LOS ANGELES--(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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