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2024 News Releases
Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer
LOS ANGELES, Calif., March 20, 2024 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a
biopharmaceutical company (the Company), has been notified by the U.S. Food and Drug
Administration (FDA) that its Investigational New Drug Application (IND) submission has been
reviewed, and Puma can proceed with the clinical development of alisertib for the treatment of
patients with human epidermal growth factor receptor 2-negative (HER2-negative), hormone
receptor-positive metastatic breast cancer in Puma’s Phase II ALISCA-Breast1 trial (Study PUMA-
ALI-4201). This trial will investigate alisertib in combination with endocrine treatment (consisting
of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve
patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.
Patients must have been previously treated with CDK 4/6 inhibitors and received at least two prior
lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Puma
plans to initiate this trial in the second half of 2024.
Patients will be dosed with alisertib given at either 30 mg, 40 mg or 50 mg twice daily on days 1-3,
8-10 and 15-17 on a 28-day cycle in combination with the endocrine therapy of the investigator’s
choice. Patients must not have been previously treated with the endocrine treatment that will be
given in combination with alisertib in the trial. Each dose level will enroll up to 50 patients.
Patients must provide blood samples and tissue-based biopsies so that biomarkers can be evaluated.
The primary efficacy end points will include objective response rate, duration of response, disease
control rate and progression-free survival. As a secondary endpoint, the Company will be
evaluating each of these efficacy endpoints within biomarker subgroups in order to determine
whether any biomarker subgroup correlates with response. The goal would be to enhance the
efficacy in a biomarker subgroup to improve the efficacy of alisertib as previously seen in
preclinical and clinical studies in other cancers, including breast cancer and small cell lung cancer.
Once the optimal alisertib dose is identified, the Company plans to engage with global regulatory
agencies regarding the design of a pivotal (Phase III) trial, which it anticipates will be a randomized
trial of alisertib plus investigators choice endocrine therapy versus placebo plus investigator’s
choice endocrine therapy in patients with chemotherapy naïve HER2-negative, hormone receptor-
positive metastatic breast cancer.
“Although there have been new drugs approved for the treatment of ER-positive HER2-negative
metastatic breast cancer, there continues to be a need for new drugs and ones that specifically can
address patients who have been previously treated with CDK 4/6 inhibitors,” said Alvin Wong,
Pharm.D., Chief Scientific Officer of Puma Biotechnology. “The TBCRC 041 trial, which was
published in JAMA Oncology in March 2023, demonstrated that alisertib is among the first
investigational targeted therapies to have demonstrated encouraging clinical activity and have been
generally well tolerated in the setting of endocrine and CDK 4/6 inhibitor resistant metastatic breast
cancer. We look forward to the initiation of the ALISCA-Breast1 trial in the second half of 2024.”
Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are
excited to move forward with the development of alisertib in HER2-negative hormone receptor-
positive metastatic breast cancer. We believe that the data from TBCRC 041, which tested alisertib
alone and with fulvestrant, and the randomized trial of alisertib plus paclitaxel versus paclitaxel
alone have demonstrated that alisertib was active in patients with HER2-negative, hormone
receptor-positive metastatic breast cancer and in biomarker focused subgroups. We also recognize
our fiscal responsibility to the shareholders of the Company and will be carefully managing the
development expenses for alisertib so as not to potentially negatively impact the Company’s
profitability.”
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-licensed 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.
In September 2022, Puma entered into an exclusive license agreement for the development and
commercialization of the anti-cancer drug alisertib, an investigational, selective, small molecule,
orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of
alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma
initiated ALISCA-Lung 1, a Phase II clinical trial of alisertib monotherapy for the treatment of
patients with extensive-stage small cell lung cancer.
Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Puma’s
anticipated milestones and the development of alisertib. All forward-looking statements involve
risks and uncertainties that could cause Puma’s actual results to differ materially from the
anticipated results and expectations expressed in these forward-looking statements. These
statements are based on current expectations, forecasts and assumptions, and actual outcomes and
results could differ materially from these statements due to a number of factors, which include, but
are not limited to, the risk factors disclosed in the periodic and current reports filed by Puma with
the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent reports. Readers are cautioned
not to place undue reliance on these forward-looking statements, which speak only as of the date
hereof. Puma assumes no obligation to update these forward-looking statements, except as required
by law.
Contact:
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500
info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
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Los Angeles, CA 90024
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