovery programs, including the timing and pace of pre-clinical development, plans for clinical development, plans for additional applications of the FAP-2286 peptide, including combination trials, and regulatory plans with respect to FAP-2286. Such forward-looking statements involve substantial risks and uncertainties that could cause Clovis Oncology's actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in drug discovery and pre-clinical and clinical development, including the outcome of pre-clinical studies and clinical trials, whether initial results, findings or research will support future studies or development, whether future study results will be consistent with previous study findings or other results, including pre-clinical studies, results in named-patient or similar programs or clinical trials, whether additional studies not originally contemplated are determined to be necessary, the timing of initiation, enrollment and completion of planned studies and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its other reports filed with the Securities and Exchange Commission.

    i Garin-Chesa P et al. Cell surface glycoprotein of reactive stromal fibroblasts as a potential antibody target in human epithelial cancers. Proc Natl Acad Sci U S A. 1990;87(18):7235-9.

    ii Park JE et al. Fibroblast activation protein, a dual specificity serine protease expressed in reactive human tumor stromal fibroblasts. J Biol Chem. 1999;274(51):36505-12.

    iii Rettig WJ et al. Regulation and Heteromeric Structure of the Fibroblast Activation Protein in Normal and Transformed Cells of Mesenchymal and Neuroectodermal Origin. Cancer Res. 1993;53:3327–3335.

    iv Yong KJ et al. Mechanisms of Cell Killing Response from Low Linear Energy Transfer (LET) Radiation Originating from 177Lu Radioimmunotherapy Targeting Disseminated Intraperitoneal Tumor Xenograpfts. Int. J. of Mol.Sci. 2016; 17: 736.

    v Zboralski, D et al. Preclinical evaluation of FAP-2286, a peptide-targeted radionuclide therapy (PTRT) to fibroblast activation protein alpha (FAP). European Society for Medical Oncology (ESMO) Congress 2020. 18-22 September 2020. Madrid, Spain.

    vi Grzmil M, Meisel A, Behé M., Schibli R. (2019) An Overview of Targeted Radiotherapy. In: Lewis J., Windhorst A., Zeglis B. (eds) Radiopharmaceutical Chemistry. Springer, Cham.

    vii National Research Council 2007. Advancing Nuclear Medicine Through Innovation. Washington, DC: The National Academies Press. https://doi.org/10.17226/11985.

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    • The ARIEL4 study met its primary endpoint, showing a statistically significant improvement in progression-free survival for Rubraca versus chemotherapy
    • The safety of Rubraca observed in the ARIEL4 study was highly consistent with both the U.S. and EU labels
    • An expanded description of the ARIEL4 study results will be submitted for presentation at an upcoming medical meeting

    Clovis Oncology, Inc. (NASDAQ:CLVS), today announced topline data from the randomized Phase 3 ARIEL4 study of Rubraca, which met its primary endpoint of improved investigator-assessed progression-free survival (InvPFS) compared to chemotherapy in relapsed ovarian cancer patients with a tumor mutation of BRCA who have received two or more prior lines of chemotherapy…

    • The ARIEL4 study met its primary endpoint, showing a statistically significant improvement in progression-free survival for Rubraca versus chemotherapy
    • The safety of Rubraca observed in the ARIEL4 study was highly consistent with both the U.S. and EU labels
    • An expanded description of the ARIEL4 study results will be submitted for presentation at an upcoming medical meeting

    Clovis Oncology, Inc. (NASDAQ:CLVS), today announced topline data from the randomized Phase 3 ARIEL4 study of Rubraca, which met its primary endpoint of improved investigator-assessed progression-free survival (InvPFS) compared to chemotherapy in relapsed ovarian cancer patients with a tumor mutation of BRCA who have received two or more prior lines of chemotherapy.

    "We are pleased with these topline results from the ARIEL4 trial, which confirm the clinical benefit of Rubraca versus chemotherapy, including platinum-based chemotherapy, as a treatment for women with BRCA mutation-positive advanced ovarian cancer, including patients who are platinum-resistant," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to sharing comprehensive results at an upcoming medical meeting."

    The ARIEL4 study (NCT02855944) is a Phase 3 multicenter, randomized study evaluating Rubraca versus chemotherapy in platinum-sensitive, partially platinum-sensitive and platinum-resistant patients with relapsed ovarian cancer and a BRCA mutation (inclusive of germline and/or somatic) who have received two or more prior lines of chemotherapy. The primary endpoint of the study is InvPFS, with a step down analysis from the efficacy population (if significant) to the ITT population. The efficacy population comprised the group of patients with a deleterious tumor BRCA mutation and excluded those with a BRCA reversion mutation as determined by a blood test developed by Guardant Health. Development of reversion mutations that restore BRCA protein function are associated with resistance to platinum-based chemotherapies and PARP inhibitors in BRCA-mutant cancers, and these occur more frequently in platinum-resistant vs platinum-sensitive patients (13% and 2% respectively in the ARIEL2 study).i

    Completion of ARIEL4 is a post-marketing commitment in the U.S. and EU.

    349 women were enrolled in North and South America, Europe and Israel. The efficacy population (n=325) comprised the group of patients with a deleterious tumor BRCA mutation and excluded those with a BRCA reversion mutation. The rucaparib arm (n=220) successfully achieved statistical significance over the chemotherapy arm (n=105) for the primary endpoint of InvPFS with a hazard ratio of 0.639 (p=0.0010). The median PFS for the patients in the efficacy population treated with rucaparib was 7.4 months vs. 5.7 months among those who received chemotherapy.

    In addition, in the ITT population (n=349), the rucaparib arm (n=233) successfully achieved statistical significance over the chemotherapy arm (n=116) for the primary endpoint of InvPFS with a hazard ratio of 0.665 (p=0.0017). The median PFS for the patients in the ITT population treated with rucaparib was 7.4 months vs. 5.7 months among those who received chemotherapy.

    Patients with a BRCA reversion mutation represented 7 percent of patients enrolled in the study and as anticipated, InvPFS results for those patients showed limited benefit from Rubraca therapy.

    An interim analysis of overall survival, a secondary endpoint in the study in which 51 percent of events have occurred in the ITT population, showed a trend toward an overall survival (OS) advantage in the chemotherapy arm, but was confounded by the high rate (64%) of per-protocol crossover to Rubraca following progression on chemotherapy. Importantly, an analysis of the ITT population of patients showed a trend toward an OS advantage for those patients who received Rubraca at any point in the trial versus those who did not.

    Adverse events were consistent with the known safety profiles of Rubraca and chemotherapy.

    The most common (>5%) treatment-emergent grade 3/4 adverse events (TEAEs) among all patients treated with rucaparib (n=232) in the ARIEL4 study were anemia/decreased hemoglobin (22%), neutropenia/decreased absolute neutrophil count (10%), asthenia/fatigue (8%), thrombocytopenia/decreased platelets (8%), and increased ALT/AST (8%).

    "The ARIEL4 study verified that women with relapsed, BRCA mutation-positive advanced ovarian cancer, including those who are platinum-sensitive or -resistant, received benefit with rucaparib treatment when compared to chemotherapy," said Dr. Amit Oza, Head of the Division of Medical Oncology & Hematology, Medical Director of the Cancer Clinical Research Unit at Princess Margaret (PM) Cancer Centre, co-Director of the Drug Development Program at PM Cancer Centre, Senior Scientist at the Princess Margaret Cancer Centre, and Professor of Medicine at University of Toronto. "These results underscore the importance of rucaparib as a treatment option for women with BRCA-mutant advanced ovarian cancer."

    Ovarian cancer ranks fifth in cancer deaths among women in the U.S.ii and EUiii. While there are a growing number of therapies to treat ovarian cancer, after initial therapy, 70-90% of U.S. womeniv with advanced disease will recur. In the EU, approximately 70% of patients experience a relapse within three years following initial therapy.v

    "Ovarian cancer remains a lethal gynecologic cancer and there are limited treatment options for relapsed disease," said Dr. Rebecca Kristeleit, Co-Chief Investigator of ARIEL4 and Consultant Medical Oncologist, London, UK. "There is a need for therapies that can extend time to progression. The ARIEL4 data confirm the clinical relevance of BRCA reversion mutations and advance our understanding of how best to manage the treatment of women with advanced ovarian cancer."

    Drs. Rebecca Kristeleit and Amit Oza are coordinating investigators on the ARIEL4 study. Clovis Oncology plans to provide an expanded description of the ARIEL4 results at a medical meeting in 2021.

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

    Rubraca Ovarian Cancer U.S. FDA Approved Indications

    Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

    Rubraca is indicated for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) have occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.

    Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

    Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

    Click here for full Prescribing Information and additional Important Safety Information.

    Rubraca (rucaparib) European Union (EU) authorized use and Important Safety Information

    Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

    Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with ≥2 prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

    Efficacy of Rubraca as treatment for relapsed or progressive epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) has not been investigated in patients who have received prior treatment with a PARP inhibitor. Therefore, use in this patient population is not recommended.

    Summary warnings and precautions:

    Hematological toxicity

    During treatment with Rubraca, events of myelosuppression (anemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8–10 weeks of treatment with Rubraca. These reactions are manageable with routine medical treatment and/or dose adjustment for more severe cases. Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised. Patients should not start Rubraca treatment until they have recovered from hematological toxicities caused by previous chemotherapy (CTCAE grade ≥1).

    Supportive care and institutional guidelines should be implemented for the management of low blood counts for the treatment of anemia and neutropenia. Rubraca should be interrupted or dose reduced according to Table 1 (see Posology and Method of Administration [4.2] of the Summary of Product Characteristics [SPC]) and blood counts monitored weekly until recovery. If the levels have not recovered to CTCAE grade 1 or better after 4 weeks, the patient should be referred to a hematologist for further investigations.

    MDS/AML

    MDS/AML, including cases with fatal outcome, have been reported in patients who received Rubraca. The duration of therapy with Rubraca in patients who developed MDS/AML varied from less than 1 month to approximately 28 months.

    If MDS/AML is suspected, the patient should be referred to a hematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics. If, following investigation for prolonged hematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.

    Photosensitivity

    Photosensitivity has been observed in patients treated with Rubraca. Patients should avoid spending time in direct sunlight because they may burn more easily during Rubraca treatment; when outdoors, patients should wear a hat and protective clothing, and use sunscreen and lip balm with sun protection factor of 50 or greater.

    Gastrointestinal toxicities

    Gastrointestinal toxicities (nausea and vomiting) are frequently reported with Rubraca, and are generally low grade (CTCAE grade 1 or 2), and may be managed with dose reduction (refer to Posology and Method of Administration [4.2], Table 1 of the SPC) or interruption. Antiemetics, such as 5-HT3 antagonists, dexamethasone, aprepitant and fosaprepitant, can be used as treatment for nausea/vomiting and may also be considered for prophylactic (i.e. preventative) use prior to starting Rubraca. It is important to proactively manage these events to avoid prolonged or more severe events of nausea/vomiting which have the potential to lead to complications such as dehydration or hospitalization.

    Embryofetal toxicity

    Rubraca can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. In an animal reproduction study, administration of Rubraca to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see Preclinical Safety Data [5.3] of the SPC).

    Pregnancy/contraception

    Pregnant women should be informed of the potential risk to a fetus. Women of reproductive potential should be advised to use effective contraception during treatment and for 6 months following the last dose of Rubraca (see section 4.6 of the SPC). A pregnancy test before initiating treatment is recommended in women of reproductive potential.

    Click here to access the current SPC. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations for submission of regulatory filings, the timing and pace of commencement of and enrollment in our clinical trials, including those being planned or conducted in collaboration with partners, the potential results of such clinical trials, our expectations regarding the suitability of Rubraca, and our plans to develop Rubraca in additional indications and tumor types, and our expectations regarding the outcomes of early studies or trials supporting further development, both non-clinical and clinical. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates and those of our partners, whether future study results will be consistent with study findings to date, the timing of availability of data from our clinical trials and the initiation, enrollment, timing and results of our planned clinical trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, the risk that additional pre-clinical or clinical studies may not support further development in certain additional indications or tumor types, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

    ___________________________

    i Lin et al. BRCA Reversion Mutations in Circulating Tumor DNA Predict Primary and Acquired Resistance to the PARP Inhibitor Rucaparib in High-Grade Ovarian Carcinoma. Cancer Discovery. 2019. https://cancerdiscovery.aacrjournals.org/content/9/2/210. Last accessed December 2020.

    ii American Cancer Society. Cancer Facts & Figures 2018. Atlanta, GA: American Cancer Society; 2018.

    iii World Health Organization. GLOBOCAN: estimated cancer incidence, mortality and prevalence worldwide in 2018. Available at http://gco.iarc.fr/. Last accessed December 2020.

    iv Ovarian Cancer Research Alliance (OCRA) https://ocrahope.org/patients/about-ovarian-cancer/recurrence/ Last accessed December 2020.

    v Ledermann J et al. Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24(suppl 6):vi24-32.

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  3. Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that pursuant to the terms of that previously announced Exchange and Purchase Agreement, dated as of November 4, 2020, by and between Clovis Oncology and an existing holder of its securities named therein (the "Holder") relating to the offering of the Company's new series of 4.50% Convertible Senior Notes due 2024 (the "New 2024 Notes"), such Holder has elected to exercise its option to purchase an additional $7.5 million aggregate principal amount of the New 2024 Notes on the same terms. The settlement of the option is expected to occur on November 27, 2020, subject to customary closing conditions. Following the closing, there will be a total of $57.5 million aggregate principal amount of…

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that pursuant to the terms of that previously announced Exchange and Purchase Agreement, dated as of November 4, 2020, by and between Clovis Oncology and an existing holder of its securities named therein (the "Holder") relating to the offering of the Company's new series of 4.50% Convertible Senior Notes due 2024 (the "New 2024 Notes"), such Holder has elected to exercise its option to purchase an additional $7.5 million aggregate principal amount of the New 2024 Notes on the same terms. The settlement of the option is expected to occur on November 27, 2020, subject to customary closing conditions. Following the closing, there will be a total of $57.5 million aggregate principal amount of the New 2024 Notes outstanding.

    Clovis Oncology intends to use the net proceeds from the sale of the New 2024 Notes for general corporate purposes, including repayment, repurchase or refinance of its debt obligations, sales and marketing expenses associated with Rubraca® (rucaparib), funding of its development programs, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

    The offer and sale of the New 2024 Notes and the shares of common stock issuable upon conversion of such New 2024 Notes have not been registered under the Securities Act or any state securities laws and, unless so registered, the New 2024 Notes and any such shares may not be offered or sold in the United States except pursuant to an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy the New 2024 Notes or any other securities, nor will there be any sale of New 2024 Notes or any other securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado with additional office locations in the U.S. and Europe.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Such forward-looking statements involve substantial risks and uncertainties that could cause Clovis Oncology's actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the conditions affecting the capital markets, general economic, industry, or political conditions, and the satisfaction of customary closing conditions related to the proposed offering. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its other reports filed with the Securities and Exchange Commission.

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  4. Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that a pre-recorded fireside chat with President and Chief Executive Officer Patrick J. Mahaffy will be available next week for replay as part of the Piper Sandler 32nd Annual Healthcare Conference. The virtual conference, which takes place November 30 to December 3, 2020, incorporates a library of pre-recorded fireside chat presentations with presenting companies available on Monday, November 23, 2020 at 10:00 a.m. Eastern time.

    This conference is virtual and the pre-recorded presentation can be accessed through the investor relations section of the Company's website at www.clovisoncology.com. The replay of the webcast will be available on the Company's website for 30 days. The presentation…

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that a pre-recorded fireside chat with President and Chief Executive Officer Patrick J. Mahaffy will be available next week for replay as part of the Piper Sandler 32nd Annual Healthcare Conference. The virtual conference, which takes place November 30 to December 3, 2020, incorporates a library of pre-recorded fireside chat presentations with presenting companies available on Monday, November 23, 2020 at 10:00 a.m. Eastern time.

    This conference is virtual and the pre-recorded presentation can be accessed through the investor relations section of the Company's website at www.clovisoncology.com. The replay of the webcast will be available on the Company's website for 30 days. The presentation was recorded on November 18, 2020, and statements made in the presentation speak only as of such date. Clovis Oncology does not undertake to update or revise any statements made therein.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado; please visit www.clovisoncology.com for more information, including additional office locations in the U.S. and Europe.

    To the extent that statements contained in the pre-recorded presentation are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in such presentation include, among others, statements regarding our expectations for commercial launches, availability of study data and submission of regulatory filings. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, whether future study results will support continued development, the timing of availability of data from our clinical trials, the uncertainties inherent in actions or decisions by the FDA, the EMA or other regulatory authorities regarding whether to accept or approve drug applications that may be filed, including delays or denials of regulatory approvals, clearances or authorizations for applications, as well as their decisions regarding drug labeling, reimbursement and pricing. These forward-looking statements speak only as of the date hereof. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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    • $38.8M in Rubraca® (rucaparib) global sales for Q3 2020; net product revenue up 3% over Q3 2019
    • Global net product revenue guidance provided for Q4 2020 in a range of $38M to $40M
    • Restructuring U.S. commercial organization to adopt hybrid strategy elevating digital programming and peer-to-peer interactions
    • Oncology pipeline, inclusive of Rubraca, lucitanib and FAP-2286, expected to result in multiple key clinical, development and regulatory milestones during 2021
    • $224.7M in cash and cash equivalents at September 30, 2020, which is anticipated to fund the Company's operating plan into early 2022
    • Assuming completion of the offering of $50M of convertible notes announced today, the additional cash proceeds are anticipated to fund
    • $38.8M in Rubraca® (rucaparib) global sales for Q3 2020; net product revenue up 3% over Q3 2019
    • Global net product revenue guidance provided for Q4 2020 in a range of $38M to $40M
    • Restructuring U.S. commercial organization to adopt hybrid strategy elevating digital programming and peer-to-peer interactions
    • Oncology pipeline, inclusive of Rubraca, lucitanib and FAP-2286, expected to result in multiple key clinical, development and regulatory milestones during 2021
    • $224.7M in cash and cash equivalents at September 30, 2020, which is anticipated to fund the Company's operating plan into early 2022
    • Assuming completion of the offering of $50M of convertible notes announced today, the additional cash proceeds are anticipated to fund the Company's operating plan into early 2023

    Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended September 30, 2020, and provided an update on the Company's clinical development programs and regulatory and commercial outlook for the rest of the year.

    "We are pleased that third quarter revenues for Rubraca grew slightly over the same period in 2019, despite a very challenging sales environment caused by COVID-19, which has severely limited oncology patient visits and cancer diagnoses. In addition, oncology practices have substantially limited traditional in-person sales calls – a trend that we see accelerating – and physicians increasingly prefer digital communications and virtual peer-to-peer interactions. In response to this evolving U.S. oncology market, we are shifting to a hybrid commercial strategy to support these preferences. This new strategy incorporates more targeted in-person promotion, online resources for prescribers customized to their practices and new approaches to peer-to-peer interactions. We believe this hybrid strategy will increase awareness and interest in Rubraca. We have undertaken this change with the goal of returning to growth as rapidly as we can, despite cancer diagnoses and cancer patient visits currently remaining lower than pre-COVID-19," said Patrick J. Mahaffy, President and CEO of Clovis Oncology.

    "We also remain focused on our growing pipeline activities and in 2021, we anticipate multiple meaningful clinical, development and regulatory milestones. For Rubraca, we anticipate data from the ATHENA monotherapy arm, and pending data, a potential sNDA filing for the LODESTAR pan-tumor study in the second half of 2021. Interim updates from the LIO-1 study of Rubraca and Opdivo in combination are anticipated in 2021. Following allowance of the IND filings for our peptide-targeted radiotherapeutic candidate, FAP-2286, planned for submission this quarter, we plan to initiate a robust clinical development program in early 2021," Mr. Mahaffy continued.

    Third Quarter 2020 Financial Results

    Clovis reported net product revenue for Rubraca of $38.8 million for the third quarter of 2020, which included U.S. product revenue of $33.9 million and ex-U.S. product revenue of $4.9 million, compared to net product revenue for Q3 2019 of $37.6 million, which included U.S. net product revenue of $36.5 million and ex-U.S. net product revenue of $1.1 million.

    Clovis reported net product revenue for Rubraca of $121.2 million for the nine months ended September 30, 2020, which included U.S. product revenue of $109.8 million and ex-U.S. product revenue of $11.4 million, compared to net product revenue for same period in 2019 of $103.7 million, which included U.S. net product revenue of $101.1 million and ex-U.S. net product revenue of $2.6 million.

    Clovis Oncology expects global net product revenue for the fourth quarter 2020 to be in a range of $38 million to $40 million. The effects of COVID-19 on future sales are difficult to predict, especially with the increase in COVID-19 cases in the U.S. and Europe.

    Research and development expenses totaled $62.9 million for Q3 2020 and $201.0 million for the first nine months of 2020, compared to $77.9 million and $210.7 million for the comparable periods in 2019. Research and development expenses decreased for the third quarter and the first nine months of 2020 compared to the same periods in the prior year due primarily to lower spending on Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to full year 2020.

    Selling, general and administrative expenses totaled $38.6 million for Q3 2020 and $123.1 million for the first nine months of 2020, compared to $41.8 million and $137.6 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the third quarter and first nine months of 2020 compared to the same period in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts.

    Clovis reported a net loss for the third quarter of 2020 of $78.7 million, or ($0.89) per share, and a net loss of $270.3 million, or ($3.37) per share, for the first nine months of 2020. Net loss for Q3 2019 was $94.1 million, or ($1.72) per share, and $300.9 million, or a net loss of ($5.62) per share, for the first nine months of 2019. Net loss for Q3 and the first nine months of 2020 included share-based compensation expense of $12.5 million and $38.8 million, compared to $14.0 million and $41.7 million for the comparable periods of 2019.

    Clovis had $224.7 million in cash and cash equivalents as of September 30, 2020.

    As of September 30, 2020, the Company had drawn approximately $85 million under the TPG ATHENA clinical trial financing and had up to $90 million available to draw under the agreement to fund the expenses of the ATHENA trial through Q3 2022.

    Based on the Company's anticipated revenues, spending, available financing sources and existing cash and cash equivalents, the Company believes it has sufficient cash and cash equivalents to fund its operating plan into early 2022, after taking into account any cash repayment (unless refinanced earlier) of the remaining $64.42 million aggregate principal amount of the 2.50% convertible notes, at their maturity in September 2021. Assuming the completion of the offering of $50 million of convertible notes announced today, the additional cash proceeds are anticipated to fund the Company's operating plan into early 2023.

    Net cash used in operating activities was $54.3 million for the third quarter of 2020, down from $57.0 million reported in the third quarter of 2019. Similarly, net cash used in operating activities for the first nine months of 2020 was $196.7 million, compared with $253.5 million for the first nine months of 2019.

    Cash burn in Q3 2020 was $37.7 million, which represents a 25 percent sequential decrease from the Q2 2020 cash burn of $50.1 million. Borrowings under the TPG ATHENA financing provided $16.6 million in cash in Q3 2020. Cash burn in the first nine months of 2020 was $154.7 million.

    Restructured U.S. Commercial Organization

    The COVID-19 pandemic has accelerated a preference by oncology practices for more digital programming, including digital peer-to-peer interactions and reduced in-person promotion. In order to meet these changing preferences, the Company is adopting a hybrid commercial strategy combining increased digital promotional activities, greater online resources and more peer-to-peer interactions with reduced and more targeted in-person promotion. Accordingly, new tools and performance indicators based on this hybrid approach are being rolled out during the fourth quarter, and the U.S. commercial organization has been reduced in size by approximately 45 employees. Despite increased investment in digital promotion, we anticipate an effect of adopting this hybrid model will result in annual cost-savings of approximately $10 million. The Company is adopting this strategy in order to better reach customers in the way they want to be reached with the goal of returning to growth, especially as the ongoing impact of COVID-19 is reduced.

    FDA-approved Companion Diagnostic to Identify Eligible mCRPC Patients Added to Rubraca U.S. Label

    In late August, the U.S. FDA approved the FoundationOne® Liquid CDx, Foundation Medicine's comprehensive liquid biopsy test for all solid tumors with multiple companion diagnostic indications, including for Rubraca. It is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies, including Rubraca. In early October, the companion diagnostic for Rubraca in mCRPC was added to the Rubraca U.S. label.

    These events follow the U.S. FDA's May 2020 approval of Rubraca for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated mCRPC who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this indication under accelerated approval based on objective response rate and duration of response data from the multi-center, single arm TRITON2 clinical trial.

    Data from the TRITON2 study of Rubraca for the treatment of mCRPC harboring BRCA1/2 mutations were published online in the Journal of Clinical Oncology during the quarter. These results supported the May approval and provide additional detail for physicians about the study and about Rubraca as a treatment option for eligible men with mCRPC and a deleterious BRCA1/2 mutation.

    Initial Presentations for Lucitanib and Rucaparib Combinations and Preclinical Data for FAP-2286 at Medical Meetings

    Six e-posters for Clovis' three portfolio compounds were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 in September. These included the following:

    • Initial data from the Phase 1b part of the LIO-1 trial of lucitanib combined with Opdivo® (nivolumab) in advanced metastatic solid tumors which identified a recommended Phase 2 dose and showed promising signs of antitumor activity; also, a Trials In Progress e-poster describing the Phase 2 study currently enrolling patients.
    • The first presentation of preclinical data for FAP-2286, a novel peptide-targeted radionuclide therapy (PTRT), showed the compound potently and selectively binds fibroblast activation protein (FAP); in addition, compelling anti-tumor activity was observed in FAP-expressing tumor models.
    • New data analyses from pivotal Rubraca studies ARIEL3 and TRITON2 further characterized its safety profile in recurrent ovarian cancer and metastatic castration-resistant prostate cancer (mCRPC), respectively.
    • Encouraging initial data from the SEASTAR study evaluating Rubraca in combination with Trodelvy™ (sacituzumab govitecan-hziy).

    In addition, in an oral plenary session at the International Gynecologic Cancer Society (IGCS) Digital Annual Global Meeting in September, data from an exploratory analysis of the ARIEL3 clinical study evaluating Rubraca as maintenance treatment in recurrent ovarian cancer were presented. The findings demonstrate that rucaparib maintenance treatment can lead to a clinically meaningful delay in starting subsequent therapy and lasting clinical benefits in patients with BRCA1- or BRCA2-mutant ovarian cancer.

    The data described here are available online at www.clovisoncology.com/pipeline/scientificpresentations.

    Lucitanib Combination Studies Underway

    The Phase 2 portion of LIO-1 trial evaluating lucitanib and Opdivo in combination in advanced solid tumors (Phase 1b) and gynecologic cancers (Phase 2) is open for enrollment and the first patient was treated in August. Clovis intends to submit updated interim data from the LIO-1 study for presentation at a 2021 medical meeting.

    FAP-2286 and Radionuclide Therapy Development Program

    Clovis intends to submit two Investigational New Drug (IND) applications for FAP-2286 for use as imaging and treatment agents respectively. Following allowance of the INDs by the U.S. FDA, Clovis will initiate a Phase 1 study to determine the dose and tolerability of the FAP-targeting therapeutic agent, with expansion cohorts planned in multiple tumor types. The FAP-targeting imaging agent will be utilized to identify tumors that contain FAP for treatment in the Phase 1 study.

    Conference Call Details

    Clovis will hold a conference call to discuss Q3 2020 results this morning, November 5, at 8:30am ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 2999168.

    About Rubraca (rucaparib)

    Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

    In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on a FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

    In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

    Rubraca is an unlicensed medical product outside of the U.S. and Europe.

    About Lucitanib

    Lucitanib is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

    Lucitanib is an unlicensed medical product.

    About FAP-2286

    FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis holds U.S. and global rights for FAP-2286 excluding Europe.

    FAP-2286 is an unlicensed medical product.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our future financial and operating performance, business plans or prospects, including expectations concerning our future cash position and future revenue expectations from the sale of Rubraca, our expectations regarding the impact of COVID-19 on our business operations and results, including future revenues, supply and distribution of our clinical trial supplies and commercial product supplies, our expectations regarding our ability to maintain the enrollment and conduct of our clinical trials and other development activities, expectations concerning future regulatory activities, expectations for submission of regulatory filings, our plans to present final or interim data on ongoing clinical trials, our plans to submit additional data to, or meet with, the FDA with respect to the status of or plans for ongoing or planned trials, the timing and pace of commencement of enrollment in and conduct of our clinical trials and the cost of certain trials, including those being considered, planned or conducted in collaboration with partners, our plans for commencement of additional planned trials, the potential results of such clinical trials, changes in drug supply timing and costs and other expenses and statements regarding our expectations of the supply of free drug distributed to eligible patients and our expectations regarding the funding that may be available to us under the agreement with TPG Sixth Street Partners. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the impacts of the COVID-19 pandemic and disruption related to efforts to mitigate its spread on our business, results of operations or financial condition, including impacts on the vendors or distribution channels in our supply chain, impacts on our contract manufacturers' ability to continue to manufacture our products, impacts on our ability to continue our development activities, impacts on the conduct of our clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites or monitoring of data and impact on the ability and timing of our field personnel to conduct their activities with health care providers, the uncertainties inherent in the effect our future revenues or expenses may have on our cash position, the market potential of our approved drug, including the performance of our sales and marketing efforts and the success of competing drugs and therapeutic approaches, changes in gross-to-net or free drug provided through our patient assistance program, the availability of reimbursement and insurance coverage, the performance of our third-party manufacturers, whether our clinical development programs for our drug candidates and those of our partners can be completed on time or at all, whether future study results will be consistent with study findings to date and whether future study results will support continued development or regulatory approval, the corresponding development pathways of our companion diagnostics, the timing of availability of data from our clinical trials and the results, the initiation, enrollment, timing and results of our planned clinical trials, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to accept or approve drug applications that may be filed, their interpretations of our data and agreement with our regulatory approval strategies or components of our filings, including our clinical trial designs, conduct and methodologies, as well as their decisions regarding drug labeling, reimbursement and pricing, and other matters that could affect the development, approval, availability or commercial potential of our drug candidates or companion diagnostics. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

    CLOVIS ONCOLOGY, INC
    CONSOLIDATED FINANCIAL RESULTS
    (Unaudited, in thousands, except per share amounts)
     

    Three Months Ended September 30,

     

    Nine Months Ended September 30,

     

    2020

     

     

    2019

     

     

     

    2020

     

     

    2019

     

    Revenues:
    Product revenue

    $

    38,772

     

    $

    37,603

     

    $

    121,223

     

    $

    103,699

     

     
    Operating expenses:
    Cost of sales - product

     

    8,438

     

     

    8,134

     

     

    26,654

     

     

    21,984

     

    Cost of sales - intangible asset amortization

     

    1,343

     

     

    1,212

     

     

    3,834

     

     

    3,549

     

    Research and development

     

    62,902

     

     

    77,896

     

     

    201,000

     

     

    210,674

     

    Selling, general and administrative

     

    38,636

     

     

    41,811

     

     

    123,136

     

     

    137,601

     

    Acquired in-process research and development

     

    -

     

     

    9,440

     

     

    -

     

     

    9,440

     

    Other operating expenses

     

    -

     

     

    5,539

     

     

    3,805

     

     

    5,539

     

    Total expenses

     

    111,319

     

     

    144,032

     

     

    358,429

     

     

    388,787

     

     
    Operating loss

     

    (72,547

    )

     

    (106,429

    )

     

    (237,206

    )

     

    (285,088

    )

     
    Other income (expense):
    Interest expense

     

    (6,859

    )

     

    (5,278

    )

     

    (23,160

    )

     

    (12,684

    )

    Foreign currency gain (loss)

     

    633

     

     

    (229

    )

     

    (102

    )

     

    (648

    )

    Gain on extinguishment of debt

     

    -

     

     

    18,480

     

     

    -

     

     

    18,480

     

    Loss on convertible senior notes conversion

     

    -

     

     

    -

     

     

    (7,791

    )

     

    -

     

    Loss on extinguishment of debt

     

    -

     

     

    -

     

     

    (3,277

    )

     

    -

     

    Legal settlement loss

     

    -

     

     

    (1,750

    )

     

    -

     

     

    (26,750

    )

    Other income

     

    79

     

     

    781

     

     

    1,160

     

     

    5,081

     

    Other income (expense), net

     

    (6,147

    )

     

    12,004

     

     

    (33,170

    )

     

    (16,521

    )

     
    Loss before income taxes

     

    (78,694

    )

     

    (94,425

    )

     

    (270,376

    )

     

    (301,609

    )

    Income tax benefit

     

    18

     

     

    350

     

     

    122

     

     

    686

     

    Net loss

    $

    (78,676

    )

    $

    (94,075

    )

    $

    (270,254

    )

    $

    (300,923

    )

     
    Basic and diluted net loss per common share

    $

    (0.89

    )

    $

    (1.72

    )

    $

    (3.37

    )

    $

    (5.62

    )

     
    Basic and diluted weighted-average common shares

     

    88,255

     

     

    54,707

     

     

    80,153

     

     

    53,549

     

    CONSOLIDATED BALANCE SHEET DATA
    (Unaudited, in thousands)
     
    September 30, 2020 Dec 31, 2019
     
    Cash and cash equivalents

    $

    224,702

     

    $

    161,833

     

    Available-for-sale securities

     

    -

     

     

    134,826

     

    Working capital

     

    165,321

     

     

    233,384

     

    Total assets

     

    593,057

     

     

    669,604

     

    Convertible senior notes

     

    505,278

     

     

    644,751

     

    Common stock and additional paid-in capital

     

    2,395,063

     

     

    2,114,123

     

    Total stockholders' deficit

     

    (163,366

    )

     

    (174,257

    )

     
    Other Data
    (Unaudited, in thousands)
    Nine Months Ended September 30,

     

    2020

     

     

    2019

     

     
    Net cash used in operating activities

     

    (196,675

    )

     

    (253,468

    )

     
    Share Based Compensation Expense

     

    38,765

     

     

    41,748

     

    RECONCILIATION OF NET CASH USED IN OPERATING
    ACTIVITIES TO CASH BURN
    (Unaudited, in thousands)
     

    Three Months Ended

    September 30, 2020

    Nine Months Ended

    September 30, 2020

     
     
    Net cash used in operating activities

    $

    (54,324

    )

    $

    (196,675

    )

    Adjustments:
    Acquired in-process research and development - milestone payment

     

    -

     

     

    (8,000

    )

    Proceeds from borrowings under financing agreement

     

    16,641

     

     

    49,963

     

    Cash burn

    $

    (37,683

    )

    $

    (154,712

    )

     
    Net cash (used in) provided by investing activities

    $

    (19

    )

    $

    126,588

     

     
    Net cash provided by financing activities

    $

    16,157

     

    $

    131,808

     

    To supplement our financial statements prepared in accordance with U. S. GAAP, we monitor and consider cash burn, which is a non-U.S. GAAP financial measure. This non-U.S. GAAP financial measure is not based on any standardized methodology prescribed by U.S. GAAP and is not necessarily comparable to similarly-titled measures presented by other companies. We define cash burn as net cash used in operating activities plus acquired in-process research and development - milestone payments less proceeds from borrowings under financing agreement with TPG specifically related to our Phase 3 ATHENA trial. We believe cash burn to be a liquidity measure that provides useful information to management and investors about the amount of cash consumed by the operations of the business including milestone payments and proceeds from borrowings under the TPG financing agreement, which specifically offsets the costs of our ATHENA trial. A limitation of using this non-U.S. GAAP measure is that cash burn does not represent the total change in cash and cash equivalents for the period because it excludes all other cash provided by or used for other investing and financing activities. We account for this limitation by providing information about our investing and financing activities in the statements of cash flows in our financial statements and by presenting cash flows from investing and financing activities in our reconciliation of cash burn. In addition, it is important to note that other companies, including companies in our industry, may not use cash burn, may calculate cash burn in a different manner than we do or may use other financial measures to evaluate their performance, all of which could reduce the usefulness of cash burn as a comparative measure. Because of these limitations, cash burn should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with U.S. GAAP.

     

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  5. Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that on November 4, 2020 it entered into a privately negotiated exchange and purchase agreement (the "Agreement") with a holder of its currently outstanding 4.50% Convertible Senior Notes due 2024 (the "Existing 2024 Notes"). Pursuant to the Agreement, in exchange for $64,842,000 aggregate principal amount of Existing 2024 Notes held by the holder (which is currently convertible into approximately 8.9 million shares of common stock), Clovis Oncology has agreed to issue to the holder a number of shares of the Company's common stock (the "Exchanged Shares") utilizing an exchange ratio that is based in part on the daily volume-weighted average prices ("VWAPs") per share of Clovis Oncology's common…

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that on November 4, 2020 it entered into a privately negotiated exchange and purchase agreement (the "Agreement") with a holder of its currently outstanding 4.50% Convertible Senior Notes due 2024 (the "Existing 2024 Notes"). Pursuant to the Agreement, in exchange for $64,842,000 aggregate principal amount of Existing 2024 Notes held by the holder (which is currently convertible into approximately 8.9 million shares of common stock), Clovis Oncology has agreed to issue to the holder a number of shares of the Company's common stock (the "Exchanged Shares") utilizing an exchange ratio that is based in part on the daily volume-weighted average prices ("VWAPs") per share of Clovis Oncology's common stock during a seven-trading day pricing period following execution of the Agreement.

    In addition, pursuant to the Agreement, Clovis Oncology has also agreed to sell to the holder $50,000,000 aggregate principal amount of a new series of 4.50% Convertible Senior Notes due 2024 (the "New 2024 Notes") at a purchase price of $1,000 per $1,000 principal amount thereof. Also, Clovis Oncology has granted the holder a 13-day option to purchase up to an additional $20,000,000 aggregate principal amount of New 2024 Notes on the same terms and conditions.

    About the Debt Exchange

    The number of Exchanged Shares to be issued by Clovis Oncology to the holder will be calculated utilizing an exchange ratio that is based in part on the average VWAPs of Clovis Oncology's common stock (subject to a floor) during a seven-trading day pricing period beginning on November 5, 2020 and ending on, and including, November 13, 2020. Assuming such average VWAP is $5.67 per share, which is the last reported sale price of Clovis Oncology's common stock on the Nasdaq Global Select Market on November 4, 2020, 13,038,683 Exchanged Shares would be issuable pursuant to the debt exchange transaction. However, in the event that Clovis Oncology's stock price declines during the pricing period, Clovis Oncology will be required to issue more shares, but in no event more than 15,696,240 Exchanged Shares are issuable pursuant to the debt exchange transaction.

    About the New 2024 Notes

    The New 2024 Notes will bear interest at a rate of 4.50% per annum, payable semi-annually in arrears on February 1st and August 1st of each year. The New 2024 Notes will mature on August 1, 2024 unless earlier converted or repurchased. The holders of the New 2024 Notes may convert their notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date at an initial conversion rate of 160.3334 shares of Clovis Oncology's common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of approximately $6.24 per share of common stock. The initial conversion price of the notes represents a premium of approximately 10% to the last reported sale price, $5.67 per share, of Clovis Oncology's common stock on November 4, 2020.

    Clovis Oncology will not have the right to redeem the New 2024 Notes prior to their maturity. Holders of the New 2024 Notes may require Clovis Oncology to repurchase for cash all or part of their notes upon certain fundamental changes at a repurchase price equal to 100% of the principal amount of the New 2024 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date, Clovis Oncology will, in certain circumstances, increase the conversion rate for a holder who elects to convert its New 2024 Notes in connection with such corporate event.

    The above summary of the terms of the New 2024 Notes is qualified in its entirety by and should be read with the Indenture governing the New 2024 Notes, the form of which is anticipated to be filed with the Securities and Exchange Commission on or about November 5, 2020.

    Clovis Oncology intends to use the net proceeds from the sale of the New 2024 Notes for general corporate purposes, including repayment, repurchase or refinance of its debt obligations, sales and marketing expenses associated with Rubraca® (rucaparib), funding of its development programs, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

    The issuance of the Exchanged Shares, the New 2024 Notes in the transaction and any shares of common stock issuable upon conversion of such New 2024 Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law, and, unless so registered, the New 2024 Notes and any such shares may not be offered or sold in the United States except pursuant to an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Clovis Oncology has agreed to file a registration statement for the resale of the shares of common stock issuable upon the conversion of the New 2024 Notes purchased by the holder. This press release does not constitute an offer to sell, or a solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering would be unlawful.

    About the Settlement of the Transactions

    The exchange and purchase transaction will settle in two parts. Approximately 8.9 million of the Exchanged Shares are expected to be issued on or about November 6, 2020 and the remainder will be issued within two business days following the seven-trading day pricing period and the final calculation of the exchange ratio, which is expected to occur on or about November 17, 2020. The sale of the New 2024 Notes is expected to occur on or about November 17, 2020. In each case, the settlement of the exchange and purchase transaction is subject to the satisfaction of customary closing conditions.

    J.P. Morgan and BofA Securities acted as structuring banks to Clovis Oncology in connection with the transactions.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado with additional office locations in the U.S. and Europe.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Such forward-looking statements involve substantial risks and uncertainties that could cause Clovis Oncology's actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the conditions affecting the capital markets, general economic, industry, or political conditions, and the satisfaction of customary closing conditions related to the proposed exchange and purchase transaction. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its other reports filed with the Securities and Exchange Commission.

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  6. Clovis Oncology, Inc. (NASDAQ:CLVS) will announce its third quarter 2020 financial results on Thursday, November 5, 2020, before the open of the U.S. financial markets. Clovis' senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the company's results in greater detail.

    The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

    Conference Call Details

    Clovis will hold a conference call to discuss third quarter 2020 results on Thursday, November 5 at 8:30 a.m. ET. The conference call will be simultaneously webcast on the Company's web site at www.clovisoncology.com, and archived for future…

    Clovis Oncology, Inc. (NASDAQ:CLVS) will announce its third quarter 2020 financial results on Thursday, November 5, 2020, before the open of the U.S. financial markets. Clovis' senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the company's results in greater detail.

    The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

    Conference Call Details

    Clovis will hold a conference call to discuss third quarter 2020 results on Thursday, November 5 at 8:30 a.m. ET. The conference call will be simultaneously webcast on the Company's web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: U.S. participants (877) 698-7048, International participants (647) 689-5448, conference ID: 2999168.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado; please visit www.clovisoncology.com for more information, including additional office locations in the U.S. and Europe.

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    • Initial data from the Phase 1b part of the LIO-1 trial of lucitanib combined with Opdivo® (nivolumab) in advanced metastatic solid tumors identify a recommended Phase 2 dose and show promising signs of antitumor activity
    • The first presentation of preclinical data for FAP-2286, a novel peptide-targeted radionuclide therapy (PTRT), show the compound potently and selectively binds fibroblast activation protein (FAP); compelling anti-tumor activity was observed in FAP-expressing tumor models
    • New data analyses from pivotal Rubraca® (rucaparib) studies ARIEL3 and TRITON2 further characterize its safety profile in recurrent ovarian cancer and metastatic castration-resistant prostate cancer (mCRPC), respectively
    • Encouraging initial data from
    • Initial data from the Phase 1b part of the LIO-1 trial of lucitanib combined with Opdivo® (nivolumab) in advanced metastatic solid tumors identify a recommended Phase 2 dose and show promising signs of antitumor activity
    • The first presentation of preclinical data for FAP-2286, a novel peptide-targeted radionuclide therapy (PTRT), show the compound potently and selectively binds fibroblast activation protein (FAP); compelling anti-tumor activity was observed in FAP-expressing tumor models
    • New data analyses from pivotal Rubraca® (rucaparib) studies ARIEL3 and TRITON2 further characterize its safety profile in recurrent ovarian cancer and metastatic castration-resistant prostate cancer (mCRPC), respectively
    • Encouraging initial data from the SEASTAR study evaluating Rubraca in combination

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced the data being presented as e-posters at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. These include initial data from the Phase 1b part of the LIO-1 study of lucitanib in combination with Opdivo, new analyses of data from the pivotal Rubraca ARIEL3 and TRITON2 studies, initial data from the Phase 1b part of the SEASTAR study arm of Rubraca with Trodelvy™ (sacituzumab govitecan-hziy), and the first presentation of preclinical data for FAP-2286 Clovis' novel peptide-targeted radionuclide therapy.

    "We are very pleased to present these encouraging initial datasets for our pipeline compounds lucitanib and FAP-2286 today, as well as data further characterizing and confirming the established safety profile of Rubraca in advanced ovarian and prostate cancers, which we believe provides additional, valuable information to physicians and their patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are enthusiastic about the potential of our clinical development programs for each of our three compounds and remain committed to exploring the full depth and breadth of our pipeline to transform the cancer treatment landscape and hopefully improve outcomes for patients."

    Data presented today from the Phase 1b part of the Phase 1b/2 LIO-1 study in patients with an advanced solid tumor (n=17) have identified the recommended starting Phase 2 dose of oral lucitanib to be used in combination with Opdivo and have shown promising signs of antitumor activity. The recommended oral starting dose of lucitanib was established as 6 mg once daily, to be given in combination with Opdivo at a fixed dose of 480 mg intravenously (IV) once every 28 days. Across three dose levels studied (6 mg, 8 mg and 10 mg) of oral lucitanib in combination with intravenous (IV) Opdivo at (480 mg once every 28 days), only one dose-limiting toxicity of Grade 3 proteinuria was observed among 17 patients, and there were no apparent differences in treatment-emergent adverse event (TEAE) frequencies between dose levels. In this small patient population, TEAEs were consistent with those expected for lucitanib and Opdivo. Grade 3 TEAEs included hypertension (n=4), diarrhea (n=1), and proteinuria (n=1); treatment-emergent hypertension was otherwise grade 1 or 2 (n=4), and readily managed with close monitoring and early hypertensive therapy. No grade ≥4 adverse events were reported. Given lucitanib's relatively large inter-patient pharmacokinetic variability, a safety-based dose-titration approach is being used for the Phase 2 part of the study to optimize lucitanib efficacy as well as safety and tolerability. Among the 17 patients treated, 15 were evaluable for RECIST response as of the efficacy cut-off date: these include one patient with a confirmed complete response, one patient with a confirmed partial response, 10 patients have had a best response of stable disease and three patients had progressive disease. As of August 11, 2020, seven of the 17 patients remained on study, including the two responders and five of the patients with stable disease.

    "We have completed enrollment in the Phase 1b part of the LIO-1 trial, and have identified a dose of lucitanib to take into Phase 2 combined with nivolumab. The combination showed promising signs of activity in unselected solid tumors in patients with very advanced disease, including one patient with a confirmed complete response," said Dr. Erika Hamilton, Director of the Breast and Gynecologic Research Program, Sarah Cannon Research Institute at Tennessee Oncology. "We were also encouraged by the initial safety profile, in particular as it relates to constitutional side effects, and hope to build on that with our dose-titration approach in the ongoing Phase 2 part of the LIO-1 study. This will provide greater understanding of what this combination may offer for the treatment of patients with gynecological cancers."

    In addition to data from the Phase 1b part of the LIO-1 study, a Trials in Progress (TiP) poster describing the study design of the Phase 2 part of LIO-1 was presented. The Phase 2 part of the study is currently enrolling patients to evaluate the efficacy and safety of the lucitanib and Opdivo combination in patients with advanced gynecological solid tumors, including ovarian, endometrial and cervical cancers. As described in the e-poster, a safety-based dose-titration approach is being used for lucitanib dosing to manage tolerability and maintain dose intensity.

    Investigators also presented today new safety data analyses from the pivotal Rubraca studies ARIEL3 and pharmacokinetic (PK) analyses of TRITON2, providing additional information to healthcare professionals that can help support their ovarian and prostate cancer patients being treated with Rubraca.

    The ARIEL3 data presented in an e-poster reinforce the overall safety profile of Rubraca as a maintenance treatment in patients with recurrent ovarian cancer. After two years of additional follow up for those patients who continued on treatment in the study, the safety profile remains consistent with previous reports, with no new safety signals identified. As of the current safety data cutoff (December 31, 2019), 33 of 372 and 1 of 189 patients in the safety population were still receiving Rubraca or placebo, respectively. Median treatment duration was 8.3 months in the Rubraca arm and 5.5 months in the placebo arm. Prevalence of any-grade nausea declined progressively over the 24-month evaluation period, and prevalence of any-grade anemia/decreased hemoglobin peaked at month 4, decreasing to a plateau after month 8. The first onset of frequently reported TEAEs generally occurred early in treatment (≤45 days). The median duration of the first event of frequently reported TEAEs was generally <60 days.

    Population pharmacokinetic (PK) analyses of 199 men with mCRPC receiving Rubraca in the TRITON2 study suggest there is no difference in Rubraca PK in men with mCRPC and women with ovarian cancer based on a comparison to a previously-developed model that used data from 454 women with ovarian cancer treated with Rubraca. The data in men with mCRPC show that differences among patients in the amount of Rubraca in the blood after administration of Rubraca at a dose of 600 mg twice daily did not appear to impact the efficacy of treatment. Also, a higher maximum concentration of Rubraca in the blood was not associated with increased rates of most safety endpoints analyzed, including hematologic adverse events. These PK data and exposure and safety/efficacy correlations using data from the TRITON2 study support the use of Rubraca in eligible mCRPC patients with a starting dose of 600 mg twice daily. TRITON2 served as the pivotal data supporting the May 2020 FDA approval of Rubraca as the first PARP inhibitor for patients with advanced mCRPC associated with a BRCA mutation.

    Investigators also presented in an e-poster initial data from the arm of the Phase 1b/2 SEASTAR study evaluating Rubraca in combination with Trodelvy in patients with advanced solid tumors (n=6). Data from the Phase 1b part of the study suggest encouraging initial antitumor activity for the novel combination, including patients with prior PARP inhibitor exposure and without a deleterious homologous recombination repair gene mutation. Despite early toxicities, including dose-limiting neutropenia in two of the three patients in the higher dose cohort, all six patients continued treatment for at least 12 weeks, with side effects effectively managed with dose modification and/or growth factor support. One patient remained on treatment as of the August 11, 2020 data cut-off date. All patients had a best response of stable disease or better, including three patients with a confirmed partial response (all three had been previously treated with a PARP inhibitor).

    And finally, the first data from a preclinical evaluation of FAP-2286, Clovis' novel peptide-targeted radionuclide therapy to fibroblast activation protein (FAP) were presented in an e-poster. The data show that FAP-2286 potently and selectively binds FAP. FAP is highly expressed in cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers and, in some cancers, its expression has also been observed in the tumor cells. Compelling anti-tumor activity was observed with 177Lu-FAP-2286 (Lutetium-177 conjugated to FAP-2286 for therapeutic use) in FAP-expressing tumor models. Clovis Oncology plans to submit two Investigational New Drug (IND) applications in late 2020 for use of this novel radionuclide therapy as an imaging and treatment agent, respectively, and the Company has planned clinical studies in a broad spectrum of FAP-positive cancers.

    Each of Clovis Oncology's e-posters described are available online at www.clovisoncology.com/pipeline/scientific-presentations.

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

    Rubraca is an unlicensed medical product outside of the U.S. and Europe

    Rubraca (rucaparib) European Union (EU) authorized use and Important Safety Information

    Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

    Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with ≥2 prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

    Efficacy of Rubraca as treatment for relapsed or progressive epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) has not been investigated in patients who have received prior treatment with a PARP inhibitor. Therefore, use in this patient population is not recommended.

    Summary warnings and precautions:

    Hematological toxicity

    During treatment with Rubraca, events of myelosuppression (anemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8–10 weeks of treatment with Rubraca. These reactions are manageable with routine medical treatment and/or dose adjustment for more severe cases. Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised. Patients should not start Rubraca treatment until they have recovered from hematological toxicities caused by previous chemotherapy (CTCAE grade ≥1).

    Supportive care and institutional guidelines should be implemented for the management of low blood counts for the treatment of anemia and neutropenia. Rubraca should be interrupted or dose reduced according to Table 1 (see Posology and Method of Administration [4.2] of the Summary of Product Characteristics [SPC]) and blood counts monitored weekly until recovery. If the levels have not recovered to CTCAE grade 1 or better after 4 weeks, the patient should be referred to a hematologist for further investigations.

    MDS/AML

    MDS/AML, including cases with fatal outcome, have been reported in patients who received Rubraca. The duration of therapy with Rubraca in patients who developed MDS/AML varied from less than 1 month to approximately 28 months.

    If MDS/AML is suspected, the patient should be referred to a hematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics. If, following investigation for prolonged hematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.

    Photosensitivity

    Photosensitivity has been observed in patients treated with Rubraca. Patients should avoid spending time in direct sunlight because they may burn more easily during Rubraca treatment; when outdoors, patients should wear a hat and protective clothing, and use sunscreen and lip balm with sun protection factor of 50 or greater.

    Gastrointestinal toxicities

    Gastrointestinal toxicities (nausea and vomiting) are frequently reported with Rubraca, and are generally low grade (CTCAE grade 1 or 2), and may be managed with dose reduction (refer to Posology and Method of Administration [4.2], Table 1 of the SPC) or interruption. Antiemetics, such as 5-HT3 antagonists, dexamethasone, aprepitant and fosaprepitant, can be used as treatment for nausea/vomiting and may also be considered for prophylactic (i.e. preventative) use prior to starting Rubraca. It is important to proactively manage these events to avoid prolonged or more severe events of nausea/vomiting which have the potential to lead to complications such as dehydration or hospitalization.

    Embryofetal toxicity

    Rubraca can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. In an animal reproduction study, administration of Rubraca to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see Preclinical Safety Data [5.3] of the SPC).

    Pregnancy/contraception

    Pregnant women should be informed of the potential risk to a fetus. Women of reproductive potential should be advised to use effective contraception during treatment and for 6 months following the last dose of Rubraca (see section 4.6 of the SPC). A pregnancy test before initiating treatment is recommended in women of reproductive potential.

    Click here to access the current SPC. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

    Rubraca U.S. FDA Approved Indications

    Ovarian Cancer

    Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

    Rubraca is indicated for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

    Prostate Cancer

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. For males on Rubraca treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

    Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

    Please click here for full Prescribing Information for Rubraca.

    About Lucitanib

    Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy.

    Lucitanib is an unlicensed medical product.

    About FAP-2286

    FAP-2286 is a preclinical candidate discovered by 3B Pharmaceuticals under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis Oncology is planning to submit an investigational new drug application (IND) for FAP-2286 in the second half of 2020 and conduct the global clinical trials. Clovis Oncology holds U.S. and global rights, excluding Europe.

    FAP-2286 is an unlicensed medical product.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations for submission of regulatory filings, the timing and pace of commencement of and enrollment in our clinical trials, including those being planned or conducted in collaboration with partners, the potential results of such clinical trials, our expectations regarding the suitability of each of Rubraca, lucitanib and FAP-2286 for, and our plans to develop each of Rubraca, lucitanib and FAP-2286 in, additional indications and tumor types, and our expectations regarding the outcomes of early studies or trials supporting further development, both non-clinical and clinical. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates and those of our partners, whether future study results will be consistent with study findings to date, the timing of availability of data from our clinical trials and the initiation, enrollment, timing and results of our planned clinical trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, the risk that additional pre-clinical or clinical studies may not support further development in certain additional indications or tumor types, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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  7. Accepted abstract describes exploratory analysis from ARIEL3 further suggesting the durable clinical benefit of Rubraca maintenance treatment beyond progression for women with platinum-sensitive recurrent ovarian cancer with BRCA1/2 mutations

    Clovis Oncology, Inc. (NASDAQ:CLVS), announced today that an abstract featuring data from an exploratory analysis of the ARIEL3 clinical study evaluating Rubraca® (rucaparib) as maintenance treatment in recurrent ovarian cancer has been accepted for presentation in an oral plenary session at the International Gynecologic Cancer Society (IGCS) Digital Annual Global Meeting taking place September 10–13. The findings of the analysis demonstrate that rucaparib maintenance treatment can lead to a clinically…

    Accepted abstract describes exploratory analysis from ARIEL3 further suggesting the durable clinical benefit of Rubraca maintenance treatment beyond progression for women with platinum-sensitive recurrent ovarian cancer with BRCA1/2 mutations

    Clovis Oncology, Inc. (NASDAQ:CLVS), announced today that an abstract featuring data from an exploratory analysis of the ARIEL3 clinical study evaluating Rubraca® (rucaparib) as maintenance treatment in recurrent ovarian cancer has been accepted for presentation in an oral plenary session at the International Gynecologic Cancer Society (IGCS) Digital Annual Global Meeting taking place September 10–13. The findings of the analysis demonstrate that rucaparib maintenance treatment can lead to a clinically meaningful delay in starting subsequent therapy and lasting clinical benefits in patients with BRCA1- or BRCA2-mutant ovarian cancer.

    "This exploratory analysis examining the subgroup of patients with advanced recurrent ovarian cancer and a BRCA1 or BRCA2 mutation suggest the durability of the clinical benefit of rucaparib maintenance," said Johanne Weberpals M.D., Gynecologic Oncologist, Ottawa Hospital Research Institute. "These data reinforce the potential benefit of rucaparib in this patient population."

    "Together with ARIEL3 results we have previously published and presented, these data highlight the clinical benefit that Rubraca offers as a maintenance therapy for patients with recurrent ovarian cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to sharing these data with the research and medical community at this year's digital IGCS global meeting and continuing the important dialogue around the benefits of Rubraca for the treatment of advanced ovarian cancer."

    Following are details regarding the Rubraca abstract to be presented today at IGCS:

    Abstract Number: IGCS20_1268- Postprogression Efficacy Outcomes from the Phase 3 ARIEL3 Study of Rucaparib in Patients With Platinum-Sensitive Recurrent Ovarian Carcinoma Associated With Either BRCA1 or BRCA2 Mutations

    • Presenting Author: Johanne I. Weberpals, MD
    • Session: Plenary I

    The presentation will take place during the Plenary I session which will be broadcast on Thursday, September 10, 2020 from 14:00-15:00 UTC; the specific presentation time is 14:47-14:54 UTC. In addition, the presentation will be available at https://www.clovisoncology.com/pipeline/scientific-presentations/ following the Plenary I session.

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

    Rubraca is an unlicensed medical product outside of the U.S. and Europe.

    Rubraca® (rucaparib) European Union (EU) authorized use and Important Safety Information

    Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

    Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with ≥2 prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

    Efficacy of Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC has not been investigated in patients who have received prior treatment with a PARP inhibitor. Therefore, use in this patient population is not recommended.

    Summary warnings and precautions:

    Hematological toxicity

    During treatment with Rubraca, events of myelosuppression (anemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8–10 weeks of treatment with Rubraca. These reactions are manageable with routine medical treatment and/or dose adjustment for more severe cases. Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised. Patients should not start Rubraca treatment until they have recovered from hematological toxicities caused by previous chemotherapy (CTCAE grade ≥1).

    Supportive care and institutional guidelines should be implemented for the management of low blood counts for the treatment of anemia and neutropenia. Rubraca should be interrupted or dose reduced according to Table 1 (see Posology and Method of Administration [4.2] of the Summary of Product Characteristics [SPC]) and blood counts monitored weekly until recovery. If the levels have not recovered to CTCAE grade 1 or better after 4 weeks, the patient should be referred to a hematologist for further investigations.

    MDS/AML

    MDS/AML, including cases with fatal outcome, have been reported in patients who received Rubraca. The duration of therapy with Rubraca in patients who developed MDS/AML varied from less than 1 month to approximately 28 months.

    If MDS/AML is suspected, the patient should be referred to a hematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics. If, following investigation for prolonged hematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.

    Photosensitivity

    Photosensitivity has been observed in patients treated with Rubraca. Patients should avoid spending time in direct sunlight because they may burn more easily during Rubraca treatment; when outdoors, patients should wear a hat and protective clothing, and use sunscreen and lip balm with sun protection factor of 50 or greater.

    Gastrointestinal toxicities

    Gastrointestinal toxicities (nausea and vomiting) are frequently reported with Rubraca, and are generally low grade (CTCAE grade 1 or 2), and may be managed with dose reduction (refer to Posology and Method of Administration [4.2], Table 1 of the SPC) or interruption. Antiemetics, such as 5-HT3 antagonists, dexamethasone, aprepitant and fosaprepitant, can be used as treatment for nausea/vomiting and may also be considered for prophylactic (i.e. preventative) use prior to starting Rubraca. It is important to proactively manage these events to avoid prolonged or more severe events of nausea/vomiting which have the potential to lead to complications such as dehydration or hospitalization.

    Embryofetal toxicity

    Rubraca can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. In an animal reproduction study, administration of Rubraca to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see Preclinical Safety Data [5.3] of the SPC).

    Pregnancy/contraception

    Pregnant women should be informed of the potential risk to a fetus. Women of reproductive potential should be advised to use effective contraception during treatment and for 6 months following the last dose of Rubraca (see section 4.6 of the SPC). A pregnancy test before initiating treatment is recommended in women of reproductive potential.

    Click here to access the current SPC. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

    Rubraca U.S. FDA Approved Indications

    Ovarian Cancer

    Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

    Rubraca is indicated for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

    Prostate Cancer

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. For males on Rubraca treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

    Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

    Please click here for full Prescribing Information for Rubraca.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado; please visit www.clovisoncology.com for more information, including additional office locations in the U.S. and Europe.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations for submission of regulatory filings, the timing and pace of commencement of and enrollment in our clinical trials, including those being planned or conducted in collaboration with partners, the potential results of such clinical trials, our expectations regarding the suitability of Rubraca for, and our plans to develop Rubraca in, additional indications and tumor types. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates and those of our partners, whether future study results will be consistent with study findings to date, the timing of availability of data from our clinical trials and the initiation, enrollment, timing and results of our planned clinical trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, the risk that additional pre-clinical or clinical studies may not support further development in certain additional indications or tumor types, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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    • Initial presentation of data from the Phase 1b part of the LIO-1 trial of lucitanib in combination with nivolumab in advanced metastatic solid tumors
    • New data analyses for Rubraca® (rucaparib) from the Phase 2 TRITON2 and Phase 3 ARIEL3 studies in patients with metastatic castration-resistant prostate cancer (mCRPC) and recurrent ovarian cancer, respectively
    • First presentation of preclinical data for FAP-2286, a novel peptide-targeted radionuclide therapy (PTRT) being developed for the treatment of a variety of cancers

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that six e-posters highlighting clinical data from the lucitanib and Rubraca® (rucaparib) clinical development programs, as well as preclinical data for FAP-2286, will…

    • Initial presentation of data from the Phase 1b part of the LIO-1 trial of lucitanib in combination with nivolumab in advanced metastatic solid tumors
    • New data analyses for Rubraca® (rucaparib) from the Phase 2 TRITON2 and Phase 3 ARIEL3 studies in patients with metastatic castration-resistant prostate cancer (mCRPC) and recurrent ovarian cancer, respectively
    • First presentation of preclinical data for FAP-2286, a novel peptide-targeted radionuclide therapy (PTRT) being developed for the treatment of a variety of cancers

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that six e-posters highlighting clinical data from the lucitanib and Rubraca® (rucaparib) clinical development programs, as well as preclinical data for FAP-2286, will be presented at the ESMO (European Society for Medical Oncology) Virtual Congress 2020, September 19 – September 21, 2020.

    E-posters for presentation include the following:

    • Initial data from the Phase 1b part of the LIO-1 study in patients with an advanced metastatic solid tumor, which aimed to determine the recommended Phase 2 starting dose of lucitanib in combination with nivolumab and to provide safety, pharmacokinetic and preliminary efficacy data for the combination.
    • A Trials in Progress e-poster describing the design of the Phase 2 part of the LIO-1 study, which is now enrolling patients, and will evaluate the combination's safety and efficacy in patients with an advanced gynecological solid tumor, including ovarian, endometrial and cervical cancers.
    • Analyses of pharmacokinetics and relationships between exposure and efficacy/safety in patients with metastatic castration-resistant prostate cancer (mCRPC) from the Phase 2 TRITON2 study of Rubraca, the primary analysis of which served as the pivotal data supporting FDA approval of Rubraca as the first poly-ADP ribose polymerase (PARP) inhibitor for patients with advanced mCRPC associated with a BRCA mutation.
    • New analysis of data from the Phase 3 ARIEL3 study evaluating the prevalence, timing, and duration of adverse events for Rubraca maintenance therapy in recurrent ovarian cancer.
    • Initial data from the Phase 1b part of the Phase 1b/2 SEASTAR study arm evaluating Rubraca in combination with sacituzumab govitecan for the treatment of metastatic solid tumors, which aims to evaluate the tolerability and preliminary efficacy for the combination.
    • The first presentation of preclinical data in in vivo and in vitro models for FAP-2286, a novel peptide-targeted radionucleotide therapy (PTRT) and imaging agent for which Clovis intends to file imaging and treatment Investigational New Drug applications to the FDA in late 2020.

    "We have made significant progress in expanding the breadth and depth of our oncology development portfolio, including our pipeline compounds lucitanib and FAP-2286. We are excited to share new data and updates for all three compounds from our clinical and preclinical development programs at this year's ESMO congress," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We remain committed to developing targeted therapies to better serve patients, and believe delivering the right drug to the right patient at the right time represents the future of cancer therapy."

    The following abstracts will be available as e-posters for on-demand viewing on the ESMO website at 9:00 a.m. CEST on Thursday, September 17, 2020. The e-posters will also be available online at www.clovisoncology.com/pipeline/scientific-presentations once they are made available during the congress.

    Lucitanib

    E-poster Number 556P: Initial Clinical Experience of Lucitanib + Nivolumab in Advanced Metastatic Solid Tumours: Data From the Phase 1b/2 LIO-1 Study (CO-3810-101; NCT04042116)

    Lead author: Dr. Erika Hamilton, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, United States of America

    E-poster Number 885TiP: LIO-1: A Phase 2 Study of Lucitanib + Nivolumab in Patients (pts) With Gynecological Tumours (CO-3810-101; NCT04042116; ENGOT-GYN3/AGO/LIO)

    Lead author: Prof. Nicole Concin, Kliniken Essen-Mitte, Essen, Germany, and Medizinische Universität Innsbruck, Austria

    Rucaparib

    E-poster Number 659P: Rucaparib Population Pharmacokinetics (PPK) and Exposure-Response (ER) Analyses in Patients (pts) With Metastatic Castration-Resistant Prostate Cancer (mCRPC) in TRITON2

    Lead author: Dr. Simon Chowdhury, Guy's Hospital, London and Sarah Cannon Research Institute, London, United Kingdom

    E-poster Number 821P: Timing of Adverse Events During Maintenance Treatment With Rucaparib for Recurrent Ovarian Cancer in the Phase 3 ARIEL3 Study

    Lead author: Dr. Andrew Dean, St John of God Subiaco Hospital, Subiaco, Australia

    E-poster Number 547P: Rucaparib + Sacituzumab Govitecan (SG): Initial Data From the Phase 1b/2 SEASTAR Study (NCT03992131)

    Lead author: Dr. Timothy A. Yap, The University of Texas MD Anderson Cancer Center, Houston, United States of America

    FAP-2286

    E-poster Number 571P: Preclinical Evaluation of FAP-2286, a Peptide-targeted Radionuclide Therapy (PTRT) to Fibroblast Activation Protein Alpha (FAP)

    Lead author: Dr. Dirk Zboralski, 3B Pharmaceuticals GmbH, Berlin, Germany

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

    Rubraca is an unlicensed medical product outside of the U.S. and Europe.

    Rubraca (rucaparib) European Union (EU) authorized use and Important Safety Information

    Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

    Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with ≥2 prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

    Efficacy of Rubraca as treatment for relapsed or progressive epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) has not been investigated in patients who have received prior treatment with a PARP inhibitor. Therefore, use in this patient population is not recommended.

    Summary warnings and precautions:

    Hematological toxicity

    During treatment with Rubraca, events of myelosuppression (anemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8–10 weeks of treatment with Rubraca. These reactions are manageable with routine medical treatment and/or dose adjustment for more severe cases. Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised. Patients should not start Rubraca treatment until they have recovered from hematological toxicities caused by previous chemotherapy (CTCAE grade ≥1).

    Supportive care and institutional guidelines should be implemented for the management of low blood counts for the treatment of anemia and neutropenia. Rubraca should be interrupted or dose reduced according to Table 1 (see Posology and Method of Administration [4.2] of the Summary of Product Characteristics [SPC]) and blood counts monitored weekly until recovery. If the levels have not recovered to CTCAE grade 1 or better after 4 weeks, the patient should be referred to a hematologist for further investigations.

    MDS/AML

    MDS/AML, including cases with fatal outcome, have been reported in patients who received Rubraca. The duration of therapy with Rubraca in patients who developed MDS/AML varied from less than 1 month to approximately 28 months.

    If MDS/AML is suspected, the patient should be referred to a hematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics. If, following investigation for prolonged hematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.

    Photosensitivity

    Photosensitivity has been observed in patients treated with Rubraca. Patients should avoid spending time in direct sunlight because they may burn more easily during Rubraca treatment; when outdoors, patients should wear a hat and protective clothing, and use sunscreen and lip balm with sun protection factor of 50 or greater.

    Gastrointestinal toxicities

    Gastrointestinal toxicities (nausea and vomiting) are frequently reported with Rubraca, and are generally low grade (CTCAE grade 1 or 2), and may be managed with dose reduction (refer to Posology and Method of Administration [4.2], Table 1 of the SPC) or interruption. Antiemetics, such as 5-HT3 antagonists, dexamethasone, aprepitant and fosaprepitant, can be used as treatment for nausea/vomiting and may also be considered for prophylactic (i.e. preventative) use prior to starting Rubraca. It is important to proactively manage these events to avoid prolonged or more severe events of nausea/vomiting which have the potential to lead to complications such as dehydration or hospitalization.

    Embryofetal toxicity

    Rubraca can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. In an animal reproduction study, administration of Rubraca to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see Preclinical Safety Data [5.3] of the SPC).

    Pregnancy/contraception

    Pregnant women should be informed of the potential risk to a fetus. Women of reproductive potential should be advised to use effective contraception during treatment and for 6 months following the last dose of Rubraca (see section 4.6 of the SPC). A pregnancy test before initiating treatment is recommended in women of reproductive potential.

    Click here to access the current SPC. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

    Rubraca U.S. FDA Approved Indications

    Ovarian Cancer

    Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

    Rubraca is indicated for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

    Prostate Cancer

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. For males on Rubraca treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

    Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

    Please click here for full Prescribing Information for Rubraca.

    About Lucitanib

    Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy.

    Lucitanib is an unlicensed medical product.

    About FAP-2286

    FAP-2286 is a preclinical candidate discovered by 3B Pharmaceuticals under investigation as a PTRT and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis is planning to submit an investigational new drug application (IND) for FAP-2286 in the second half of 2020. Clovis will conduct the global clinical trials and holds U.S. and global rights, excluding Europe.

    FAP-2286 is an unlicensed medical product.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, whether future study results will be consistent with study findings to date and whether future study results will support continued development or regulatory approval. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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  8. Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that its President and Chief Executive Officer, Patrick J. Mahaffy, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16, 2020 at 2:00 p.m. Eastern time.

    This conference is virtual and a live webcast of the presentation can be accessed through the investor relations section of the Company's website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company's website for 30 days.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international…

    Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that its President and Chief Executive Officer, Patrick J. Mahaffy, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16, 2020 at 2:00 p.m. Eastern time.

    This conference is virtual and a live webcast of the presentation can be accessed through the investor relations section of the Company's website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company's website for 30 days.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado; please visit www.clovisoncology.com for more information, including additional office locations in the U.S. and Europe.

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  9. FDA-approved plasma-based companion diagnostic provides advantages for patients and practices

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that the U.S. Food and Drug Administration (FDA) approved the FoundationOne® Liquid CDx, Foundation Medicine's comprehensive liquid biopsy test for all solid tumors with multiple companion diagnostic indications, including for Rubraca ® (rucaparib) tablets, recently approved for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.i,ii FoundationOne Liquid CDx is intended for use by health care professionals…

    FDA-approved plasma-based companion diagnostic provides advantages for patients and practices

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that the U.S. Food and Drug Administration (FDA) approved the FoundationOne® Liquid CDx, Foundation Medicine's comprehensive liquid biopsy test for all solid tumors with multiple companion diagnostic indications, including for Rubraca ® (rucaparib) tablets, recently approved for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.i,ii FoundationOne Liquid CDx is intended for use by health care professionals to help inform cancer treatment decisions in accordance with FDA-approved labeling and professional guidelines for patients with solid tumors.

    FoundationOne Liquid CDx is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies, including Rubraca, the first PARP inhibitor approved for the treatment of BRCA1/2-mutant mCRPC.

    "Tumors with BRCA mutations are by far the most responsive to PARP inhibitors in metastatic castration-resistant prostate cancer, and when we started development of Rubraca for mCRPC, we knew it was important to develop a plasma-based companion diagnostic for physician and patient ease of use," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "What we could not have foreseen was how important a plasma-based test would be in this COVID-19 environment, in which even important procedures, such as tissue-based biopsies, can be difficult to schedule for patients. We are pleased that the FDA has approved a plasma-based companion diagnostic to identify mCRPC patients who may benefit from treatment with Rubraca."

    The objective response rate in BRCA positive patients as determined by FoundationOne Liquid CDx was 46% (95% CI, 31-63), comparable to 44% (95% CI, 31-57) as determined by clinical trial assays for patients enrolled in TRITON2, highlighting the utility and consistency of using a liquid biopsy test for patient selection.i,iii

    "Now that we have drugs that specifically benefit patients with BRCA mutations, the ability to identify who has these mutations is paramount," said Professor Celestia S. Higano, MD FACP, University of Washington School of Medicine. "In contrast to tissue biopsy, a liquid biopsy is a blood-plasma test that is less invasive than a tissue biopsy for assessing germline or somatic BRCA mutations. The FDA's approval of liquid biopsy tests represents a significant advancement for clinicians and patients to make timely decisions about treatment options."

    Foundation Medicine expects the FoundationOne Liquid CDx to be commercially available on Friday, August 28, 2020.

    About Prostate Cancer

    The American Cancer Society estimates that nearly 192,000 men in the United States will be diagnosed with prostate cancer in 2020iv, and the GLOBOCAN Cancer Fact Sheets estimated that approximately 450,000 men in Europe were diagnosed with prostate cancer in 2018.v Castration-resistant prostate cancer has a high likelihood of developing metastases. Metastatic castration-resistant prostate cancer, or mCRPC, is an incurable disease, usually associated with poor prognosis. Approximately 43,000 men in the U.S. are expected to be diagnosed with mCRPC in 2020.vi According to the American Cancer Society, the five-year survival rate for mCRPC is approximately 30 percent.vii Approximately 12 percent of patients with mCRPC harbor a deleterious germline and/or somatic mutation in the genes BRCA1 and BRCA2. These molecular markers may be used to select patients for treatment with a PARP inhibitor.viii

    Rubraca U.S. FDA Approved Indication

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

    This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Click here for full Prescribing Information for Rubraca.

    You may also report side effects to Clovis Oncology, Inc. at 1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US toll-free).

    About Accessing Rubraca

    Rubraca is available in the United States through specialty pharmacies and distributors. Clovis is committed to ensuring Rubraca access for patients and offers eligible patients financial and reimbursement support through Rubraca Connections. More information about Rubraca Connections is available at RubracaConnections.com or by calling 1-844-779-7707 between 8 a.m. and 8 p.m. Eastern Time, Monday through Friday.

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    About FoundationOne Liquid CDx

    FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if available. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

    This press release contains forward-looking statements (as defined under the Private Securities Litigation Reform Act of 1995) about the potential of Rubraca® (rucaparib) for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy, and reflects Clovis Oncology's current beliefs. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. In particular, there are no guarantees that future study results and patient experience will be consistent with the study findings to date, that Rubraca will receive regulatory approval for any future indications, or that it will prove to be commercially successful. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K. All forward-looking statements are based on information currently available to the company, and Clovis Oncology does not undertake to update or revise any forward-looking statements.

    Rubraca® is a registered trademark of Clovis Oncology, Inc.

    Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

    __________________

    i
    Rubraca [package insert]. Boulder, CO; Clovis Oncology. 2020.

    ii Foundation Medicine Inc. news release dated August 26, 2020. FDA Approves Foundation Medicine's FoundationOne® Liquid CDx, a Comprehensive Pan-Tumor Liquid Biopsy Test with Multiple Companion Diagnostic Indications for Patients with Advanced Cancer.

    iii Data on file. Clovis Oncology; Boulder, CO.

    iv American Cancer Society. Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed January 30, 2020.

    v GLOBOCAN Cancer Fact Sheets: prostate cancer. Prostate Cancer Estimated Incidence, Mortality and Prevalence Worldwide in 2018. https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf. Accessed February 4, 2020.

    vi Cameron A. Wade and Natasha Kyprianou. Profiling Prostate Cancer Therapeutic Resistance. International Journal of Molecular Sciences. 2018, 19, 204. https://www.mdpi.com/1422-0067/19/3/904/pdf.

    vii American Cancer Society. Survival rates for prostate cancer. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html. Accessed February 4, 2020.

    viii Abida W, Armenia J, Gopalan A, et al. Prospective Genomic Profiling of Prostate Cancer Across Disease States Reveals Germline and Somatic Alterations That May Affect Clinical Decision Making. JCO Precis Oncol 2017: 1-16.

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  10. Clovis Oncology, Inc. (NASDAQ:CLVS), announced today that data from the Phase 2 TRITON2 study of Rubraca® (rucaparib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/2 mutations were published online in the Journal of Clinical Oncology. These results supported the May 2020 U.S. Food and Drug Administration (FDA) accelerated approval of Rubraca for the treatment of mCRPC patients who have a deleterious BRCA mutation (germline and/or somatic) and who have previously received androgen receptor-directed therapy and taxane-based chemotherapy.

    "Through publication in this prestigious journal, we are pleased to be able to share more detail about this important study, which we believe will be helpful for…

    Clovis Oncology, Inc. (NASDAQ:CLVS), announced today that data from the Phase 2 TRITON2 study of Rubraca® (rucaparib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/2 mutations were published online in the Journal of Clinical Oncology. These results supported the May 2020 U.S. Food and Drug Administration (FDA) accelerated approval of Rubraca for the treatment of mCRPC patients who have a deleterious BRCA mutation (germline and/or somatic) and who have previously received androgen receptor-directed therapy and taxane-based chemotherapy.

    "Through publication in this prestigious journal, we are pleased to be able to share more detail about this important study, which we believe will be helpful for physicians as they consider treatment options for their mCRPC patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The TRITON2 data underscore Rubraca's role as a meaningful new treatment option for men with mCRPC and a deleterious germline or somatic BRCA mutation who have progressed on androgen receptor-directed therapy and taxane-based chemotherapy."

    The publication, titled Rucaparib in Men with Metastatic Castration-resistant Prostate Cancer Harboring a BRCA1 or BRCA2 Gene Alteration, is available online at https://ascopubs.org/journal/jco/ and can be accessed by clicking here.

    "PARP inhibitors have been a welcome additional treatment option available for eligible mCRPC patients, and I'm pleased that this publication provides additional detail about the potential clinical benefit of Rubraca for patients," said Wassim Abida, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center, and principal investigator for the TRITON2 study. "These additional data presented in this publication provide physicians important information to inform treatment decisions for their eligible patients."

    Dr. Abida has provided advisory services for Clovis.

    About Rubraca (rucaparib)

    Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

    Rubraca is an unlicensed medical product outside of the U.S. and Europe.

    Rubraca U.S. FDA Approved mCRPC Indication

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

    This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Click here for full Prescribing Information for Rubraca.

    You may also report side effects to Clovis Oncology, Inc. at 1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US toll-free).

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    This press release contains forward-looking statements (as defined under the Private Securities Litigation Reform Act of 1995) about the potential of Rubraca® (rucaparib) for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy, and reflects Clovis Oncology's current beliefs. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. In particular, there are no guarantees that future study results and patient experience will be consistent with the study findings to date, that Rubraca will receive regulatory approval for any future indications, or that it will prove to be commercially successful. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K. All forward-looking statements are based on information currently available to the company, and Clovis Oncology does not undertake to update or revise any forward-looking statements

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    • $39.9M in Rubraca® (rucaparib) global sales for Q2 2020 and $82.5M for H1 2020; net product revenue up 21% over Q2 2019 and 25% over H1 2019
    • $261.4M in cash and cash equivalents at June 30, 2020; anticipated to fund operating plan into early 2022
    • Rubraca approved in the U.S. as monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer (mCRPC) on May 15; virtual U.S. launch in mCRPC underway
    • Completed target enrollment in the Phase 3 ATHENA trial evaluating Rubraca with and without Opdivo® in front-line, newly-diagnosed advanced ovarian cancer
    • Phase 2 portion of LIO-1 combination study of lucitanib and Opdivo in gynecologic cancers now enrolling
    • Investigational New Drug (IND)
    • $39.9M in Rubraca® (rucaparib) global sales for Q2 2020 and $82.5M for H1 2020; net product revenue up 21% over Q2 2019 and 25% over H1 2019
    • $261.4M in cash and cash equivalents at June 30, 2020; anticipated to fund operating plan into early 2022
    • Rubraca approved in the U.S. as monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer (mCRPC) on May 15; virtual U.S. launch in mCRPC underway
    • Completed target enrollment in the Phase 3 ATHENA trial evaluating Rubraca with and without Opdivo® in front-line, newly-diagnosed advanced ovarian cancer
    • Phase 2 portion of LIO-1 combination study of lucitanib and Opdivo in gynecologic cancers now enrolling
    • Investigational New Drug (IND) applications for FAP-2286 as both imaging and treatment agent planned in Q4 2020
    • Data for all three of Clovis Oncology commercial or development-stage products to be presented at the 2020 ESMO Virtual Congress in September

    Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2020, and provided an update on the Company's clinical development programs and regulatory and commercial outlook for the rest of the year.

    "We are pleased with our U.S. approval in advanced prostate cancer and continued sales growth for Rubraca year over year in the U.S. and Europe, particularly in the face of evident headwinds from COVID-19. Second-quarter revenues were negatively affected, largely due to fewer new patient starts, as oncology practices and patients adjusted to the impact of the virus in the U.S. and Europe," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We continue to believe that Rubraca has significant advantages as a maintenance option in ovarian cancer and a treatment option for prostate cancer in an environment in which physicians are trying to reduce patient visits to their clinics, and will continue our efforts to engage with clinicians during this period, which is ongoing as resurgences of the virus continue in large U.S. markets. I am pleased that we successfully completed target enrollment in the 1000 patient Phase 3 ATHENA study in front-line, newly diagnosed advanced ovarian cancer maintenance in June in less than two years. We are also particularly enthusiastic to be moving FAP-2286 into the clinic with planned imaging and therapeutic INDs in the fourth quarter."

    Second Quarter 2020 Financial Results

    Clovis reported net product revenue for Rubraca of $39.9 million for the second quarter of 2020, which included U.S. product revenue of $36.7 million and ex-U.S. product revenue of $3.2 million, compared to net product revenue for Q2 2019 of $33.0 million, which included U.S. net product revenue of $32.7 million and ex-U.S. net product revenue of $0.3 million. U.S. product revenues increased 12 percent in Q2 2020 compared to Q2 2019 and ex-U.S. product revenue increased meaningfully from the first reported ex-U.S. sales in Q2 2019.

    Clovis reported net product revenue for Rubraca of $82.5 million for the six months ended June 30, 2020, which included U.S. product revenue of $76.0 million and ex-U.S. product revenue of $6.5 million, compared to net product revenue for same period in 2019 of $66.1 million, which included U.S. net product revenue of $64.6 million and ex-U.S. net product revenue of $1.5 million.

    Net product revenue decreased six percent sequentially from Q1 2020 to Q2 2020 principally due to reduced new patient starts which we believe is the result of the effects of COVID-19 in the U.S. and Europe during the quarter. The effects of COVID-19 on future sales are difficult to predict, especially with the increase in COVID-19 cases in the U.S. and Europe.

    Clovis had $261.4 million in cash and cash equivalents as of June 30, 2020, including $82.8 million in net proceeds in an equity offering of 11.1 million shares of common stock in May 2020.

    The Company has reduced its total outstanding convertible debt by $145.1 million in outstanding principal amount from December 31, 2019 through June 30, 2020.

    As of June 30, 2020, the Company had drawn approximately $68 million under the TPG ATHENA clinical trial financing and had up to $107 million available to draw under the agreement to fund the expenses of the ATHENA trial through Q3 2022.

    Based on the Company's anticipated revenues, spending, available financing sources and existing cash and cash equivalents, the Company believes it has sufficient cash and cash equivalents to fund its operating plan into early 2022, after taking into account any cash repayment (unless refinanced earlier) of the remaining $64.42 million aggregate principal amount of the 2.50% convertible notes, at their maturity in September 2021.

    Net cash used in operating activities was significantly lower at $59.9 million for the second quarter of 2020, compared with $98.0 million for the second quarter of 2019. Similarly, net cash used in operating activities for the first half of 2020 was $142.4 million, compared with $196.5 million for the first half of 2019.

    Borrowings under the TPG ATHENA financing provided $17.7 million in cash in Q2 2020, and we paid a milestone payment to Pfizer of $8.0 million for the U.S. mCRPC approval. Cash burn in Q2 2020 was $50.1 million, which represents a 25 percent decline from the Q1 2020 cash burn of $66.9 million. Cash burn in the first half of 2020 was $117.0 million.

    Clovis reported a net loss for the second quarter of 2020 of $92.2 million, or ($1.15) per share, and a net loss of $191.6 million, or ($2.52) per share, for the first half of 2020. Net loss for Q2 2019 was $120.4 million, or ($2.27) per share, and $206.9 million, or a net loss of ($3.91) per share, for the first half of 2019. Net loss for Q2 and the first half of 2020 included share-based compensation expense of $13.3 million and $26.3 million, compared to $14.1 million and $27.8 million for the comparable periods of 2019.

    Research and development expenses totaled $69.9 million for Q2 2020 and $138.1 million for the first half of 2020, compared to $70.7 million and $132.8 million for the comparable periods in 2019. Research and development expenses remained relatively flat for the second quarter and increased slightly for the first half of 2020 compared to the same period in the prior year. We expect research and development expenses to be lower in the full year 2021 compared to full year 2020.

    Selling, general and administrative expenses totaled $41.9 million for Q2 2020 and $84.5 million for the first half of 2020, compared to $48.0 million and $95.8 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the second quarter and first half of 2020 compared to the same period in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts.

    U.S. Approval and Label Expansion for Rubraca now includes BRCA1/2-mutant mCRPC

    On May 15, 2020, the U.S. FDA approved Rubraca for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castrate-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this indication under accelerated approval based on objective response rate and duration of response data from the multi-center, single arm TRITON2 clinical trial.

    In late May, the National Comprehensive Cancer Network® (NCCN) updated its Clinical Practice Guidelines in Oncology for Prostate Cancer to include new recommendations for Rubraca. In addition to its ovarian cancer recommendations, Rubraca is now recommended in the NCCN Guidelines® for the treatment of patients with BRCA-mutant tumors with mCRPC under second-line treatment and subsequent therapy as a Category 2A recommendation inclusive of the following:

    Rucaparib is a treatment option for patients with mCRPC and a pathogenic BRCA1 or BRCA2 mutation (germline and/or somatic) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. If the patient is not fit for chemotherapy, rucaparib can be considered even if taxane-based therapy has not been given.

    Target Enrollment Completed in the Phase 3 ATHENA Study

    In June, the Company announced the completion of target enrollment of 1000 patients in the Clovis-sponsored Phase 3 ATHENA trial evaluating Rubraca as monotherapy and the combination of Rubraca and Opdivo as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer. ATHENA is the first front-line switch maintenance study designed to evaluate PARP monotherapy and PARP/PD-1 combination therapy in one study design. Target enrollment of 1000 patients in the ATHENA study was achieved in less than two years with the support and involvement of the Gynecologic Oncology Group (GOG) and the European Network for Gynecological Oncological Trials (ENGOT), two of the largest cooperative groups in the U.S. and Europe dedicated to the treatment of gynecological cancers.

    In addition, three abstracts describing data from rucaparib monotherapy or combination clinical trials were accepted for e-poster presentation at the 2020 ESMO Virtual Congress in September.

    Lucitanib Combination Studies Underway

    Two Clovis-sponsored early Phase 1b/2 lucitanib combination studies are currently underway: LIO-1, evaluating lucitanib and Opdivo in combination in advanced solid tumors (Phase 1b) and gynecologic cancers (Phase 2); and lucitanib in combination with rucaparib in advanced solid tumors (Phase 1b) and ovarian cancer (Phase 2) as an arm of the SEASTAR study. An abstract describing the initial Phase 1b clinical experience of lucitanib in combination with Opdivo (LIO-1) has been accepted as an e-poster for the 2020 European Society of Medical Oncology (ESMO) Virtual Congress to be held in September. In addition, the Phase 2 portion of LIO-1 recently opened for enrollment and treated the first patient in the trial, and a Trials-In-Progress e-poster describing the trial design was also accepted for the 2020 ESMO Virtual Congress.

    FAP-2286 and Peptide-Targeted Radiotherapy Development Program

    The Company's peptide-targeted radiopharmaceutical therapy development program includes lead compound FAP-2286 and three additional unnamed preclinical targets. An abstract describing the first presentation of FAP-2286 preclinical data in animal models has been accepted for the 2020 ESMO Virtual Congress, and during Q4 2020, Clovis intends to submit two Investigational New Drug (IND) applications for FAP-2286 for use as imaging and treatment agents respectively. Upon activation of the INDs by the U.S. FDA, Clovis will initiate a Phase 1 study to determine the dose and tolerability of the FAP-targeting therapeutic agent, with expansion cohorts planned in multiple tumor types. The FAP-targeting imaging agent will be utilized to identify tumors that contain FAP for treatment in the Phase 1 study.

    Conference Call Details

    Clovis will hold a conference call to discuss Q2 2020 results this afternoon, August 6, at 4:30pm ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 7155799.

    About Rubraca (rucaparib)

    Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

    In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Patients should be selected for treatment with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic). This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

    In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

    Rubraca is an unlicensed medical product outside of the U.S. and Europe.

    About Lucitanib

    Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy.

    Lucitanib is an unlicensed medical product.

    About FAP-2286

    FAP-2286 is a preclinical candidate discovered by 3B Pharmaceuticals under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis is planning to submit an investigational new drug application (IND) for FAP-2286 in the second half of 2020. Clovis will conduct the global clinical trials and holds U.S. and global rights, excluding Europe.

    FAP-2286 is an unlicensed medical product.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical second focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our future financial and operating performance, business plans or prospects, including expectations concerning our future cash position, our expectations regarding the impact of COVID-19 on our business operations and results, including future revenues, supply and distribution of our clinical trial supplies and commercial product supplies, our expectations regarding our ability to maintain the enrollment and conduct of our clinical trials and other development activities, expectations concerning future regulatory activities, our plans for commercial launch in expanded indications in the United States, our plans for commercial launch in additional countries, expectations for submission of regulatory filings, our plans to present final or interim data on ongoing clinical trials, our plans to submit additional data to, or meet with, the FDA with respect to the status of or plans for ongoing or planned trials, the timing and pace of commencement of enrollment in and conduct of our clinical trials and the cost of certain trials, including those being considered, planned or conducted in collaboration with partners, our plans for commencement of additional planned trials, the potential results of such clinical trials, changes in drug supply timing and costs and other expenses and statements regarding our expectations of the supply of free drug distributed to eligible patients and our expectations regarding the funding that may be available to us under the agreement with TPG Sixth Street Partners. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the impacts of the COVID-19 pandemic and disruption related to efforts to mitigate its spread on our business, results of operations or financial condition, including impacts on the vendors or distribution channels in our supply chain, impacts on our contract manufacturers' ability to continue to manufacture our products, impacts on our ability to continue our development activities, impacts on the conduct of our clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites or monitoring of data and impact on the ability and timing of our field personnel to conduct their activities with health care providers, the uncertainties inherent in the effect our future revenues or expenses may have on our cash position, the market potential of our approved drug, including the performance of our sales and marketing efforts and the success of competing drugs and therapeutic approaches, changes in gross-to-net or free drug provided through our patient assistance program, the availability of reimbursement and insurance coverage, the performance of our third-party manufacturers, whether our clinical development programs for our drug candidates and those of our partners can be completed on time or at all, whether future study results will be consistent with study findings to date and whether future study results will support continued development or regulatory approval, the corresponding development pathways of our companion diagnostics, the timing of availability of data from our clinical trials and the results, the initiation, enrollment, timing and results of our planned clinical trials, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to accept or approve drug applications that may be filed, their interpretations of our data and agreement with our regulatory approval strategies or components of our filings, including our clinical trial designs, conduct and methodologies, as well as their decisions regarding drug labeling, reimbursement and pricing, and other matters that could affect the development, approval, availability or commercial potential of our drug candidates or companion diagnostics. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

    CLOVIS ONCOLOGY, INC
    CONSOLIDATED FINANCIAL RESULTS
    (Unaudited, in thousands, except per share amounts)
     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

    2020

     

    2019

     

    2020

     

    2019

    Revenues:
    Product revenue

    $

    39,887

     

    $

    32,978

     

    $

    82,451

     

    $

    66,096

     

     
    Operating expenses:
    Cost of sales - product

     

    9,120

     

     

    6,445

     

     

    18,216

     

     

    13,851

     

    Cost of sales - intangible asset amortization

     

    1,280

     

     

    1,217

     

     

    2,492

     

     

    2,337

     

    Research and development

     

    69,878

     

     

    70,746

     

     

    138,099

     

     

    132,777

     

    Selling, general and administrative

     

    41,902

     

     

    48,029

     

     

    84,500

     

     

    95,791

     

    Other operating expenses

     

    355

     

     

    -

     

     

    3,805

     

     

    -

     

    Total expenses

     

    122,535

     

     

    126,437

     

     

    247,112

     

     

    244,756

     

     
    Operating loss

     

    (82,648

    )

     

    (93,459

    )

     

    (164,661

    )

     

    (178,660

    )

     
    Other income (expense):
    Interest expense

     

    (6,739

    )

     

    (3,817

    )

     

    (16,300

    )

     

    (7,407

    )

    Foreign currency loss

     

    142

     

     

    (226

    )

     

    (735

    )

     

    (419

    )

    Loss on convertible notes conversion

     

    -

     

     

    -

     

     

    (7,791

    )

     

    -

     

    Loss on extinguishment of debt

     

    (3,277

    )

     

    -

     

     

    (3,277

    )

     

    -

     

    Legal settlement loss

     

    -

     

     

    (25,000

    )

     

    -

     

     

    (25,000

    )

    Other income

     

    239

     

     

    1,899

     

     

    1,081

     

     

    4,300

     

    Other income (expense), net

     

    (9,635

    )

     

    (27,144

    )

     

    (27,022

    )

     

    (28,526

    )

     
    Loss before income taxes

     

    (92,283

    )

     

    (120,603

    )

     

    (191,683

    )

     

    (207,186

    )

    Income tax benefit

     

    36

     

     

    176

     

     

    104

     

     

    336

     

    Net loss

    $

    (92,247

    )

    $

    (120,427

    )

    $

    (191,579

    )

    $

    (206,850

    )

     
    Basic and diluted net loss per common share

    $

    (1.15

    )

    $

    (2.27

    )

    $

    (2.52

    )

    $

    (3.91

    )

     
    Basic and diluted weighted-average common shares

     

    80,453

     

     

    53,028

     

     

    76,057

     

     

    52,960

     

     
     
    CONSOLIDATED BALANCE SHEET DATA
    (Unaudited, in thousands)
     

    June 30, 2020

    Dec 31, 2019

     
    Cash and cash equivalents

    $

    261,436

     

    $

    161,833

     

    Available-for-sale securities

     

    -

     

     

    134,826

     

    Working capital

     

    210,254

     

     

    233,384

     

    Total assets

     

    628,209

     

     

    669,604

     

    Convertible senior notes

     

    504,680

     

     

    644,751

     

    Common stock and additional paid-in capital

     

    2,382,632

     

     

    2,114,123

     

    Total stockholders' deficit

     

    (97,375

    )

     

    (174,257

    )

     
    Other Data
    (Unaudited, in thousands)

    Six Months Ended June 30,

    2020

    2019

     
    Net cash used in operating activities

     

    (142,351

    )

     

    (196,488

    )

     
    Share Based Compensation Expense

     

    26,274

     

     

    27,769

     

     
     
     
    RECONCILIATION OF NET CASH USED IN OPERATING
    ACTIVITIES TO CASH BURN
    (Unaudited, in thousands)
     

    Three Months

    Ended June 30,

    2020

    Six Months

    Ended June 30,

    2020

     
     
    Net cash used in operating activities

    $

    (59,857

    )

    $

    (142,351

    )

    Adjustments:
    Acquired in-process research and development - milestone payment

     

    (8,000

    )

     

    (8,000

    )

    Proceeds from borrowings under financing agreement

     

    17,730

     

     

    33,322

     

    Cash burn

    $

    (50,127

    )

    $

    (117,029

    )

     
    Net cash provided by investing activities

    $

    56,800

     

    $

    126,607

     

     
    Net cash provided by financing activities

    $

    101,007

     

    $

    115,651

     

     
    To supplement our financial statements prepared in accordance with U.S. GAAP, we monitor and consider cash burn, which is a non-U.S. GAAP financial measure. This non-U.S. GAAP financial measure is not based on any standardized methodology prescribed by U.S. GAAP and is not necessarily comparable to similarly-titled measures presented by other companies. We define cash burn as net cash used in operating activities plus acquired in-process research and development - milestone payments less proceeds from borrowings under financing agreement with TPG specifically related to our Phase 3 ATHENA trial. We believe cash burn to be a liquidity measure that provides useful information to management and investors about the amount of cash consumed by the operations of the business including milestone payments and proceeds from borrowings under the TPG financing agreement, which specifically offsets the costs of our ATHENA trial. A limitation of using this non-U.S. GAAP measure is that cash burn does not represent the total change in cash and cash equivalents for the period because it excludes all other cash provided by or used for other investing and financing activities. We account for this limitation by providing information about our investing and financing activities in the statements of cash flows in our financial statements and by presenting cash flows from investing and financing activities in our reconciliation of cash burn. In addition, it is important to note that other companies, including companies in our industry, may not use cash burn, may calculate cash burn in a different manner than we do or may use other financial measures to evaluate their performance, all of which could reduce the usefulness of cash burn as a comparative measure. Because of these limitations, cash burn should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with U.S. GAAP.

     

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    • Initial Phase 1b data from LIO-1 to be presented at the ESMO Virtual Congress 2020
    • The LIO-1 trial is part of Clovis Oncology's broad clinical collaboration with Bristol Myers Squibb

     

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today treatment of the first patient in the Phase 2 portion of the LIO-1 trial evaluating the combination of lucitanib, Clovis' investigational angiogenesis inhibitor, including vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), and Opdivo® (nivolumab), Bristol Myers Squibb's PD-1 inhibitor, for the treatment of gynecologic cancers. The LIO-1 trial is sponsored by Clovis as part of its broad clinical collaboration with Bristol Myers Squibb.

    "The Phase 2 part of the LIO-1 trial will advance…

    • Initial Phase 1b data from LIO-1 to be presented at the ESMO Virtual Congress 2020
    • The LIO-1 trial is part of Clovis Oncology's broad clinical collaboration with Bristol Myers Squibb

     

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today treatment of the first patient in the Phase 2 portion of the LIO-1 trial evaluating the combination of lucitanib, Clovis' investigational angiogenesis inhibitor, including vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), and Opdivo® (nivolumab), Bristol Myers Squibb's PD-1 inhibitor, for the treatment of gynecologic cancers. The LIO-1 trial is sponsored by Clovis as part of its broad clinical collaboration with Bristol Myers Squibb.

    "The Phase 2 part of the LIO-1 trial will advance our scientific understanding of the potential for an inhibitor of multiple tyrosine kinases, including VEGF, such as lucitanib, to be combined with a PD-1 inhibitor for the treatment of gynecologic cancers," said Dr. Erika Hamilton, Director of the Breast and Gynecologic Research Program, Sarah Cannon Research Institute at Tennessee Oncology. "It is estimated that nearly 100,000 women will be diagnosed with a gynecologic cancer in the U.S. this year alone, and it is vital that we identify new treatment options, in particular new combinations, for these women."

    The Phase 2 part of LIO-1 is an open-label study to evaluate the safety and efficacy of lucitanib and Opdivo in patients with advanced gynecological solid tumors, including a broad spectrum of ovarian and endometrial subtypes including clear cell disease and patients with cervical cancer. The primary endpoint is confirmed best overall response rate based on investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The study will be conducted in the U.S. and Europe, in collaboration with the European Network for Gynaecological Oncological Trial groups (ENGOT) for European study sites.

    The Phase 2 dosing regimen for the LIO-1 study is based on results from the recently completed Phase 1b dose-escalation portion of the LIO-1 study. Abstracts describing the initial results of the Phase 1b portion of the LIO-1 study, as well as a trials-in-progress description of the Phase 2 study design of LIO-1, have been accepted as ePosters at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 in September.

    "The initiation of the Phase 2 stage of the LIO-1 clinical trial is an important milestone for the lucitanib development program, and I am grateful to our team and our investigators for their commitment to initiating this study safely and expeditiously in this new COVID-19 era," said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. "Importantly, we look forward to sharing initial Phase 1b data from LIO-1 at the upcoming virtual ESMO Congress, as well as data for each of our commercial and development-stage products. We are committed to pursue innovative clinical studies, both monotherapy and in combination, that are supported by a strong scientific rationale and offer the potential to provide additional treatment options with meaningful clinical benefit to a broad group of cancer patients."

    More information about the LIO-1 trial (NCT04042116) is available here.

    About Lucitanib

    Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy.

    Lucitanib is an unlicensed medical product.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado; please visit www.clovisoncology.com for more information, including additional office locations in the U.S. and Europe.

    Clovis Oncology Forward-Looking Statement

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding the potential benefit of our drug candidate lucitanib in combination with nivolumab and expanding treatment options for a broader set of patient populations. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, whether future pre-clinical or clinical study results will support continued development or regulatory approval, whether our clinical development programs for our drug candidates and those of our partners can be completed on time or at all, whether future study results will be consistent with study findings to date, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to accept or approve drug applications that may be filed, as well as their decisions regarding drug labeling, reimbursement and pricing, and other matters that could affect the development, approval, availability or commercial potential of our drug candidates. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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  11. Clovis Oncology, Inc. (NASDAQ:CLVS) will announce its second quarter 2020 financial results on Thursday, August 6, 2020, after the close of the U.S. financial markets. Clovis' senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company's results in greater detail.

    The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

    Conference Call Details

    Clovis will hold a conference call to discuss second quarter 2020 results on Thursday, August 6 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company's web site at www.clovisoncology.com, and archived for future…

    Clovis Oncology, Inc. (NASDAQ:CLVS) will announce its second quarter 2020 financial results on Thursday, August 6, 2020, after the close of the U.S. financial markets. Clovis' senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company's results in greater detail.

    The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

    Conference Call Details

    Clovis will hold a conference call to discuss second quarter 2020 results on Thursday, August 6 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company's web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: U.S. participants (877) 698-7048, International participants (647) 689-5448, conference ID: 7155799.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado; please visit www.clovisoncology.com for more information, including additional office locations in the U.S. and Europe.

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  12. DUBLIN and BOULDER, Colo., June 22, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) and Clovis Oncology, Inc. (NASDAQ:CLVS) today announced positive preclinical data from a study designed to evaluate the combination potential of ALKS 4230, Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, with lucitanib, Clovis' investigational angiogenesis inhibitor. The data will be presented during a poster session at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, taking place June 22-24, 2020.

    The study evaluated the antitumor efficacy and mechanism of action of mALKS 4230, a mouse ortholog of ALKS 4230, and lucitanib as monotherapies and in combination in a preclinical syngeneic mouse model…

    DUBLIN and BOULDER, Colo., June 22, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) and Clovis Oncology, Inc. (NASDAQ:CLVS) today announced positive preclinical data from a study designed to evaluate the combination potential of ALKS 4230, Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, with lucitanib, Clovis' investigational angiogenesis inhibitor. The data will be presented during a poster session at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, taking place June 22-24, 2020.

    The study evaluated the antitumor efficacy and mechanism of action of mALKS 4230, a mouse ortholog of ALKS 4230, and lucitanib as monotherapies and in combination in a preclinical syngeneic mouse model of colon cancer. The combination of mALKS 4230 with lucitanib resulted in dose-dependent, durable complete responses (absence of any detectable tumor) and enhanced survival compared with monotherapy treatment with mALKS 4230 and lucitanib.

    "Combining treatments with complementary mechanisms may offer synergistic clinical benefit and expand treatment options for a broader set of patient populations," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "These compelling preclinical data provide a foundational rationale to further explore novel combination options, such as an angiogenesis inhibitor, for ALKS 4230, with the goal of bringing improved therapeutic outcomes to patients across multiple tumor types."

    Key findings presented in the poster include the following:

    • In the group that received the higher dose of mALKS 4230 (out of two doses tested) combined with lucitanib, 100 percent of the treated mice exhibited complete tumor regression and protection from new tumor growth upon re-challenge, an indication of the development of immunological memory.

    • The combination of mALKS 4230 with lucitanib resulted in an increase in intratumoral immune cells, including CD8+ T cells and dendritic cells, compared to monotherapy treatment, changes that are associated with anti-tumor immune responses.
    • The combination of mALKS 4230 with lucitanib elicited a distinct gene expression profile associated with anti-tumor activity, including increased immune cytolytic gene expression with decreased expression of genes with pro-angiogenic functions.



    A virtual poster titled, "The Combination of a Mouse Ortholog of ALKS 4230, a Selective Agonist of the Intermediate-Affinity IL-2 Receptor, and the Angiogenesis Inhibitor Lucitanib Enhances Antitumor Activity," along with a pre-recorded audio presentation by Dr. Jared Lopes, Principal Scientist, Alkermes will be available on the AACR website at https://www.aacr.org/meeting/aacr-annual-meeting-2020/

    About ALKS 4230 

    ALKS 4230 is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

    About Lucitanib 

    Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.

    Lucitanib is an unlicensed medical product.

    About Alkermes 

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    About Clovis Oncology 

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado; please visit www.clovisoncology.com for more information, including additional office locations in the U.S. and Europe.

    Alkermes Note Regarding Forward-Looking Statements 

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning the potential therapeutic value of ALKS 4230, as a monotherapy or in combination. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, whether preclinical and preliminary, interim or final clinical results for ALKS 4230—whether as a monotherapy or in combination—will be predictive of future data from the same studies, results of future clinical studies or real-world results; whether ALKS 4230, as a monotherapy or in combination, could be shown to be unsafe or ineffective; whether future clinical trials or future stages of ongoing clinical trials for ALKS 4230, as a monotherapy or in combination, will be initiated or completed on time or at all; changes in the cost, scope and duration of, and clinical trial operations for, development activities for ALKS 4230, including changes relating to the novel coronavirus (COVID-19); and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    Clovis Oncology Note Regarding Forward-Looking Statements

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding the potential benefit of our drug candidate lucitanib in combination with ALKS 4230 and expanding treatment options for a broader set of patient populations. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, whether future pre-clinical or clinical study results will support continued development or regulatory approval, whether our clinical development programs for our drug candidates and those of our partners can be completed on time or at all, whether future study results will be consistent with study findings to date, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to accept or approve drug applications that may be filed, as well as their decisions regarding drug labeling, reimbursement and pricing, and other matters that could affect the development, approval, availability or commercial potential of our drug candidates. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

    Alkermes Contacts:





    For Investors:

    Sandy Coombs

    +1 781 609 6377

    For Media:

    Sourojit Bhowmick, Ph.D.

    +1 781 609 6397







    Clovis Contacts:





    For Investors:

    Breanna Burkart

    +1 303 625 5023



    Anna Sussman

    +1 303 625 5022

    For Media:

    Lisa Guiterman

    +1 301 217 9353

     

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/new-preclinical-data-on-alks-4230-in-combination-with-lucitanib-to-be-presented-at-2020-american-association-for-cancer-research-aacr-virtual-annual-meeting-ii-301080515.html

    SOURCE Alkermes plc

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  13. Findings explore the pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of Rubraca and lucitanib alone and in combination with other agents in preclinical models and simulated patient populations

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that four abstracts showcasing non-clinical data from rucaparib and lucitanib development programs have been accepted for on-demand viewing and publication at the upcoming American Association for Cancer Research (AACR) Virtual Annual Meeting II, June 22 - 24, 2020.

    The accepted abstracts summarize findings from pre-clinical studies evaluating the PK, PD and anti-tumor activity of rucaparib, an oral, small molecule PARP inhibitor in orthotopic and intracranial mouse models, and…

    Findings explore the pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of Rubraca and lucitanib alone and in combination with other agents in preclinical models and simulated patient populations

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that four abstracts showcasing non-clinical data from rucaparib and lucitanib development programs have been accepted for on-demand viewing and publication at the upcoming American Association for Cancer Research (AACR) Virtual Annual Meeting II, June 22 - 24, 2020.

    The accepted abstracts summarize findings from pre-clinical studies evaluating the PK, PD and anti-tumor activity of rucaparib, an oral, small molecule PARP inhibitor in orthotopic and intracranial mouse models, and its synergy with CHK1 inhibition in tumor cell lines. Additional abstracts include findings from a study of the pharmacokinetics of lucitanib, an oral, potent inhibitor of tyrosine kinase activity, in a simulated patient population to inform dosing-regimen selection, and from a pre-clinical study evaluating the anti-tumor efficacy and mechanism of action of lucitanib in combination with a mouse ortholog of ALKS 4230, a selective agonist of the intermediate affinity IL-2 receptor, in a mouse colon cancer model. Lucitanib and ALKS 4230 are both development-stage compounds.

    "Data from our ongoing non-clinical studies underscore our commitment to pursuing innovative research that advances novel therapies for cancer patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "In particular, we are pleased to present new, non-clinical data exploring the PK/PD of our PARP inhibitor Rubraca, evaluating the synergies of PARP and CHK1 inhibition in combination, as well as important data for lucitanib to understand optimal dosing and use in combination with other anticancer agents to treat solid tumors."

    The following Clovis-sponsored, collaborator-sponsored and investigator-sponsored abstracts will be available as AACR 2020 Virtual Poster Session presentations. E-posters, and when available, accompanying audio descriptions, will be available for on-demand viewing beginning 9:00 a.m. EDT Monday, June 22, and will remain available for viewing by registered attendees for at least three months after the virtual meeting.

    Abstract Number: 3026 / 14 - Evaluation of brain pharmacokinetics (PK) and tumor growth inhibition of PARP inhibitors in mouse xenograft models using semi-mechanistic PK/pharmacodynamic (PD) modeling

    • Presenting Author: Michelle Liao
    • Session: Pharmacokinetics / Pharmacodynamics

    Abstract Number: 3027 / 15 - Application of machine learning and grid search approaches to minimize lucitanib pharmacokinetic variability following different dosing regimens

    • Presenting Author: Michelle Liao
    • Session: Pharmacokinetics / Pharmacodynamics

    Abstract Number: 2202 / 7 - The combination of a mouse ortholog of ALKS 4230, a selective agonist of the intermediate affinity IL-2 receptor, and the angiogenesis inhibitor lucitanib enhances antitumor activity

    • Presenting Author: Jared E. Lopes
    • Session: Combination Immunotherapies 2

    In addition, the three previous posters will be available on the Clovis Oncology website once they become available on the AACR virtual meeting website.

    Abstract Number: 1375 / 11 - Investigating synergy between CHK1 and PARP inhibitors in BRCA2 mutant and restored cells

    • Presenting Author: Hannah L. Smith
    • Session: Mechanisms of DNA Damaging Therapeutics

    About Rubraca (rucaparib)

    Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

    In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy. Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

    Rubraca is an unlicensed medical product outside of the U.S. and Europe.

    About Lucitanib

    Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.

    Lucitanib is an unlicensed medical product.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations for submission of regulatory filings, the timing and pace of commencement of and enrollment in our clinical trials, including those being planned or conducted in collaboration with partners, the potential results of such clinical trials, our expectations regarding the suitability of Rubraca for, and our plans to develop Rubraca in, additional indications and tumor types. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates and those of our partners, whether future study results will be consistent with study findings to date, the timing of availability of data from our clinical trials and the initiation, enrollment, timing and results of our planned clinical trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, the risk that additional pre-clinical or clinical studies may not support further development in certain additional indications or tumor types, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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    • Topline data for Rubraca monotherapy arm vs placebo expected 2H 2021; intended to support a supplemental New Drug Application filing (sNDA)
    • Topline data from Rubraca and Opdivo in combination vs Rubraca monotherapy expected one year or more later

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today the completion of target patient enrollment in the Clovis-sponsored Phase 3 ATHENA trial evaluating the combination of Clovis' Rubraca®(rucaparib), a poly (ADP ribose) polymerase inhibitor (PARP), and Bristol-Myers Squibb's PD-1 inhibitor, OPDIVO® (nivolumab), as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer. ATHENA is the first front-line switch maintenance study designed to show PARP monotherapy and PARP/PD-1 combination…

    • Topline data for Rubraca monotherapy arm vs placebo expected 2H 2021; intended to support a supplemental New Drug Application filing (sNDA)
    • Topline data from Rubraca and Opdivo in combination vs Rubraca monotherapy expected one year or more later

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today the completion of target patient enrollment in the Clovis-sponsored Phase 3 ATHENA trial evaluating the combination of Clovis' Rubraca® (rucaparib), a poly (ADP ribose) polymerase inhibitor (PARP), and Bristol-Myers Squibb's PD-1 inhibitor, OPDIVO® (nivolumab), as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer. ATHENA is the first front-line switch maintenance study designed to show PARP monotherapy and PARP/PD-1 combination therapy in one study design.

    "The completion of target patient enrollment in the Phase 3 ATHENA trial is an important milestone for Clovis and a critical step toward developing additional therapeutic options for women with advanced ovarian cancer," said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. "This was a tremendous effort by trial investigators, our collaborators and our dedicated Clovis team to complete target enrollment in this 1,000-patient study in under two years. Most important, we are grateful to all of the patients who participated in this study."

    ATHENA is a Phase 3, randomized, multinational, double-blind, placebo-controlled, four-arm trial evaluating Rubraca and Opdivo as maintenance treatment following response to front-line treatment in newly-diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. The primary endpoint is investigator assessed progression-free survival (PFS); secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety.

    Target enrollment for the ATHENA trial was 1,000 ovarian cancer patients. Patients were enrolled at clinical trial centers in 24 countries including North America, Europe and Asia.

    Topline data for the Rubraca monotherapy versus placebo arm in all study populations is expected in the second half of 2021 and, if supportive, would serve as the basis of an sNDA for the maintenance treatment of front-line, newly-diagnosed, advanced ovarian cancer patients. Topline data for the combination of Rubraca and Opdivo versus Rubraca monotherapy in all study populations are expected a year or more later and, if supportive, would serve as the basis of an sNDA for the combination therapy in front-line, newly-diagnosed ovarian cancer. In each of these, the primary efficacy analysis will evaluate two prospectively defined molecular sub-groups in a step-down manner: first, HRD-positive patients, including BRCA-mutant patients; and the intent-to-treat population, or all patients treated in ATHENA.

    About Rubraca (rucaparib)

    Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, and lung cancers. Clovis holds worldwide rights for Rubraca.

    In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy. Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

    Rubraca is an unlicensed medical product outside of the U.S. and Europe.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements contained in this press release include, among others, our expectations regarding the timing and pace of conduct of our clinical trials, including those being planned or conducted in collaboration with partners, the potential results of such clinical trials, our plans for submission of regulatory filings, and our plans to present data on ongoing clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the impacts of the COVID-19 pandemic and disruption on our ability to continue our development activities, impacts on the conduct of our clinical trials, including with respect to availability of investigators and clinical trial sites or monitoring of data, whether our clinical development programs for our drug candidates and those of our partners can be completed on time or at all, the timing of availability of data from our clinical trials and the results, actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to accept or approve drug applications that may be filed, their interpretations of our data and agreement with our regulatory approval strategies or components of our filings, including our clinical trial designs, conduct and methodologies, as well as their decisions regarding drug labeling, reimbursement and pricing, and other matters that could affect the development, approval, availability or commercial potential of our drug candidates or companion diagnostics. In particular, there are no guarantees that future study results and patient experience will be consistent with the study findings to date, that Rubraca will receive regulatory approval for any future indications, or that it will prove to be commercially successful. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K. All forward-looking statements are based on information currently available to the company, and Clovis Oncology does not undertake to update or revise any forward-looking statements

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  14. Rubraca recommended as a treatment option for BRCA-mutant mCRPC in the second line setting and as a subsequent therapy; if the patient is not fit for chemotherapy, rucaparib can be considered prior to taxane

    Clovis Oncology, Inc. (NASDAQ:CLVS), announced today that the National Comprehensive Cancer Network® (NCCN) updated its Clinical Practice Guidelines in Oncology for Prostate Cancer to include new recommendations for Rubraca® (rucaparib) tablets.i In addition to its ovarian cancer recommendations, Rubraca is now recommended in the NCCN Guidelines® for the treatment of BRCA-mutant patients with mCRPC under second-line treatment and subsequent therapy as a Category 2A recommendation inclusive of the following:

    Rucaparib is a treatment

    Rubraca recommended as a treatment option for BRCA-mutant mCRPC in the second line setting and as a subsequent therapy; if the patient is not fit for chemotherapy, rucaparib can be considered prior to taxane

    Clovis Oncology, Inc. (NASDAQ:CLVS), announced today that the National Comprehensive Cancer Network® (NCCN) updated its Clinical Practice Guidelines in Oncology for Prostate Cancer to include new recommendations for Rubraca® (rucaparib) tablets.i In addition to its ovarian cancer recommendations, Rubraca is now recommended in the NCCN Guidelines® for the treatment of BRCA-mutant patients with mCRPC under second-line treatment and subsequent therapy as a Category 2A recommendation inclusive of the following:

    Rucaparib is a treatment option for patients with mCRPC and a pathogenic BRCA1 or BRCA2 mutation (germline and/or somatic) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. If the patient is not fit for chemotherapy, rucaparib can be considered even if taxane-based therapy has not been given.

    "We are pleased that the NCCN has acknowledged the importance of novel targeted therapies for the treatment of advanced prostate cancer, and the need for new treatment options for patients with BRCA mutations, including Rubraca, the first PARP inhibitor approved for these patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "In particular, in the current COVID-19 environment, many patients would prefer to avoid chemotherapy, which requires frequent clinical visits, in favor of an oral agent that can be delivered directly to and taken at home."

    NCCN Guidelines are the recognized standard for clinical direction and policy in cancer care and are the most thorough and frequently updated clinical practice guidelines available in any area of medicine.ii The NCCN prostate cancer panel's decision to include Rubraca as a Category 2A preferred option for the treatment of patients with a BRCA mutation for second-line treatment and subsequent therapy was based on the results of the Phase 2 TRITON2 study.

    About Prostate Cancer

    The American Cancer Society estimates that nearly 192,000 men in the United States will be diagnosed with prostate cancer in 2020iii, and the GLOBOCAN Cancer Fact Sheets estimated that approximately 450,000 men in Europe were diagnosed with prostate cancer in 2018.iv Castration-resistant prostate cancer has a high likelihood of developing metastases. Metastatic castration-resistant prostate cancer, or mCRPC, is an incurable disease, usually associated with poor prognosis. Approximately 43,000 men in the U.S. are expected to be diagnosed with mCRPC in 2020.v According to the American Cancer Society, the five-year survival rate for mCRPC is approximately 30 percent.vi Approximately 12 percent of patients with mCRPC harbor a deleterious germline and/or somatic mutation in the genes BRCA1 and BRCA2. These molecular markers may be used to select patients for treatment with a PARP inhibitor.vii

    Rubraca U.S. FDA Approved Indication

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

    This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Click here for full Prescribing Information for Rubraca.

    You may also report side effects to Clovis Oncology, Inc. at 1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US toll-free).

    About Accessing Rubraca

    Rubraca is available in the United States through specialty pharmacies and distributors. Clovis is committed to ensuring Rubraca access for patients and offers eligible patients financial and reimbursement support through Rubraca Connections. More information about Rubraca Connections is available at RubracaConnections.com or by calling 1-844-779-7707 between 8 a.m. and 8 p.m. Eastern Time, Monday through Friday.

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    This press release contains forward-looking statements (as defined under the Private Securities Litigation Reform Act of 1995) about the potential of Rubraca® (rucaparib) for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy, and reflects Clovis Oncology's current beliefs. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. In particular, there are no guarantees that future study results and patient experience will be consistent with the study findings to date, that Rubraca will receive regulatory approval for any future indications, or that it will prove to be commercially successful. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K. All forward-looking statements are based on information currently available to the company, and Clovis Oncology does not undertake to update or revise any forward-looking statements

    i NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2020. Accessed May 21, 2020.

    ii NCCN website. About NCCN Guidelines. https://www.nccn.org/professionals/default.aspx. Accessed May 27, 2020.

    iii American Cancer Society. Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed January 30, 2020.

    iv GLOBOCAN Cancer Fact Sheets: prostate cancer. Prostate Cancer Estimated Incidence, Mortality and Prevalence Worldwide in 2018. https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf. Accessed February 4, 2020.

    v Cameron A. Wade and Natasha Kyprianou. Profiling Prostate Cancer Therapeutic Resistance. International Journal of Molecular Sciences. 2018, 19, 204. https://www.mdpi.com/1422-0067/19/3/904/pdf.

    vi American Cancer Society. Survival rates for prostate cancer. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html. Accessed February 4, 2020.

    vii Abida W, Armenia J, Gopalan A, et al. Prospective Genomic Profiling of Prostate Cancer Across Disease States Reveals Germline and Somatic Alterations That May Affect Clinical Decision Making. JCO Precis Oncol 2017: 1-16.

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  15. Scientific data describe clinical experience and potential of Rubraca in multiple solid tumor types

    Clovis Oncology, Inc. (NASDAQ:CLVS), announced today that six abstracts featuring data from clinical and real-world evidence studies evaluating Rubraca® (rucaparib) in multiple tumor types have been accepted for presentation or publication at the American Society of Clinical Oncology 2020 Virtual Scientific Program taking place May 29 – 31.

    The accepted abstracts summarize findings from clinical trials in which Rubraca was evaluated as a single-agent therapy in ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC) and malignant mesothelioma, and in combination with irinotecan in multiple advanced solid tumors, as well as…

    Scientific data describe clinical experience and potential of Rubraca in multiple solid tumor types

    Clovis Oncology, Inc. (NASDAQ:CLVS), announced today that six abstracts featuring data from clinical and real-world evidence studies evaluating Rubraca® (rucaparib) in multiple tumor types have been accepted for presentation or publication at the American Society of Clinical Oncology 2020 Virtual Scientific Program taking place May 29 – 31.

    The accepted abstracts summarize findings from clinical trials in which Rubraca was evaluated as a single-agent therapy in ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC) and malignant mesothelioma, and in combination with irinotecan in multiple advanced solid tumors, as well as findings from real-world evidence studies of the epidemiology and current treatment landscape of mCRPC.

    "We continue to be encouraged by data demonstrating the potential of Rubraca beyond ovarian cancer and look forward to sharing new findings from some of the studies exploring its broader utility and value," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "This year's virtual ASCO scientific program provides a timely opportunity to share key clinical updates with the research and medical community, continuing the important dialogue around the adoption and utilization of PARP inhibitors more broadly, and Rubraca in particular."

    The following Clovis-sponsored Rubraca abstract has been selected for poster discussion and is available now in the ASCO meeting library.

    Abstract Number: 6015, Poster Number: 186 - Characterization of Patients (pts) with Long-term Responses to Rucaparib in Recurrent Ovarian Cancer (OC)

    • Presenting Author: Elizabeth M. Swisher, MD
    • Session: Gynecologic Cancer

    The poster and a discussant presentation will be available on demand by accessing the ASCO meeting library beginning Friday, May 29 at 8:00am EDT. In addition, the poster will be available at https://www.clovisoncology.com/pipeline/scientific-presentations/ once it becomes available in the ASCO meeting library.

    The two following Clovis-sponsored abstracts are available now in the ASCO meeting library:

    Abstract Number: e19319 (online abstract publication) - Real-world Evidence of Treatment Patterns and Pharmacy Costs Among Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) in a Managed Care Population in the United States

    • Authors: Kelvin A. Moses, MD, PhD, et al.

    Abstract Number: e13592 (online abstract publication) - Epidemiology and Mortality of Metastatic Castration-Resistant Prostate Cancer (mCRPC) in a Managed Care Population in the United States

    • Authors: Katrine Wallace, PhD, et al.

    Additionally, the following three investigator-sponsored abstracts describing studies of Rubraca have also been selected for presentation as part of the 2020 ASCO scientific program and are available now in the ASCO meeting library.

    Abstract Number: 3513, Poster Number: 243 - Phase 1 Study of Rucaparib and Irinotecan in Advanced Solid Tumors with Homologous Recombination Deficiency (HRD) Mutations

    • Presenting Author: Mallika S. Dhawan, MD
    • Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

    The poster and a discussant presentation will be available on demand by accessing the ASCO meeting library beginning Friday, May 29 at 8:00am EDT.

    Abstract Number: 9057, Poster Number: 250 - MiST1: A Phase IIa Trial of Rucaparib in Patients Harboring BAP1/BRCA1 Deficient Relapsed Malignant Mesothelioma

    • Presenting Author: Dean A. Fennell, FRCP, PhD
    • Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

    The poster will be available on demand by accessing the ASCO meeting library beginning Friday, May 29 at 8:00am EDT.

    Abstract Number: TPS6102, Poster Number: 273 - NOGGO Ov-42/MAMOC: Rucaparib Maintenance After Bevacizumab Maintenance Following Carboplatin-Based First-Line Chemotherapy in Ovarian Cancer Patients

    • Presenting Author: Elena I. Braicu, MD, PhD
    • Session: Gynecologic Cancer

    The poster will be available on demand by accessing the ASCO meeting library beginning Friday, May 29 at 8:00am EDT.

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

    Rubraca U.S. FDA Approved Indications

    Ovarian Cancer

    Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

    Rubraca is indicated for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

    Prostate Cancer

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. For males on Rubraca treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

    Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

    Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

    Please click here for full Prescribing Information for Rubraca.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations for submission of regulatory filings, the timing and pace of commencement of and enrollment in our clinical trials, including those being planned or conducted in collaboration with partners, the potential results of such clinical trials, our expectations regarding the suitability of Rubraca for, and our plans to develop Rubraca in, additional indications and tumor types. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates and those of our partners, whether future study results will be consistent with study findings to date, the timing of availability of data from our clinical trials and the initiation, enrollment, timing and results of our planned clinical trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, the risk that additional pre-clinical or clinical studies may not support further development in certain additional indications or tumor types, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

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  16. Clovis Oncology, Inc. (NASDAQ:CLVS) announced today the pricing of 11,090,000 shares of its common stock in an underwritten public offering at a price to the public of $8.05 per share, before underwriting discounts and commissions. Clovis Oncology also granted to the underwriters a 30-day option to purchase up to an additional 1,663,500 shares of its common stock on the same terms and conditions.

    The offering is expected to close on May 21, 2020, subject to customary closing conditions. J. P. Morgan Securities LLC and BofA Securities are acting as joint book-running managers for this offering.

    Clovis Oncology intends to use the net proceeds of this offering for general corporate purposes, including repayment, repurchase or refinance of…

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today the pricing of 11,090,000 shares of its common stock in an underwritten public offering at a price to the public of $8.05 per share, before underwriting discounts and commissions. Clovis Oncology also granted to the underwriters a 30-day option to purchase up to an additional 1,663,500 shares of its common stock on the same terms and conditions.

    The offering is expected to close on May 21, 2020, subject to customary closing conditions. J. P. Morgan Securities LLC and BofA Securities are acting as joint book-running managers for this offering.

    Clovis Oncology intends to use the net proceeds of this offering for general corporate purposes, including repayment, repurchase or refinance of its debt obligations, sales and marketing expenses associated with Rubraca® (rucaparib), funding of its development programs, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

    The common stock is being offered pursuant to an effective shelf registration statement that Clovis Oncology has filed with the Securities and Exchange Commission ("SEC"). Before you invest, you should read the prospectus in that registration statement and other documents Clovis Oncology has filed with the SEC for more complete information about Clovis Oncology and this offering. The offering is being made only by means of a prospectus supplement and the related prospectus. Copies of the prospectus supplement and related prospectus may be obtained from J. P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email to , or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department, or by calling 1-800-294-1322 or by email to . You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC's website at www.sec.gov.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado with additional office locations in the U.S. and Europe.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties that could cause Clovis Oncology's actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the conditions affecting the capital markets, general economic, industry, or political conditions, including the impact of the COVID-19 pandemic, and the satisfaction of customary closing conditions related to the proposed public offering. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see the prospectus supplement and related prospectus for this offering as well as Clovis Oncology's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its other reports filed with the Securities and Exchange Commission.

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  17. Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that it has commenced an underwritten public offering of common stock.

    Clovis Oncology intends to offer, subject to market and other conditions, $85 million of shares of its common stock in an underwritten registered public offering. In connection with this offering, Clovis Oncology intends to grant to the underwriters a 30-day option to purchase up to an additional $12.75 million of shares of its common stock on the same terms and conditions. All shares of the common stock to be sold in the offering will be offered by Clovis Oncology.

    Clovis Oncology intends to use the net proceeds of this offering for general corporate purposes, including repayment, repurchase or refinance of its debt…

    Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that it has commenced an underwritten public offering of common stock.

    Clovis Oncology intends to offer, subject to market and other conditions, $85 million of shares of its common stock in an underwritten registered public offering. In connection with this offering, Clovis Oncology intends to grant to the underwriters a 30-day option to purchase up to an additional $12.75 million of shares of its common stock on the same terms and conditions. All shares of the common stock to be sold in the offering will be offered by Clovis Oncology.

    Clovis Oncology intends to use the net proceeds of this offering for general corporate purposes, including repayment, repurchase or refinance of its debt obligations, sales and marketing expenses associated with Rubraca® (rucaparib), funding of its development programs, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

    J. P. Morgan Securities LLC and BofA Securities are acting as joint book-running managers for the offering.

    The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The common stock is being offered pursuant to an effective shelf registration statement that Clovis Oncology has filed with the Securities and Exchange Commission ("SEC"). Before you invest, you should read the prospectus in that registration statement and other documents Clovis Oncology has filed with the SEC for more complete information about Clovis Oncology and this offering. The offering is being made only by means of a prospectus supplement and the related prospectus. Copies of the prospectus supplement and related prospectus may be obtained from J. P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email to , or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department, or by calling 1-800-294-1322 or by email to . You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC's website at www.sec.gov.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado with additional office locations in the U.S. and Europe.

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties that could cause Clovis Oncology's actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and size of the offering, the conditions affecting the capital markets, general economic, industry, or political conditions, including the impact of the COVID-19 pandemic, and the satisfaction of customary closing conditions related to the proposed public offering. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see the prospectus supplement and related prospectus for this offering as well as Clovis Oncology's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its other reports filed with the Securities and Exchange Commission.

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  18. Rubraca is the first PARP inhibitor approved in a prostate cancer setting

    Accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the TRITON2 clinical triali

    44% ORR (95% CI 31, 57) and median DOR not evaluable (95% CI 6.4, NE, range in months at data cutoff 1.7-24.0+) by blinded independent radiologic review (IRR)i

    Most common Grade 3-4 adverse reaction was anemia; most common Grade 3-4 lab abnormality was decrease in hemoglobini

    Clovis Oncology, Inc. (NASDAQ:CLVS), announced today that the U.S. Food and Drug Administration (FDA) approved Rubraca® (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant…

    Rubraca is the first PARP inhibitor approved in a prostate cancer setting

    Accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the TRITON2 clinical triali

    44% ORR (95% CI 31, 57) and median DOR not evaluable (95% CI 6.4, NE, range in months at data cutoff 1.7-24.0+) by blinded independent radiologic review (IRR)i

    Most common Grade 3-4 adverse reaction was anemia; most common Grade 3-4 lab abnormality was decrease in hemoglobini

    Clovis Oncology, Inc. (NASDAQ:CLVS), announced today that the U.S. Food and Drug Administration (FDA) approved Rubraca® (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this indication under accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the multi-center, single arm TRITON2 clinical trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC. Warning and precautions include myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and embryo-fetal toxicity. Please see additional warnings and precautions and select safety information below.i

    "Standard treatment options for men with mCRPC have been limited to androgen receptor-targeting therapies, taxane chemotherapy, Radium-223 and sipuleucel-T," said Wassim Abida, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center, and Principal Investigator for the TRITON2 study. "Rubraca is the first in a class of drugs to become newly available to patients with mCRPC who harbor a deleterious BRCA mutation. Given the level and duration of responses observed with Rubraca in men with mCRPC and these mutations, it represents an important and timely new treatment option for this patient population."

    The FDA approval for this third indication for Rubraca is based on efficacy data from patients with mCRPC and a deleterious BRCA mutation (germline and/or somatic) enrolled in the multi-center, single arm TRITON2 (NCT02952534) clinical trial. The major efficacy outcomes are confirmed ORR and DOR by modified RECIST version 1.1/PCWG3 criteria assessed by blinded independent radiologic review (IRR). Confirmed prostate-specific antigen (PSA) response rate is an additional prespecified endpoint.i,ii

    Evaluable patient populations in the supplemental New Drug Application dataset included the following: 62 RECIST-evaluable patients with a BRCA (germline and/or somatic) mutation and measurable disease (IRR); 115 patients with a BRCA (germline and/or somatic) mutation and measurable or non-measurable disease; and 209 patients with HRD-positive mCRPC enrolled in TRITON2. Patients should be selected for treatment of mCRPC with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic).i

    Efficacy outcomes and safety results are summarized belowi:

    • 44% ORR (N=62; 95% CI 31, 57) by blinded-IRR assessment.
      • Objective response rates were similar for patients with a germline BRCA versus somatic BRCA mutation.
    • Median DOR by blinded-IRR assessment was not evaluable (NE) at data cut-off.

     

    Rubraca

    (N=62)

    Confirmed Objective Response Rate (95% CI)a

    44% (31, 57)

    Median DOR in months (95% CI)b

    NE (6.4, NE)

    NE = not evaluable

    aDefined per modified RECIST v1.1 criteria and with no confirmed bone progression per PCWG3.

    bThe range for the DOR was 1.7-24+ months. Fifteen of the 27 (56%) patients with a confirmed objective response had a DOR of ≥ 6 months.

    Additionally, a 55% confirmed prostate specific antigen (PSA) response rate (95% CI 45, 64) was observed in an analysis of 115 patients with a deleterious BRCA mutation (germline and/or somatic) and measurable or non-measurable disease.ii

    The safety evaluation of Rubraca 600 mg twice daily as monotherapy treatment is based on an analysis of 209 patients with HRD-positive mCRPC from the multi-center, single arm TRITON2 clinical study, including 115 with BRCA-mutated mCRPC. The most common adverse reactions (greater than or equal to 20% of patients; CTCAE Grade 1-4) occurring in the BRCA mutant population (n=115) were asthenia/fatigue, nausea, anemia, ALT/AST increased, decreased appetite, constipation, rash, thrombocytopenia, vomiting, and diarrhea. The most common laboratory abnormalities (greater than or equal to 35% of patients; CTCAE Grade 1-4) were increase in ALT, decrease in leukocytes, decrease in phosphate, decrease in absolute neutrophil count, decrease in hemoglobin, increase in alkaline phosphatase, increase in creatinine, increase in triglycerides, decrease in lymphocytes, decrease in platelets, and decrease in sodium.i

    "The data from the TRITON2 clinical trial supporting the FDA approval of Rubraca in mCRPC have been highly consistent over time, and we are pleased that the FDA has granted an accelerated approval for Rubraca in this third indication," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are proud to offer Rubraca as a new treatment option to physicians and eligible prostate cancer patients with a deleterious BRCA mutation beginning today."

    "The FDA approval of Rubraca is a significant milestone for patients with metastatic castration-resistant prostate cancer and a deleterious BRCA mutation," said Howard Soule, Ph.D., Executive Vice President and Chief Science Officer of the Prostate Cancer Foundation. "Although new treatments for prostate cancer have been approved in recent years, most men living with advanced stages of this disease continue to face a difficult journey with few treatment options."

    About Prostate Cancer

    The American Cancer Society estimates that nearly 192,000 men in the United States will be diagnosed with prostate cancer in 2020iii, and the GLOBOCAN Cancer Fact Sheets estimated that approximately 450,000 men in Europe were diagnosed with prostate cancer in 2018.iv Castration-resistant prostate cancer has a high likelihood of developing metastases. Metastatic castration-resistant prostate cancer, or mCRPC, is an incurable disease, usually associated with poor prognosis. Approximately 43,000 men in the U.S. are expected to be diagnosed with mCRPC in 2020.v According to the American Cancer Society, the five-year survival rate for mCRPC is approximately 30 percent.vi Approximately 12 percent of patients with mCRPC harbor a deleterious germline and/or somatic mutation in the genes BRCA1 and BRCA2. These molecular markers may be used to select patients for treatment with a PARP inhibitor.vii

    Rubraca U.S. FDA Approved Indication

    Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

    This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Select Important Safety Information

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

    Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

    Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

    Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

    Click here for full Prescribing Information for Rubraca.

    You may also report side effects to Clovis Oncology, Inc. at 1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US toll-free).

    About Accessing Rubraca

    Rubraca is available in the United States through specialty pharmacies and distributors. Clovis is committed to ensuring Rubraca access for patients and offers eligible patients financial and reimbursement support through Rubraca Connections. More information about Rubraca Connections is available at RubracaConnections.com or by calling 1-844-779-7707 between 8 a.m. and 8 p.m. Eastern Time, Monday through Friday.

    About Rubraca (rucaparib)

    Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

    About Clovis Oncology

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.

    This press release contains forward-looking statements (as defined under the Private Securities Litigation Reform Act of 1995) about the potential of Rubraca® (rucaparib) for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy, and reflects Clovis Oncology's current beliefs. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. In particular, there are no guarantees that future study results and patient experience will be consistent with the study findings to date, that Rubraca will receive regulatory approval for any future indications, or that it will prove to be commercially successful. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K. All forward-looking statements are based on information currently available to the company, and Clovis Oncology does not undertake to update or revise any forward-looking statements

    __________________

    i

    Rubraca [package insert]. Boulder, CO; Clovis Oncology. 2020

    ii

    Data on file. Clovis Oncology; Boulder, CO

    iii

    American Cancer Society. Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed January 30, 2020.