Five Prime Therapeutics Announces Publication of the Phase 1 Bemarituzumab Study in the Journal of Clinical Oncology
March 13 2020 - 9:25AM
Business Wire
Phase 1 data illustrates the therapeutic
potential of bemarituzumab as a novel approach to treating patients
with FGFR2b-overexpressing gastric and gastroesophageal junction
adenocarcinoma (GEA)
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 the
publication of results from the phase 1 escalation and expansion
study of bemarituzumab in patients with advanced solid tumors and
FGFR2b-selected gastroesophageal adenocarcinoma in the digital
edition of the Journal of Clinical Oncology.
The purpose of the phase 1 trial was to evaluate the safety,
pharmacokinetics, and preliminary activity of single-agent
bemarituzumab in patients with FGFR2b-overexpressing GEA.
Seventy-nine patients were enrolled in the trial and no
dose-limiting toxicities were reported. Bemarituzumab was well
tolerated and the most frequent treatment-related adverse events
(TRAEs) were fatigue, nausea, and dry eye. The overall response
rate observed in this study of advanced-stage patients with high
FGFR2b-overexpressing GEA was 17.9% (95% CI 6.1% to 36.9%) with
five of 28 patients achieving a confirmed partial response.
“Gastroesophageal adenocarcinoma is the third most common cause
of cancer death worldwide and the median overall survival of
patients who present with advanced disease remains dismal at only
11 months,” said Helen Collins, M.D., Executive Vice President and
Chief Medical Officer of Five Prime Therapeutics. “The results of
this study underscore the potential of bemarituzumab evaluation as
a novel treatment option for patients with advanced gastric and
gastroesophageal junction cancer.”
“Monotherapy activity of bemarituzumab and its lack of
significant overlapping toxicities with standard chemotherapeutic
agents suggest that combining bemarituzumab with chemotherapy may
potentially benefit patients in the front-line setting whose GEA
tumors overexpress FGFR2b,” said Daniel Catenacci, M.D. and
Associate Professor, the University of Chicago Medical Center and
Biological Sciences.
Bemarituzumab is being evaluated in combination with mFOLFOX6 in
the Phase 3 FIGHT (FGFR2b
Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial in the front-line treatment
setting.
About Five Prime Therapeutics
Five Prime Therapeutics, Inc. discovers and develops innovative
protein therapeutics to improve the lives of patients with serious
diseases. Five Prime’s product candidates have innovative
mechanisms of action and address patient populations in need of
better therapies. The company focuses on researching and developing
immuno-oncology and targeted cancer therapies paired with companion
diagnostics to identify patients who are most likely to benefit
from treatment with Five Prime’s product candidates. 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 or follow us on LinkedIn, Twitter and
Facebook.
About Bemarituzumab and the FIGHT Trial
Bemarituzumab (anti-FGFR2b) is a first-in-class
isoform-selective antibody with enhanced antibody-dependent
cell-mediated cytotoxicity (ADCC) in development as a targeted
immunotherapy for tumors that overexpress FGFR2b. Bemarituzumab is
being evaluated in combination with mFOLFOX6 in the Phase 3
FIGHT (FGFR2b
Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial.
In December 2017, Five Prime initiated the Phase 1 portion
(NCT03343301) of the Phase 1/3 FIGHT (FGFR2b Inhibition in Gastric
and Gastroesophageal Junction Cancer Treatment) global
registrational trial. The Phase 1 safety lead-in portion of the
trial was designed to identify a recommended dose of bemarituzumab
in combination with the modified FOLFOX6 standard-of-care
chemotherapy regimen (mFOLFOX6) to support the initiation of the
Phase 3 portion of the trial.
The Phase 3 portion of the FIGHT trial is evaluating
bemarituzumab in combination with mFOLFOX6 versus placebo plus
mFOLFOX6 in approximately 550 patients with gastric cancer or
gastroesophageal junction cancer whose tumors overexpress FGFR2b.
The Phase 3 portion of the trial began in September 2018 and the
primary endpoint of the FIGHT trial is overall survival (OS) with
secondary endpoints of progression-free survival (PFS), objective
response rate (ORR), safety and pharmacokinetic (PK)
parameters.
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. 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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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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