Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer
March 20 2024 - 8:30AM
Business Wire
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240320193286/en/
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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