PBYI Puma Biotechnology Inc

2.4
-0.12  -5%
Previous Close 2.52
Open 2.46
52 Week Low 2.445
52 Week High 14.14
Market Cap $98,125,548
Shares 40,885,645
Float 34,297,679
Enterprise Value $127,749,548
Volume 1,057,346
Av. Daily Volume 770,642
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Upcoming Catalysts

Drug Stage Catalyst Date
KADCYLA (trastuzumab emtansine) plus NERLYNX (Neratinib) - (TBCRC-022)
HER2 positive breast cancer with brain metastases
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
NERLYNX (neratinib)
Glioblastoma (GBM)
Phase 2
Phase 2
Phase 2 results reported that in the intent-to-treat population, there was no significant improvement of PFS and OS. Median PFS with neratinib was 6.0 months versus 4.7 months and median OS was 13.8 months 14.7 months, noted November 20, 2021.
NERLYNX (Neratinib) monotherapy with high dose loperamide prophylaxis - (CONTROL)
Extended adjuvant treatment of early stage HER2-positive breast cancer
Phase 2
Phase 2
Phase 2 dose escalation final findings reported that Neratinib DE + loperamide PRN during the first 2 weeks of treatment was associated with the lowest rates of grade 3 diarrhea (13.3%) and diarrhea-related discontinuations (3.3%) compared with all other anti-diarrheal strategies investigated in the trial, noted December 13, 2021.
NERLYNX (Neratinib) - SUMMIT
Metastatic triple negative breast cancer with a HER2 mutation
Phase 2
Phase 2
Phase 2 separate TNBC cohort data update results demonstrated that for the patients dosed, 12 patients (46.2%) experienced a confirmed OR, all of which were PR, and 15 patients (57.7%) experienced clinical benefit (clinical benefit for at least 24 weeks). The median duration of response was 14.4 months and the median PFS was 8.2 months, noted December 10, 2021.
NERLYNX (Neratinib) - SUMMIT
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Phase 2
Phase 2
Phase 2 data released January 15, 2021 noted objective response rate of 16% (4/25 partial responses) in patients with biliary cancer.
NERLYNX (neratinib) and Xeloda (capecitabine)
HER2-negative breast cancer
Phase 2
Phase 2
Phase 2 enrollment to begin by mid-2022.
NERLYNX (neratinib) - NALA
Third-line HER2-positive metastatic breast cancer
Approved
Approved
FDA Approval announced February 26, 2020.
NERLYNX (Neratinib)
Extended adjuvant HER2-positive early stage breast cancer
Approved
Approved
Approval announced July 17, 2017. Advisory Committee Meeting May 24, 2017 voted 12-4 in favor of recommending approval.

Latest News

  1. Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that on January 18, 2022 the Compensation Committee of Puma's Board of Directors approved the grant of an inducement restricted stock unit award covering 11,250 shares of Puma common stock to one new non-executive employee.

    The award was granted under Puma's 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit award vests over a three-year period, with one-third of the shares underlying the award vesting on the first anniversary of the award's vesting commencement date, January 1, 2022, and one-sixth of the shares underlying the award…

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that on January 18, 2022 the Compensation Committee of Puma's Board of Directors approved the grant of an inducement restricted stock unit award covering 11,250 shares of Puma common stock to one new non-executive employee.

    The award was granted under Puma's 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit award vests over a three-year period, with one-third of the shares underlying the award vesting on the first anniversary of the award's vesting commencement date, January 1, 2022, and one-sixth of the shares underlying the award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The award was granted as an inducement material to the new employee entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4).

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

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  2. Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of breast cancer have been updated for 2022 and include two important changes involving neratinib (NERLYNX®).

    The first update added NERLYNX to the body of the guidelines for the treatment of adjuvant HER2-positive Breast Cancer (BINV-L) under the heading Useful in Certain Circumstances, with a recommendation for considering extended adjuvant neratinib for patients with HR-positive, HER2-positive disease with a perceived high risk of recurrence.

    The second update involved the inclusion of dose escalation as an approach to improve the…

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of breast cancer have been updated for 2022 and include two important changes involving neratinib (NERLYNX®).

    The first update added NERLYNX to the body of the guidelines for the treatment of adjuvant HER2-positive Breast Cancer (BINV-L) under the heading Useful in Certain Circumstances, with a recommendation for considering extended adjuvant neratinib for patients with HR-positive, HER2-positive disease with a perceived high risk of recurrence.

    The second update involved the inclusion of dose escalation as an approach to improve the tolerability of neratinib in the treatment of adjuvant HER2-positive Breast Cancer (BINV-L). This update aligns with the labeling supplement to the U.S. Prescribing Information approved by the U.S. Food and Drug Administration in June 2021, which incorporated the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL study.

    Joyce O'Shaughnessy, M.D., Baylor University Medical Center, Texas Oncology, US Oncology, Dallas Texas, said, "Oncologists should be aware of an important recent update to the NCCN guidelines that now include adjuvant neratinib to be used in certain circumstances, i.e., high-risk HR+, HER2+ early-stage breast cancer patients. These high-risk patients need access to every available treatment option proven to decrease their risk of recurrence, and the new NCCN guidelines update supports neratinib in this context."

    Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "The NCCN guidelines are utilized by many institutions, practices and clinicians who treat breast cancer patients. These updates help to increase the awareness of neratinib within the guidelines and should further support neratinib as an appropriate option to reduce the risk of recurrence for patients battling HER2-positive breast cancer."

    About HER2-Positive Breast Cancer

    Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

    About the National Comprehensive Cancer Network

    The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation®. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information.

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early-stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

    Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.

    Important Safety Information Regarding NERLYNX® (neratinib) U.S. Indication

    NERLYNX® (neratinib) tablets, for oral use

    INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

    • As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
    • In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.

    CONTRAINDICATIONS: None

    WARNINGS AND PRECAUTIONS:

    • Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite dose escalation or loperamide, treat with loperamide, additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
    • Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
    • Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

    ADVERSE REACTIONS:

    The most common adverse reactions (reported in ≥ 5% of patients) were as follows:

    • NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.
    • NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

    To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS:

    • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids.
    • Strong CYP3A4 inhibitors: Avoid concomitant use.
    • P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.
    • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
    • Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX.

    USE IN SPECIFIC POPULATIONS:

    • Lactation: Advise women not to breastfeed.

    Please see Full Prescribing Information for additional safety information.

    To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

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  3. Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, provided an update to the corporate presentation that its Chief Executive Officer and President, Alan H. Auerbach, presented at the virtual H.C. Wainwright BioConnect Conference, which began at 7:00 a.m. EST on Monday, January 10, 2022. The updated presentation includes, among other things, the Company's preliminary estimate that it sold approximately 3,454 bottles of NERLYNX® in the United States in the fourth quarter of 2021. This preliminary estimate is subject to completion of the Company's customary closing and review procedures and could change based on that process. The updated slides will be available on the Investors section of Puma's website at https://investor.pumabiotechnology.com/sec-filings/all-filings/default.aspx

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, provided an update to the corporate presentation that its Chief Executive Officer and President, Alan H. Auerbach, presented at the virtual H.C. Wainwright BioConnect Conference, which began at 7:00 a.m. EST on Monday, January 10, 2022. The updated presentation includes, among other things, the Company's preliminary estimate that it sold approximately 3,454 bottles of NERLYNX® in the United States in the fourth quarter of 2021. This preliminary estimate is subject to completion of the Company's customary closing and review procedures and could change based on that process. The updated slides will be available on the Investors section of Puma's website at https://investor.pumabiotechnology.com/sec-filings/all-filings/default.aspx.

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

    Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.

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  4. Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at the H.C. Wainwright BioConnect Virtual Conference. The presentation will be available on demand beginning at 7:00 a.m. EST on January 10, 2022.

    The presentation will be available for replay for 30 days on the Company's website at www.pumabiotechnology.com.

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral…

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at the H.C. Wainwright BioConnect Virtual Conference. The presentation will be available on demand beginning at 7:00 a.m. EST on January 10, 2022.

    The presentation will be available for replay for 30 days on the Company's website at www.pumabiotechnology.com.

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

    Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.

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    • Neratinib in combination with fulvestrant and trastuzumab offers promising results for patients with hormone receptor-positive, HER2-mutated metastatic breast cancer with prior exposure to CDK4/6 inhibitors
    • Neratinib in combination with trastuzumab results in strong activity in patients with triple negative metastatic breast cancer with a HER2 mutation

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, presented an update from its Phase II SUMMIT trial at the ongoing 2021 San Antonio Breast Cancer Symposium (SABCS) Annual Meeting. The data presented was from the cohort of patients with hormone receptor-positive, HER2-mutant metastatic breast cancer, exposed to CDK4/6 inhibitors, and treated with a combination of neratinib…

    • Neratinib in combination with fulvestrant and trastuzumab offers promising results for patients with hormone receptor-positive, HER2-mutated metastatic breast cancer with prior exposure to CDK4/6 inhibitors
    • Neratinib in combination with trastuzumab results in strong activity in patients with triple negative metastatic breast cancer with a HER2 mutation

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, presented an update from its Phase II SUMMIT trial at the ongoing 2021 San Antonio Breast Cancer Symposium (SABCS) Annual Meeting. The data presented was from the cohort of patients with hormone receptor-positive, HER2-mutant metastatic breast cancer, exposed to CDK4/6 inhibitors, and treated with a combination of neratinib with fulvestrant and trastuzumab and a separate cohort of patients with metastatic triple negative breast cancer with a HER2 mutation treated with the combination of neratinib plus trastuzumab. The presentation, entitled "Neratinib + fulvestrant + trastuzumab for hormone receptor-positive, HER2-mutant metastatic breast cancer and neratinib + trastuzumab for triple-negative disease: Latest updates from the SUMMIT trial," is being presented at an oral session (GS4-10) by Komal Jhaveri, MD, FACP, Medical Oncologist at Memorial Sloan Kettering Cancer Center, on December 10 at 11:00 a.m. CST. A copy of this oral presentation is available on the Puma Biotechnology website, https://www.pumabiotechnology.com.

    The Phase II SUMMIT trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating HER2 (ERBB2) mutations or lung cancers with EGFR exon 18 mutations (NCT01953926). In the HER2-mutant, hormone receptor (HR)-positive, metastatic breast cancer cohort, patients who have previously received CDK4/6 inhibitors were previously enrolled in a non-randomized cohort and received 240 mg of neratinib per day, 500 mg fulvestrant on day 1 and 15 of Cycle 1 and then 8mg/kg trastuzumab every 4 weeks initially and then 6mg/kg trastuzumab every 3 weeks thereafter. In the HER2-mutant, triple negative metastatic breast cancer (TNBC) cohort, patients received 240 mg of neratinib per day and 8mg/kg body weight trastuzumab initially and then 6mg/kg trastuzumab every 3 weeks. All patients received anti-diarrheal prophylaxis with loperamide alone for the first two treatment cycles.

    The SUMMIT trial was later amended to randomize hormone receptor-positive, HER2-mutant metastatic breast cancer patients to receive either: (i) the combination of neratinib (N), trastuzumab (T) and fulvestrant (F), (ii) the combination of fulvestrant and trastuzumab, or (iii) fulvestrant alone. Once randomized, patients received either neratinib plus fulvestrant plus trastuzumab, fulvestrant plus trastuzumab, or fulvestrant in 1:1:1 ratio. All patients received anti-diarrheal prophylaxis with loperamide alone for the first two treatment cycles.

    In the non-randomized cohort, for the 26 patients with HR+, HER2-mutated MBC who had previously received CDK4/6 inhibitors, the efficacy results showed that for the patients who received neratinib plus fulvestrant plus trastuzumab, 12 patients (46.2%) experienced a confirmed objective response, all of which were partial responses, and 15 patients (57.7%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response, or stable disease for at least 24 weeks). The median duration of response was 14.4 months and the median progression-free survival was 8.2 months (Table 1).

    For the randomized portion of the trial, for the patients with HR+, HER2-mutated MBC who had previously received CDK4/6 inhibitors, no patient in either the fulvestrant plus trastuzumab or fulvestrant alone arm experienced a confirmed objective response. In the 7 randomized patients who received the combination of neratinib, trastuzumab and fulvestrant, 2 patients (28.6%) experienced a confirmed objective response, including one complete response (14.3%) and one partial response (14.3%), and 2 patients (28.6%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 24 weeks). The median duration of response was not reached and the median progression-free survival was 6.2 months (Table 1).

    For all 33 patients with HR+, HER2-mutated MBC, who had previously received CDK4/6 inhibitors, who received the combination of neratinib plus trastuzumab plus fulvestrant, the efficacy results showed that 14 patients (42.4%) experienced a confirmed objective response, including one complete response (3.0%) and 13 partial responses (39.4%), and 17 patients (51.5%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 24 weeks). The median duration of response was 14.4 months and the median progression-free survival was 7.0 months (Table 1).

    Table 1: Efficacy findings from HR+ MBC patients

     
    Non-randomized Randomized Randomized Randomized All N+F+T
    (N+F+T, n=26) (N+F+T, n=7) (F+T, n=7) (F, n=7) (N+F+T, n=33)
    Objective response (confirmed CR/PR)a, n (%)

    12 (46.2)

     

    2 (28.6)

     

    0

     

    0

     

    14 (42.4)

    CR

    0

     

    1 (14.3)

     

    0

     

    0

     

    1 (3.0)

    PR

    12 (46.2)

     

    1 (14.3)

     

    0

     

    0

     

    13 (39.4)

     

     

     

     

     

     

     

     

     

    Best overall response

     

     

     

     

     

     

     

     

    (confirmed or unconfirmed PR or CR), n (%)

    15 (57.7)

     

    3 (42.9)

     

    0

     

    0

     

    18 (54.5)

     

     

     

     

     

     

     

     

     

    Median DORb, months (95% CI)

    14.4 (6.4–NE)

     

    NE

     

    NE

     

    NE

     

    14.4 (6.4–NE)

     

     

     

     

     

     

     

     

     

    Clinical benefitc, n (%)

    15 (57.7)

     

    2 (28.6)

     

    0

     

    0

     

    17 (51.5)

     

     

     

     

     

     

     

     

     

    Median PFS, months (95% CI)

    8.2 (4.0–15.1)

     

    6.2 (2.1–NE)

     

    3.9 (1.9–4.1)

     

    4.1 (1.6–4.1)

     

    7.0 (4.2–12.7)

     

     

     

     

     

     

     

     

     

    Median duration of treatment, months (range)

    8.7 (1.0–22.1)

     

    5.0 (0.7–13.2)

     

    3.5 (0.8–4.1)

     

    2.1 (0.7–4.1)

     

    6.5 (0.7–22.1)

     
    Note: Data cut-off: 10 September 2021. Tumor response based on: investigator tumor assessments (RECIST v1.1) for HR+ cohorts
    CR, confirmed response; PR, partial response; CI, confidence interval; DOR, duration of response; NE, not estimable; PFS, progression-free survival
    a Objective response defined as either a complete or partial response that is confirmed no less than 4-weeks after the criteria for response are initially met
    b Kaplan-Meier analysis
    c Clinical benefit is defined as confirmed CR or PR or stable disease (SD) for ≥24 weeks (within +/– 7-day visit window)

    Based on the results from the randomized portion of the trial, for patients with hormone receptor-positive, HER2-mutant metastatic breast cancer, the Independent Data Monitoring Committee (IDMC) recommended closing enrollment to the fulvestrant plus trastuzumab and fulvestrant alone arms of the trial and recommended continuing enrollment in the neratinib plus trastuzumab plus fulvestrant arm of the trial. To date, the Company has enrolled 19 additional patients in this triplet arm of the trial.

    For the 18 patients with HER2-mutant triple negative breast cancer (TNBC) who received fulvestrant plus trastuzumab, 6 patients (33.3%) experienced a confirmed objective response, including one complete response (5.6%) and 5 partial responses (27.8%), and 7 patients (38.9%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 24 weeks). The median duration of response has not been reached and the median progression-free survival was 6.2 months (Table 2).

    Table 2: Efficacy findings from TNBC patients

     
    TNBC
    (N+T, n=18)
    Objective response (confirmed CR/PR)a, n (%)

    6 (33.3)

    CR

    1 (5.6)

    PR

    5 (27.8)

     

    Best overall response

    (confirmed or unconfirmed PR or CR), n (%)

    7 (38.9)

     

    Median DORb, months (95% CI)

    NE

     

    Clinical benefitc, n (%)

    7 (38.9)

     

    Median PFS, months (95% CI)

    6.2 (2.1–8.2)

     

    Median duration of treatment, months (range)

    4.4 (0.3–15.4)

     
    Note: Data cut-off: 10 September 2021. Tumor response based on: investigator tumor assessments (RECIST v1.1 or modified PERCIST) for TNBC cohorts; TNBC cohort analysis ongoing
    CR, confirmed response; PR, partial response; CI, confidence interval; DOR, duration of response; NE, not estimable; PFS, progression-free survival
    a Objective response defined as either a complete or partial response that is confirmed no less than 4-weeks after the criteria for response are initially met
    b Kaplan-Meier analysis
    c Clinical benefit is defined as confirmed CR or PR or stable disease (SD) for ≥24 weeks (within +/– 7-day visit window)

    The safety profile observed in patients treated with neratinib in the SUMMIT study was consistent with that observed previously in metastatic patients with HER2 amplified tumors. The interim safety results of the study showed that the most frequently observed adverse event was diarrhea. For the 33 safety-evaluable HR-positive breast cancer patients who received the combination of neratinib plus trastuzumab plus fulvestrant, 15 patients (45.5%) reported grade 3 diarrhea. One patient (3.0%) permanently discontinued neratinib due to diarrhea. For the 18 safety-evaluable triple negative breast cancer patients who received the combination of neratinib plus trastuzumab, 3 patients (16.7%) reported grade 3 diarrhea. No patient permanently discontinued neratinib due to diarrhea.

    "For patients treated with CDK4/6 inhibitors without seeing tumor reversal, combination therapy with neratinib, fulvestrant and trastuzumab presents a promising new treatment option," said Dr. Jhaveri. "Neratinib is not only effective in treating early stage HER2-positive breast cancer but has been seen as being efficacious in helping combat secondary HER2 mutations as well."

    Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "We are pleased to see the activity of neratinib in both the hormone receptor-positive and triple negative breast cancer cohorts of the SUMMIT trial. We look forward to obtaining data from the 19 additional patients who have been enrolled post expansion of the neratinib plus trastuzumab plus fulvestrant arm of the randomized trial, as per the IDMC, which we anticipate we will be able to present in the first half of 2022."

    About HER2-Positive Breast Cancer

    Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

    About Puma Biotechnology

    Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early-stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

    Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.

    Important Safety Information Regarding NERLYNX® (neratinib) U.S. Indication

    NERLYNX® (neratinib) tablets, for oral use

    INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

    • As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
    • In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.

    CONTRAINDICATIONS: None

    WARNINGS AND PRECAUTIONS:

    • Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite dose escalation or loperamide, treat with loperamide, additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
    • Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
    • Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

    ADVERSE REACTIONS:

    The most common adverse reactions (reported in ≥ 5% of patients) were as follows:

    • NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.
    • NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

    To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS:

    • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids.
    • Strong CYP3A4 inhibitors: Avoid concomitant use.
    • P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.
    • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
    • Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX.

    USE IN SPECIFIC POPULATIONS:

    • Lactation: Advise women not to breastfeed.

    Please see Full Prescribing Information for additional safety information.

    To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

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