LOS ANGELES--(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.
Contact: