LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), today announced a publication in
the September 2015 issue of the Journal of the National Comprehensive
Cancer Network describes that a patient with HER2 non-amplified
(HER2-negative) metastatic breast cancer who also had a HER2 activating
mutation was successfully treated with PB272 (neratinib).
The peer-reviewed publication describes a female patient with advanced
stage IV invasive ductal carcinoma of the breast. After multiple
treatments with chemotherapy and hormonal therapy, a tumor specimen was
submitted to Foundation Medicine for comprehensive genomic profiling.
This testing identified a HER2 L755S mutation, an activating mutation
located in the tyrosine kinase inhibitor binding site of the HER2 kinase
domain. The L755S mutation produces resistance to the HER2 tyrosine
kinase inhibitor lapatinib, but in preclinical studies has been shown to
be highly sensitive to neratinib.
“Prior to treatment, the patient’s ECOG performance status deteriorated
and she was essentially homebound with massive ascites and profound
weakness,” said Dr. Noa Efrat Ben-Baruch, Head of the Department of
Oncology, Kaplan Medical Center, Rehovot, Israel and a co-author of the
publication. “The patient began treatment with neratinib and within two
months her performance status improved, she was able to resume normal
daily activities and a CT scan performed showed a partial response that
persisted for 11 months. Capecitabine was then added to neratinib and
the patient’s tumor again responded. This clinical response markedly
improved the patient’s performance status and quality of life. The
treatment of this patient is an excellent example of collaboration
between basic research, clinical application and biotechnology companies
for the benefit of patients. With the advent of molecular profiling of
patients with metastatic disease, such collaborations are of utmost
importance for the development of new drug candidates outside of formal
clinical trials.”
Dr. Ron Bose, from the Siteman Cancer Center and Washington University
School of Medicine and a co-author of the publication, added, “This case
is the first published report of a patient with HER2-mutated breast
cancer responding to treatment with a single-agent, HER2-targeted drug.
This also validates our previously published preclinical data with
neratinib that showed potent antitumor activity in HER2 mutations.
Additional study of neratinib in patients with HER2 mutations is clearly
warranted.”
“We are very pleased to see the activity of neratinib in this case
report,” said Alan H. Auerbach, Chief Executive Officer and President of
Puma. “We continue to be encouraged by the results of our ongoing
studies of neratinib in patients with HER2 mutations, including our
ongoing trials in breast cancer, lung cancer and the basket study, and
we look forward to sharing more information about these trials later
this year.”
About Puma Biotechnology
Puma Biotechnology, Inc. is a development stage biopharmaceutical
company that acquires and develops innovative products for the treatment
of various forms of cancer. The Company focuses on in-licensing drug
candidates that are undergoing or have already completed initial
clinical testing for the treatment of cancer and then seeks to further
develop those drug candidates for commercial use. The Company is
initially focused on the development of PB272 (oral neratinib), a potent
irreversible tyrosine kinase inhibitor, for the treatment of patients
with HER2-positive breast cancer and patients with non-small cell lung
cancer, breast cancer and other solid tumors that have a HER2 mutation.
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 announcement of data relative to the Company’s
clinical 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;
the Company's dependence on licensed intellectual property; and the
other risk factors disclosed in the periodic 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, 2014 and Quarterly Report on Form 10-Q for the quarter
ended June 30, 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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