Five Prime Therapeutics Completes Phase 1 Safety Lead-In and Initiates Phase 3, Global Registrational Trial of Bemarituzumab in Front-Line Advanced Gastric and Gastroesophageal Junction Cancers
- Five Prime plans to submit Phase 1 lead-in data for presentation at medical conference in the first half of 2019
“We are very pleased to have completed the safety lead-in and move into
the Phase 3 registrational portion of the bemarituzumab trial in
patients with gastric cancer,” said
The randomized, controlled, double-blinded Phase 3 portion of the FIGHT
trial will evaluate bemarituzumab plus mFOLFOX6 versus placebo plus
mFOLFOX6 in approximately 550 patients with gastric cancer (GC) or
gastroesophageal junction (GEJ) cancer whose tumors overexpress FGFR2b.
The Phase 3 trial will include approximately 250 sites in the U.S.,
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.
Unmet Need in GC and GEJ
GC, including GEJ cancer, is the fifth most common cancer worldwide and third leading cause of cancer death.
Current first-line chemotherapy treatment delays progression by approximately 6 months compared to best supportive care, but median OS remains poor with literature-reported ranges of approximately 10 to 11 months and PFS of approximately 6 months. The presence of FGFR2b overexpression is present in approximately 10% of patients with GC/GEJ and is associated with a worse prognosis. Few treatment options following progression are available after first-line chemotherapy and a significant unmet need remains in the treatment of GC/GEJ.
Five Prime is developing companion diagnostics to identify FGFR2b overexpression using an IHC test and FGFR2 gene amplification using ctDNA analysis. Five Prime will use both assays to select patients for the FIGHT trial.
Bemarituzumab is a first-in-class, isoform-selective, humanized monoclonal antibody in clinical development as a targeted immunotherapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. Bemarituzumab blocks FGFs 7, 10 and 22 from binding to FGFR2b, and has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Clinical results to date suggest that the specificity of bemarituzumab avoids the dose-limiting toxicities that have been seen with less selective pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs, including FGFR2.
About Five Prime
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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. Forward-looking statements contained in this
press release include statements about (i) the timing of initiation,
progress and scope of clinical trials for Five Prime's bemarituzumab
product candidate; (ii) the potential use of bemarituzumab to treat
cancer patients; (iii) the extent of FGFR2b overexpression in gastric
cancer patients; and (iv) the advancement of bemarituzumab into Phase 3
clinical development. Many factors may cause differences between current
expectations and actual results, including unexpected safety or efficacy
data observed during non-clinical or clinical studies, clinical site
activation rates or clinical trial enrollment rates that are lower than
expected and changes in expected or existing competition. 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
Five Prime Therapeutics, Inc.
Heather Rowe, 415-365-5737
Senior Director, Investor Relations and Corporate Communications