LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company,
announced the presentation of positive results from an ongoing Phase II
clinical trial (Translational Breast Cancer Research Consortium TBCRC
022) of Puma's investigational drug PB272 (neratinib) for the treatment
of HER2-positive metastatic breast cancer that has metastasized to the
brain. The data were presented today in an oral presentation at the
American Society of Clinical Oncology (ASCO) 2017 Annual Meeting in
Chicago, Illinois.
The multicenter Phase II clinical trial enrolled patients with
HER2-positive metastatic breast cancer who have brain metastases. The
trial is being performed by the TBCRC and enrolled three cohorts of
patients. Patients in the first cohort (n=40) included those with
progressive brain metastases who were administered neratinib
monotherapy. Data from this cohort were previously reported at the 2014
ASCO Annual Meeting and published in the Journal of Clinical Oncology in
2016. Patients in the second cohort (n=5) represent patients who had
brain metastases which were amenable to surgery and who were
administered neratinib monotherapy prior to and after surgical
resection. The third cohort (target enrollment=60) enrolled two
sub-groups of patients (prior lapatinib-treated and no prior lapatinib)
with progressive brain metastases who were administered neratinib in
combination with the chemotherapy drug capecitabine. The oral
presentation reflects only the patients in the third cohort of patients
without prior lapatinib exposure (cohort 3A, n=37), who all had
progressive brain metastases at the time of enrollment and who received
the combination of capecitabine plus neratinib. A full copy of the oral
presentation that was presented at the ASCO Annual Meeting is available
on the Puma Biotechnology website. Results from the second cohort and
cohort 3B (prior lapatinib-treated) will be presented at a forthcoming
medical meeting.
In cohort 3A, 30% of the patients had received prior craniotomy, 65% of
the patients had received prior whole brain radiotherapy (WBRT), and 35%
had received prior stereotactic radiosurgery (SRS) to the brain. No
patients had received prior treatment with lapatinib.
The primary endpoint of the trial was central nervous system (CNS)
Objective Response Rate according to a composite criteria that included
volumetric brain MRI measurements, steroid use, neurological signs and
symptoms, and RECIST evaluation for non-CNS sites. The secondary
endpoint of the trial was CNS response by Response Assessment in
Neuro-Oncology-Brain Metastases (RANO-BM) Criteria. The efficacy results
from the trial showed that 49% of patients experienced a CNS Objective
Response by the composite criteria. The results also showed that the CNS
response rate using the RANO-BM criteria was 24%. The median time to CNS
progression was 5.5 months and the median overall survival was 13.5
months, though 49% of patients remain alive and survival data are
immature.
The results for cohort 3A showed that the most frequently observed
severe adverse event for the 37 patients evaluable for safety was
diarrhea. Patients received antidiarrheal prophylaxis consisting of high
dose loperamide, given together with the combination of capecitabine
plus neratinib for the first cycle of treatment in order to try to
reduce the neratinib-related diarrhea. Among the 37 patients evaluable
for safety, 32% of the patients had grade 3 diarrhea and 41% had grade 2
diarrhea.
“Neratinib given in combination with capecitabine showed promising
activity in patients with heavily pre-treated HER2-positive disease
metastatic to the CNS,” said Rachel A. Freedman, MD, MPH, Breast
Oncology Center, Susan F. Smith Center for Women's Cancers, Dana-Farber
Cancer Institute. “Despite the introduction of several new treatments
for patients with HER2-positive metastatic breast cancer, CNS
progression events remain a major source of patient morbidity and
mortality. Based on the results from TBCRC-022, we look forward to
additional trials with neratinib-based regimens for HER2-positive CNS
disease.”
“We are very pleased with the activity seen in this trial with the
combination of neratinib plus capecitabine,” said Alan H. Auerbach, CEO
and President of Puma Biotechnology. “As a small molecule that can cross
the blood brain barrier, neratinib potentially offers patients with
HER2-positive metastatic breast cancer that has metastasized to the CNS
a novel HER2 targeted treatment option. We look forward to working with
TBCRC on future trials of neratinib in patients with HER2-positive
disease metastatic to the CNS.”
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
statements regarding the development and potential benefits of the
Company’s drug candidates, the Company’s clinical trials and the
announcement of data relative to these 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, risks pertaining to securities class action, derivative and
defamation lawsuits, 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, 2016. 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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