LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company,
announced that results from the subgroup of patients with hormone
receptor positive (HR-positive) breast cancer from the Company’s Phase
III ExteNET Trial of neratinib for early stage HER2-Amplified breast
cancer are being presented at the 2018 San Antonio Breast Cancer
Symposium (SABCS) that is currently taking place in San Antonio, Texas.
The presentation entitled, “Efficacy of neratinib in hormone
receptor-positive patients who initiated treatment within 1 year of
completing trastuzumab-based adjuvant therapy in HER2+ early stage
breast cancer: subgroup analyses from the phase III ExteNET trial,” is
being presented at a poster session by Dr. Frankie Ann Holmes, Texas
Oncology/US Oncology Research, Houston Texas on Thursday, December 6
from 7:00 - 9:00 a.m. CST. A copy of this poster is posted on Puma’s
website at www.pumabiotechnology.com.
In September 2018, the European Commission (EC) granted marketing
authorisation for NERLYNX® (neratinib) for the extended adjuvant
treatment of adult patients with early stage hormone receptor positive
HER2-overexpressed/amplified breast cancer and who are less than one
year from the completion of prior adjuvant trastuzumab based therapy.
This poster presentation highlights the data that was the basis for the
EC approval.
ExteNET was a Phase III multicenter, randomized, double-blind,
placebo-controlled trial of neratinib in adult patients (n=2,840) with
early stage HER2-positive breast cancer following adjuvant trastuzumab
treatment. Participants were randomized to receive either neratinib
(n=1420) or placebo (n=1420) for one year.
In the subgroup of 1334 patients with hormone receptor positive disease
and who were less than one year from the completion of prior adjuvant
trastuzumab based therapy, the data, presented in the poster,
demonstrated that after two years of follow-up, invasive disease-free
survival (iDFS) was 95.3% in the patients treated with neratinib
compared with 90.8% in those receiving placebo (hazard ratio = 0.49; 95%
CI: (0.30, 0.78); p=0.002). The presentation also showed that after five
years of follow-up, invasive disease-free survival (iDFS) was 90.8% in
the patients treated with neratinib compared with 85.7% in those
receiving placebo (hazard ratio = 0.58; 95% CI: (0.41, 0.82); p=0.002).
The poster highlighted that in this same subgroup, distant disease-free
survival (DDFS) was 96.1% in the patients treated with neratinib
compared with 92.9% in those receiving placebo (hazard ratio = 0.53, 95%
CI: (0.31, 0.88); p=0.015) after two years of follow-up. After five
years of follow-up, distant disease-free survival (DDFS) was 92.4% in
the patients treated with neratinib compared with 87.7% in those
receiving placebo (hazard ratio = 0.57; 95% CI: (0.39, 0.83); p=0.003).
Additionally, in this population, there were 295 patients who did not
achieve a pathological complete response (pCR) after treatment with
neoadjuvant therapy. This exploratory subgroup is similar to the patient
population in the Phase III KATHERINE trial of Kadcyla. The data
presented demonstrated that in this subgroup, after two years of
follow-up, invasive disease-free survival (iDFS) was 89.9% in the
patients treated with neratinib compared with 85.2% in those receiving
placebo (hazard ratio = 0.64; 95% CI: (0.30, 1.29)). Longer term follow
up demonstrated that at five years, invasive disease-free survival
(iDFS) was 85.0% in the patients treated with neratinib compared with
77.6% in those receiving placebo (hazard ratio = 0.60; 95% CI: (0.33,
1.07)).
The profile and frequency of treatment-emergent adverse events in this
subgroup of patients with hormone receptor positive disease and who are
less than one year from the completion of prior adjuvant trastuzumab was
similar compared with the overall safety population. The most common
grade 3 treatment-emergent adverse events in this subgroup were diarrhea
(neratinib, 39% vs placebo, 1%), nausea (1% vs <1%), and fatigue (2% vs
<1%); rates in the overall safety population were diarrhea (neratinib,
40% [included one grade 4 event] vs placebo, 2%), nausea (2% vs <1%),
and fatigue (2% vs <1%).
“Reducing the risk of disease recurrence remains a need for patients,
despite advances in the treatment of early stage HER2-positive breast
cancer,” said Professor Michael Gnant, Department of Surgery, Medical
University of Vienna, Austria. “This analysis shows that we may be able
to provide this type of improvement with neratinib to further reduce
this risk of recurrence.”
Puma Biotechnology CEO and President Alan H. Auerbach added, “We are
encouraged by the data in this patient population and we are committed
to continuing to expand NERLYNX accessibility to patients worldwide. We
expect NERLYNX to be commercially available in Europe in 2019, beginning
with our launch in Germany during the first half of 2019 and followed by
additional countries throughout Europe in the second half of 2019.”
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. Puma in-licenses the global development and
commercialization rights to three drug candidates — PB272 (neratinib,
oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was
approved by the U.S. Food and Drug Administration in July 2017 for the
extended adjuvant treatment of adult patients with early stage
HER2-overexpressed/amplified breast cancer, following adjuvant
trastuzumab-based therapy, and is marketed in the United States as
NERLYNX® (neratinib) tablets. NERLYNX was granted marketing
authorization by the European Commission for the extended adjuvant
treatment of hormone receptor-positive HER2-positive early stage breast
cancer in September 2018. NERLYNX is a registered trademark of Puma
Biotechnology, Inc.
Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding the benefits of NERLYNX® and neratinib and the
timing for commercial launch of NERLYNX® in Europe. All forward-looking
statements involve risks and uncertainties that could cause Puma’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 risk factors disclosed in the reports filed by Puma with
the Securities and Exchange Commission from time to time, including
Puma’s Annual Report on Form 10-K for the year ended December 31, 2017.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. Puma
assumes no obligation to update these forward-looking statements, except
as required by law.
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