Puma Biotechnology Expands Cohort in Phase II SUMMIT Trial of PB272 in HER2 Mutation-Positive Cancer Patients
January 06 2017 - 8:15AM
Business Wire
Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, has expanded the fourth cohort from its Phase II SUMMIT
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 cervical cancer
and whose tumors have a HER2 mutation.
The Phase II SUMMIT basket trial is an open-label, multicenter,
multi-histology, international study to evaluate the safety and
efficacy of PB272 administered daily to patients who have solid
tumors with activating ERBB mutations including EGFR, HER2 and
HER3. The cohorts included in the basket study receiving neratinib
monotherapy are hormone receptor-negative breast cancer; biliary
tract cancers; endometrial cancer; gastric/esophageal cancer;
ovarian cancer; and all other solid tumors with a HER2 mutation.
The cohorts receiving combination treatment are hormone
receptor-positive breast cancer (neratinib plus fulvestrant) and
bladder cancer (neratinib plus paclitaxel). The cervical cancer
patients initially entered the study in the “other solid tumors
with a HER2 mutation” cohort, and due to the preliminary activity
seen in the trial, the Company has expanded a separate cervical
cancer cohort pursuant to the protocol for the trial. The expanded
HER2-mutant cervical cancer cohort will now enroll a total of 18
patients.
Dr. David Hyman, Director, Developmental Therapeutics at
Memorial Sloan Kettering Cancer Center and principal investigator
of the trial, stated, “We are pleased to expand our evaluation of
neratinib in metastatic cervical cancer, an orphan and deadly
disease with few treatment options. We believe this once again
demonstrates the value of the basket study approach, in particular
for developing targeted therapy for rare diseases with
clinically-actionable mutations. We look forward to presenting the
full results of the SUMMIT trial at a medical meeting in 2017.”
“We are pleased to expand the fourth cohort in the basket
trial,” said Alan H. Auerbach, Chief Executive Officer and
President of Puma. “Although it is early, we are pleased with the
initial activity that we are seeing in the patients with HER2
mutated cervical cancer in the trial. We look forward to continuing
enrollment into this expanded cohort and look forward to presenting
the full results from the SUMMIT study in 2017.”
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 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, 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, 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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version on businesswire.com: http://www.businesswire.com/news/home/20170106005098/en/
Puma Biotechnology, Inc.Alan H. Auerbach or Mariann Ohanesian,
+1 424 248
6500info@pumabiotechnology.comir@pumabiotechnology.comorRusso
PartnersDavid Schull or Darren Chia, +1 212 845
4226david.schull@russopartnersllc.comDarren.chia@russopartnersllc.com
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