LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, has expanded the second cohort from its Phase
II clinical trial of its lead drug candidate PB272 (neratinib) as a
single agent in patients with solid tumors who have an activating HER2
mutation (basket trial). The cohort that has been expanded is the cohort
that includes patients with metastatic non-small cell lung cancer and
whose tumors have a HER2 mutation.
The Phase II basket trial, which was initiated in October 2013, is an
open-label, multicenter, multinational study to evaluate the safety and
efficacy of PB272 administered daily to patients who have solid tumors
with activating (driver) ERBB mutations, including epidermal growth
factor receptor (EGFR), HER2 and HER3. The cohorts (baskets) included in
the study are (1) bladder/urinary tract cancer; (2) breast cancer; (3)
colorectal cancer; (4) endometrial cancer; (5) gastric/esophageal
cancer; (6) ovarian cancer; (7) all other solid tumors with a HER2
mutation; (8) EGFR mutated and/or amplified primary brain cancer; and
(9) solid tumors with a HER3 mutation. The non-small cell lung cancer
(NSCLC) patients initially entered the study in the “other solid tumors
with a HER2 mutation” basket and due to the preliminary activity seen in
the trial the Company has expanded the basket, as per the protocol for
the trial. The expanded HER2 mutant NSCLC basket will now enroll a total
of 18 patients.
Last year at the European Society for Medical Oncology (ESMO) 2014
Congress, Puma presented initial data from the Phase II clinical trial
of PB272 (neratinib) for the treatment of patients with NSCLC with
somatic HER2 mutations. The efficacy results from the trial showed that
for the 13 patients in the trial who received neratinib monotherapy, no
patient experienced a partial response, 7 (54%) patients achieved stable
disease and 4 (31%) patients achieved clinical benefit (defined as a
partial response or stable disease for 12 or more weeks). In addition,
the median progression free survival of the neratinib monotherapy arm
was 2.9 months. In that study, the majority of the patients had the YVMA
exon 20 mutation and there was less representation from other HER2
mutations. In the patients with NSCLC who have been treated in the
basket study thus far, a much more diverse and a broader representation
of HER2 mutations has been seen. The Company believes that although it
is early and difficult to draw definitive conclusions, it appears that
neratinib may be more selectively active in some HER2 mutated NSCLC
tumors compared to others, which may account for the difference in
activity being seen in the HER2 mutated NSCLC patients treated in the
basket trial compared to those treated in the prior trial. The Company
will continue to monitor this activity as the trial progresses.
“We are pleased to expand the second cohort in the basket trial.
Although it is early, we are pleased with the initial activity that we
are seeing in the patients with HER2 mutated non-small cell lung cancer
in the trial,” said Alan H. Auerbach, Chief Executive Officer and
President of Puma. “We look forward to continuing enrollment into this
initially expanded cohort and we look forward to expanding additional
cohorts from the basket trial, which we anticipate being able to do
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 anticipated timing for the expansion of additional
cohorts from the basket trial. 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. 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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