Item 8.01 Other Events.
On August 22, 2016, Puma Biotechnology, Inc. (the "Company") announced that the
Marketing Authorization Application ("MAA") for neratinib has been validated by
the European Medicines Agency ("EMA"). Validation of the MAA confirms that the
submission is complete and starts the EMA's formal review process. The potential
indication for neratinib 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 MAA 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.
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%.
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, or death for a period of two years after randomization in the trial. The
primary endpoint of the trial was DFS.
This Current Report on Form 8-K contains forward-looking statements, including
statements regarding the potential benefits of neratinib and the MAA for
neratinib in Europe for the potential indication for the extended adjuvant
treatment of HER2-positive early stage breast cancer that has previously been
treated with trastuzumab (Herceptin®)-based adjuvant therapy. All
forward-looking statements included in this Current Report on Form 8-K 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
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
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