LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company,
announced that it has submitted its Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA) for neratinib. The
potential indication is for the extended adjuvant treatment of
HER2-positive early stage breast cancer that has previously been treated
with trastuzumab (Herceptin®)-based adjuvant therapy. The submission is
based upon the ExteNET Phase III study, which reached its primary
endpoint whereby neratinib demonstrated a statistically significant
reduction of risk of invasive disease recurrence or death versus placebo.
"Although the use of trastuzumab in the adjuvant setting has led to a
reduction in disease recurrence in patients with early stage
HER2-positive breast cancer, there remains an unmet clinical need for
further improvement in outcome in order to attempt to further reduce
this risk of recurrence following trastuzumab therapy," said Alan H.
Auerbach, Chief Executive Officer and President of Puma. "Neratinib may
be able to provide this type of improvement to further help the patients
with this disease. We look forward to working with the CHMP/EMA during
their review of this submission. This submission marks the first step in
the broader global registration plan for neratinib and Puma is working
with the U.S. FDA on the U.S. NDA, the next submission currently
anticipated in mid-2016."
In the ExteNET study, treatment with neratinib resulted in a 33%
reduction of risk of invasive disease recurrence or death versus placebo
(hazard ratio = 0.67, p = 0.009). The 2-year invasive disease free
survival (DFS) rate for the neratinib arm was 93.9% and the 2-year DFS
rate for the placebo arm was 91.6%. For the pre-defined subgroup of
patients with hormone receptor positive disease, the results of the
trial demonstrated that treatment with neratinib resulted in a 49%
reduction of risk of invasive disease recurrence or death versus placebo
(hazard ratio = 0.51, p = 0.001). For the patients with hormone receptor
positive disease, the 2-year DFS rate for the neratinib arm was 95.4%
and the 2-year DFS rate for the placebo arm was 91.2%. Results of the
study were published online in The Lancet Oncology on February
10, 2016.
The most frequently observed adverse event for the neratinib-treated
patients was diarrhea, with approximately 39.9% of the neratinib-treated
patients experiencing grade 3 or higher diarrhea (1 patient (0.1%) had
grade 4 diarrhea). Patients who received neratinib in the ExteNET trial
did not receive any prophylaxis with antidiarrheal agents to prevent the
neratinib-related diarrhea. Interim results of a Phase II study of
neratinib monotherapy in patients with HER2-positive early stage breast
cancer who have previously been treated with adjuvant trastuzumab, where
patients received anti-diarrheal prophylaxis with loperamide,
demonstrated that treatment with prophylactic loperamide reduced the
rate of grade 3 or higher diarrhea to between 13.0% and 18.5%.
About ExteNET
The ExteNET trial is a double-blind, placebo-controlled, Phase III trial
of neratinib versus placebo after adjuvant treatment with trastuzumab
(Herceptin) in women with early stage HER2-positive breast cancer. The
trial randomized 2,840 patients in 41 countries with early stage
HER2-positive breast cancer who had undergone surgery and adjuvant
treatment with trastuzumab. After completion of adjuvant treatment with
trastuzumab, patients were randomized to receive extended adjuvant
treatment with either neratinib or placebo for a period of one year.
Patients were then followed for recurrent disease, ductal carcinoma in
situ (DCIS), or death for a period of two years after randomization in
the trial. The primary endpoint of the trial was DFS.
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 anticipated timing of regulatory filings. 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, 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,
2015. 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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