Puma Biotechnology Announces FDA Clearance of IND for Alisertib in Small Cell Lung Cancer
08 8월 2023 - 9:30PM
Business Wire
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, has been notified by the U.S. Food and Drug Administration
(FDA) that its Investigational New Drug (IND) submission has been
reviewed, and Puma can proceed with the clinical development of
alisertib monotherapy for the treatment of patients with extensive
stage small cell lung cancer (SCLC). Puma’s Phase II trial (Study
PUMA-ALI-4201) will enroll up to 60 patients with extensive stage
small cell lung cancer who have progressed after first-line
platinum-based chemotherapy and immunotherapy. Patients must
provide tissue-based biopsies so that biomarkers can be analyzed.
Alisertib will be dosed at 50 mg BID on days 1-7 of every 21 day
cycle. The Company anticipates initiating the Phase II trial in the
second half of 2023.
The primary endpoint of the trial will be objective response
rate with secondary endpoints of duration of response, disease
control rate, progression free survival and overall survival. The
Company will also be looking at each of these endpoints within
selected pre-specified biomarker subgroups as well as to assess
whether there is enhanced efficacy in any biomarker subgroup. Puma
will be performing its biomarker analysis of the ALI-4201 trial in
parallel with the execution of the clinical trial. Puma plans to
perform an initial interim analysis for the evaluation of the
biomarkers as well as an evaluation of the efficacy. Based upon the
outcomes of the study, the Company anticipates meeting with the FDA
to explore the potential for an accelerated approval pathway for
alisertib in small cell lung cancer.
“Treatment options for patients with small cell lung cancer that
has progressed on or after platinum-based chemotherapy are limited,
and there is an urgent need for new drugs to treat this patient
population,” said Taofeek K. Owonikoko, MD, PhD, Chief of the
Division of Hematology/Oncology and Associate Director for
Translational Research and Co-Leader of the Cancer Therapeutics
Program at the UPMC Hillman Cancer Center. “The results from the
previous clinical trials of alisertib in small cell lung cancer
suggest that the drug may represent a potentially promising
treatment option for these patients and, more specifically, for
patient subsets whose tumors harbor potential molecular markers
that are likely associated with the clinical activity of an aurora
kinase A inhibitor such as alisertib,” said Dr. Owonikoko.
Alan H. Auerbach, Chief Executive Officer, President and Founder
of Puma, stated, “We are pleased to move forward with the clinical
development of alisertib in small cell lung cancer. We are eagerly
awaiting the start of this Phase II trial, and we hope that the
study will provide much needed insight into the clinical activity
of alisertib in small cell lung cancer and, more specifically, in
patients with molecularly defined tumors that may be targetable
with an aurora kinase A inhibitor like alisertib.”
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, a 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.
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, 2022 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/20230808140471/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull, +1 212 845 4200
david.schull@russopartnersllc.com
Puma Biotechnology (NASDAQ:PBYI)
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Puma Biotechnology (NASDAQ:PBYI)
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