LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company,
announced that results from the NEfERT-T Phase II clinical trial of
neratinib in ERBB2-positive metastatic breast cancer patients were
published online in JAMA Oncology. The article, entitled
“Neratinib Plus Paclitaxel vs. Trastuzumab Plus Paclitaxel in Previously
Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T
Randomized Clinical Trial,” appears in the April 14, 2016 online issue
and will be published in a future print issue of the journal.
The NEfERT-T trial is a randomized, two-arm Phase II trial of neratinib
plus the anticancer drug paclitaxel versus trastuzumab (Herceptin) plus
paclitaxel as a first-line treatment for ERBB2-positive (previously
referred to as HER2-positive) locally recurrent or metastatic breast
cancer. The trial enrolled 479 patients in 33 countries who had not
received prior anticancer therapy for locally recurrent or metastatic
disease. Patients were randomized to receive first-line treatment with
either paclitaxel plus neratinib or paclitaxel plus trastuzumab. The
primary endpoint of the trial was progression-free survival (PFS). The
secondary endpoints of the study included objective response rate (ORR)
and the incidence of central nervous system (CNS) metastases, including
brain metastases.
The results of the trial demonstrated that the progression-free survival
for the patients who received the combination of paclitaxel plus
neratinib was 12.9 months and the progression-free survival for the
patients who received the combination of paclitaxel plus trastuzumab was
12.9 months (hazard ratio 1.02, p=0.89). The objective response rate in
the trial for the patients who received the combination of paclitaxel
plus neratinib was 74.8% and the objective response rate for the
patients who received the combination of paclitaxel plus trastuzumab was
77.6% (p=0.52).
With respect to the incidence of CNS metastases (e.g., brain
metastases), treatment with the combination of paclitaxel plus neratinib
resulted in a 52% reduction in the incidence of CNS metastases compared
to the incidence of CNS metastases in patients who received the
combination of paclitaxel plus trastuzumab. Symptomatic or progressive
CNS recurrences occurred in 20 patients (8.3%) in the
neratinib-paclitaxel group and 41 patients (17.3%) in the
trastuzumab-paclitaxel group (relative risk 0.48, p=0.002). The
estimated Kaplan-Meier 2-year incidence of CNS recurrences was 16.3% in
the neratinib-paclitaxel group and 31.2% in the trastuzumab-paclitaxel
group (hazard ratio 0.45, p=0.004). These results reflect a
statistically significant difference between the two treatment arms.
“The NEfERT-T trial represents the first randomized trial with a
HER2-targeted agent that has shown a statistically significant reduction
in the incidence of CNS metastases,” said Alan H. Auerbach, Chief
Executive Officer and President. “We believe this provides a meaningful
point of differentiation for neratinib in the treatment of HER2-positive
breast cancer. We are pleased that JAMA Oncology has chosen to
publish these results.”
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, but
not limited to, statements regarding the publication of clinical trial
results. 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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