Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib for HER2 (ERBB2) Mutant, Metastatic C...
March 18 2019 - 3:45PM
Business Wire
Oral Plenary Presentation Receives SGO
Presidential Award
Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, announced today that updated results from the cervical
cancer cohort of SUMMIT, an ongoing Phase II basket trial examining
the efficacy of neratinib in HER2-mutated cancers, were reported at
the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting in
Honolulu, Hawaii. “Neratinib in patients with HER2-mutant,
metastatic cervical cancer: findings from the phase II SUMMIT
‘basket’ trial,” was presented during the Scientific Plenary
Session by Anishka D’Souza, M.D., Assistant Professor of Clinical
Medicine, Keck School of Medicine of University of Southern
California (USC). SGO selected this abstract as the recipient of
the 2019 SGO Presidential Award. Slides from the presentation are
available on the Puma Biotechnology website.
The Phase II SUMMIT ‘basket’ trial is an open-label,
multicenter, multinational study to evaluate the safety and
efficacy of neratinib administered daily to patients who have solid
tumors with activating, somatic HER2 mutations. The cervical cancer
cohort was comprised of 11 patients with advanced and/or metastatic
disease treated with neratinib monotherapy. Patients received a
median of 2 (range 1–4) prior regimens in the recurrent or
metastatic setting before entering this trial. Six patients (54.5%)
had been previously treated with bevacizumab prior to entering the
study; 7 patients (63.6%) had received prior surgery; and 9
patients (81.8%) received prior radiation therapy. The objective
response rate was 27.3% (95% CI: 6.0%–61.0%). The clinical benefit
rate was 54.5% (95% CI: 23.4%–83.3%) and included 3 patients with
confirmed partial responses and 3 patients with stable disease that
lasted greater than 16 weeks. The median progression free survival
was 7.0 months (95% CI: 0.7–20.1 months).
The safety profile observed in neratinib-treated cervical cancer
patients in SUMMIT was consistent with that reported for
HER2-amplified metastatic breast cancer. The most frequently
observed adverse event was diarrhea, any grade (n=9, 81.8%)
including 1 (9%) grade 3 diarrhea event. The duration of grade 3
diarrhea was 1 day. None of the diarrhea events resulted in dose
reduction, dose discontinuation or hospitalization.
“Somatic HER2 mutations represent a distinct class of oncogenic
driver mutations that appear to be clinically actionable for
metastatic cervical cancers. Treatment with neratinib led to
durable responses and disease control in metastatic patients with
HER2-mutant cervical cancer,” said Dr. D’Souza, who practices
oncology at the USC Norris Comprehensive Cancer Center.
Alan H. Auerbach, CEO and President of Puma Biotechnology,
added, “We are very pleased with the activity seen with neratinib
in this cohort of patients with HER2-mutated cervical cancer. We
look forward to the further development of neratinib in this
patient population.”
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 development of Puma’s product
candidates. 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 periodic and current 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, 2018. 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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version on businesswire.com: https://www.businesswire.com/news/home/20190318005065/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1-424-248-6500info@pumabiotechnology.comir@pumabiotechnology.com
David Schull or Alex Fudukidis, Russo Partners,
+1-212-845-4271david.schull@russopartnersllc.comalex.fudukidis@russopartnersllc.com
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