Puma Biotechnology Announces Initiation of ALISCA-Lung1 Phase II Trial of Alisertib in Small Cell Lung Cancer
13 2월 2024 - 10:30PM
Business Wire
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced the initiation of its ALISertib in CAncer
(ALISCA-Lung1) Phase II trial (PUMA-ALI-4201; NCT06095505) of
alisertib monotherapy for the treatment of patients with extensive
stage small cell lung cancer. The ALISCA-Lung1 trial will enroll up
to 60 patients with extensive stage small cell lung cancer who have
progressed on or after first-line platinum-based chemotherapy and
immunotherapy. Patients must provide tissue specimens so that
biomarkers can be analyzed. Alisertib is dosed at 50 mg BID on days
1-7 of every 21-day cycle.
The primary endpoint of the trial is objective response rate,
with secondary endpoints of duration of response, disease control
rate, progression-free survival and overall survival. Puma will
also be looking at each of these endpoints within selected
pre-specified biomarker subgroups and will assess whether there is
enhanced efficacy in any biomarker subgroup. Puma will be
performing its biomarker analysis of the ALISCA-Lung1 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 efficacy. Based upon the
outcomes of the study, Puma anticipates meeting with the U.S. Food
and Drug Administration 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, Marlene and
Stewart Greenbaum Professor of Oncology in the Department of
Medicine at the University of Maryland, Baltimore. “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 initiate 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 expectations regarding the
development of alisertib and clinical trials involving 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/20240213029980/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
Puma Biotechnology (NASDAQ:PBYI)
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Puma Biotechnology (NASDAQ:PBYI)
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