CLVS Clovis Oncology Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Lucitanib with Rubraca (SEASTAR)
Ovarian cancer
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Phase 1/2
Phase 1/2
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Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
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Opdivo and Rubraca ATHENA
Ovarian Cancer - First-line maintenance treatment
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Lucitanib with Opdivo
Solid tumors
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Phase 1/2
Phase 1/2
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Phase 1b/2 trial ongoing.
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Rubraca (rucaparib)
Castrate-resistant prostate cancer (mCRPC)
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Approved
Approved
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FDA Approval announced May 15, 2020.
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Rucaparib - LODESTAR
Solid tumors
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Phase 2
Phase 2
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Phase 2 trial initiated 4Q 2019.
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Rucaparib - ATLAS
Urothelial carcinoma
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Phase 2
Phase 2
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Phase 2 trial to be discontinued due to lack of efficacy - April 12, 2019.
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Rucaparib ARIEL4
Relapsed ovarian cancer patients with BRCA mutations
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Phase 3
Phase 3
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Phase 3 confirmatory trial is enrolling.
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Rucaparib
Platinum-sensitive pancreatic cancer
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Phase 2
Phase 2
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Phase 2 data presented at AACR April 2019. PFS 9.1 months.
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Opdivo and Rubraca
Triple-negative breast cancers
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Phase 3
Phase 3
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Phase 3 trial planned.
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Rucaparib ARIEL3
Ovarian cancer patients with a BRCA-like mutation
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Approved
Approved
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Approval announced April 6, 2018.
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Rucaparib ARIEL2
Cancer - ovarian second line
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Approved
Approved
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Approved December 19, 2016. Original PDUFA date under priority review was February 23, 2017.
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Rociletinib
Mutant EGFR T790M-positive lung cancer
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CRL
CRL
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PDUFA date was June 28, 2016. Company expect CRL. Phase 3 TIGER-3 also terminated.
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Latest News
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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
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.htmlSOURCE Alkermes plc
- 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.
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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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200617005130/en/
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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 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20200610005746/en/
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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.View source version on businesswire.com: https://www.businesswire.com/news/home/20200528005462/en/
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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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200521005616/en/