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- Phase 3 trial evaluating bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6
"We are very pleased to have dosed the first patient in our FIGHT gastric cancer trial in
"This is the first time that the first patient dosed in a global registrational trial came from
About the FIGHT Trial
The double-blind randomized and controlled Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment)trial will evaluate 15 mg/kg of bemarituzumab or placebo given every two weeks combined with modified FOLFOX6 (mFOLFOX6) chemotherapy in approximately 550 patients with GC or GEJ cancer whose tumors overexpress FGFR2b. The Phase 3 global registration trial is the first prospective FGFR2b-specific front-line gastric study and will include approximately 250 sites in the U.S.,
The primary endpoint of the FIGHT trial is overall survival (OS), with key secondary endpoints being 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. Gastric cancer is the second most common cancer in
Current first-line chemotherapy treatment delays progression by approximately six 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 six 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 worldwide.
Five Prime is developing companion diagnostics to identify FGFR2b overexpression using an immunohistochemistry (IHC) test and FGFR2 gene amplification using circulating tumor DNA (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
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. Forward-looking statements contained in this press release include statements about (i) the timing of initiation, progress and scope of the Phase 3 FIGHT trial for Five Prime's bemarituzumab product candidate; (ii) the potential use of bemarituzumab to treat cancer patients; (iii) the extent of FGFR2b overexpression and FGFR2 gene amplification in gastric cancer patients; and (iv) the advancement of bemarituzumab in 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
Heather Rowe, 415-365-5737
Senior Director, Investor Relations and Corporate Communications
ZAI LAB CONTACTS:
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Burns McClellan, on behalf of Zai Lab
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Robert E. Flamm, 212-213-0006, ext. 364
Jill Steier, 212-213-0006, ext. 367