Puma Biotechnology Completes Targeted Enrollment in Neratinib Phase III Metastatic Breast Cancer Trial
July 06 2017 - 4:15PM
Business Wire
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced that targeted patient enrollment in the Phase
III NALA trial of the Company's lead drug candidate PB272
(neratinib) in patients with HER2-positive metastatic breast cancer
who have failed two or more prior lines of HER2-directed treatments
(third-line disease) in the setting of metastatic disease has been
completed.
The Phase III NALA trial is a randomized trial of PB272 plus
Xeloda versus Tykerb plus Xeloda in patients with third-line
HER2-positive metastatic breast cancer. The trial has enrolled
approximately 600 patients who are randomized (1:1) to receive
either PB272 plus Xeloda or Tykerb plus Xeloda. The trial is being
conducted at sites in North America, Europe and Asia-Pacific. The
co-primary endpoints of the trial are progression free survival
(PFS) and overall survival (OS). The company reached agreement with
the U.S. Food and Drug Administration (FDA) under a Special
Protocol Assessment (SPA) for the design of the Phase III clinical
trial and the European Medicines Agency (EMA) has also provided
follow-on scientific advice (SA) consistent with that of the FDA
regarding the Company's Phase III trial design and endpoints used
in the trial.
The primary analyses of PFS and OS are event driven. The Company
anticipates that primary analysis of PFS will be available during
the first half of 2018.
Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, said, "We are very pleased to achieve this important
milestone for the Phase III NALA trial of neratinib in
HER2-positive metastatic breast cancer. We look forward to
reporting initial data from the study, which we anticipate will
occur during the first half of 2018. We also look forward to the
continued development of neratinib in combination with Kadcyla in
HER2-positive metastatic breast cancer (FB-10 trial), in patients
with HER2-positive breast cancer that has metastasized to the brain
(TBCRC-022 trial) and in patients with HER2 non-amplified tumors
that have a HER2 mutation (SUMMIT)."
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. The Company in-licenses the global
development and commercialization rights to three drug
candidates—PB272 (neratinib (oral)), PB272 (neratinib
(intravenous)) and PB357. Neratinib is a potent irreversible
tyrosine kinase inhibitor that blocks signal transduction through
the epidermal growth factor receptors, HER1, HER2 and HER4.
Currently, the Company is primarily focused on the development of
the oral version of neratinib, and its most advanced drug
candidates are directed at the treatment of HER2-positive breast
cancer. The Company believes that neratinib has clinical
application in the treatment of several other cancers as well,
including non-small cell lung cancer and other tumor types that
over-express or have a mutation in HER2.
Further information about Puma Biotechnology can be found at
www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the Company’s clinical trials and
the announcement of data relative to these trials. All
forward-looking statements included in this press release involve
risks and uncertainties that could cause the Company'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 fact that the Company has no
product revenue and no products approved for marketing, the
Company's dependence on PB272, which is still under development and
may never receive regulatory approval, the challenges associated
with conducting and enrolling clinical trials, the risk that the
results of clinical trials may not support the Company's drug
candidate claims, even if approved, the risk that physicians and
patients may not accept or use the Company's products, the
Company's reliance on third parties to conduct its clinical trials
and to formulate and manufacture its drug candidates, risks
pertaining to securities class action, derivative and defamation
lawsuits, the Company's dependence on licensed intellectual
property, and the other risk factors disclosed in the periodic and
current reports filed by the Company with the Securities and
Exchange Commission from time to time, including the Company's
Annual Report on Form 10-K for the year ended December 31, 2016.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
The Company assumes no obligation to update these forward-looking
statements, except as required by law.
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version on businesswire.com: http://www.businesswire.com/news/home/20170706005338/en/
Puma Biotechnology, Inc.Alan H. Auerbach or Mariann Ohanesian,
+1 424 248
6500info@pumabiotechnology.comir@pumabiotechnology.comorRusso
PartnersAmiad Finkelthal or David Schull, +1 212 845
4200amiad.finkelthal@russopartnersllc.comdavid.schull@russopartnersllc.com
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