Five Prime Therapeutics Provides Update on Phase 2 Trial of Cabiralizumab Combined with Opdivo® in Pancreatic Cancer
February 18 2020 - 9:25AM
Business Wire
Phase 2 Trial of Cabiralizumab plus Opdivo
(nivolumab) with and without Chemotherapy in Advanced Pancreatic
Cancer Did not Meet Primary Endpoint
Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage
biotechnology company focused on developing immune modulators and
precision therapies for solid tumor cancers, today announced that
Bristol-Myers Squibb informed the company that the randomized Phase
2 trial testing the combination of cabiralizumab with Opdivo®
(nivolumab) with and without chemotherapy in patients with advanced
pancreatic cancer did not meet its primary endpoint. While
Bristol-Myers Squibb has no near term plans for additional
sponsored development of cabiralizumab, Bristol-Myers Squibb will
continue to support the evaluation of cabiralizumab in select,
ongoing investigator-sponsored trials and may continue to assess
future development opportunities for the investigational asset.
Bristol-Myers Squibb also informed the company that no new safety
signals were observed in the Phase 2 trial.
“Pancreatic cancer is a difficult disease to treat, and
unfortunately the combination of cabiralizumab and Opdivo with and
without chemotherapy did not show any meaningful benefit over
standard of care chemotherapy in this randomized, controlled Phase
2 trial,” said Helen Collins, M.D., Executive Vice President and
Chief Medical Officer of Five Prime Therapeutics. “We are
disappointed by this outcome and appreciate the participation of
the investigators, staff, patients, caregivers, and our development
partner who all contributed to the conduct and completion of this
Phase 2 clinical trial.”
The multi-arm, randomized, controlled Phase 2 clinical trial
(NCT03336216) enrolled approximately 160 patients with locally
advanced or metastatic pancreatic cancer that has progressed during
or after one line of chemotherapy.
About Five Prime Therapeutics
Five Prime Therapeutics, Inc. develops innovative protein
therapeutics to improve the lives of patients with cancer. The
company focuses on developing immune modulators and precision
therapies for solid tumor cancers paired with companion diagnostics
to identify patients who are most likely to benefit from treatment
with Five Prime’s product candidates. The company’s product
candidates have innovative mechanisms of action and address patient
populations in need of better therapies. Five Prime has entered
into strategic collaborations with leading global pharmaceutical
companies and has promising product candidates in clinical and
preclinical development. For more information, please visit
www.fiveprime.com.
About Cabiralizumab (FPA008)
Cabiralizumab is an investigational antibody that inhibits the
CSF-1 receptor and has been shown in preclinical models and
clinical studies to block the activation and survival of monocytes
and macrophages. Inhibition of CSF1R in preclinical models of
several cancers reduces the number of immunosuppressive
tumor-associated macrophages (TAMs) in the tumor microenvironment,
thereby facilitating an immune response against tumors.
Bristol-Myers Squibb acquired rights in October 2015 to
cabiralizumab under an exclusive worldwide license and
collaboration agreement.
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "expect," "plan," "anticipate,"
"estimate," "intend" and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These forward-looking statements are based on Five Prime's
expectations and assumptions as of the date of this press release.
Each of these forward-looking statements involves risks and
uncertainties. Actual results may differ materially from these
forward-looking statements. Many factors may cause differences
between current expectations and actual results including
unexpected safety or efficacy data observed during preclinical or
clinical studies, changes in expected or existing competition,
changes in the regulatory, pricing or reimbursement environment,
and unexpected litigation or other disputes. Other factors that may
cause actual results to differ from those expressed or implied in
the forward-looking statements in this press release are discussed
in Five Prime’s filings with the U.S. Securities and Exchange
Commission, including the “Risk Factors” contained therein. Except
as required by law, Five Prime assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
Source: Five Prime Therapeutics, Inc.
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Five Prime Therapeutics Media and Investor Contact Martin
Forrest VP, Investor Relations & Corporate Communications Five
Prime Therapeutics, Inc. 415-365-5625
martin.forrest@fiveprime.com
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