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Key clinical point: Bemarituzumab is safe and may lead to clinically meaningful improvements in progression-free survival (PFS) in patients with fibroblast growth factor receptor 2b (FGFR2b)-selected advanced gastric or gastro-esophageal junction adenocarcinoma compared with placebo.
Major finding: After a 10.9-month median follow-up, the bemarituzumab and placebo groups had a median PFS of 9.5 (95% CI 7.3-12.9) and 7.4 (95% CI 5.8-8.4) months, respectively (hazard ratio 0.68; P = .073), and serious treatment-emergent adverse event rates of 32% and 36%, respectively.
Study details: Findings are from a multicenter phase 2 study, FIGHT, that included 155 adult patients with HER2 non-positive, FGFR2b-selected advanced gastric (n = 137) or gastro-esophageal junction (n = 18) adenocarcinoma who were randomized (1:1) to bemarituzumab (n = 77) or placebo (n = 78) plus modified 5-fluorouracil, leucovorin, and oxaliplatin.
Disclosures: Five Prime Therapeutics funded this study. Some authors declared receiving consulting, advisory, speaking fees, research funding, honoraria, or travel, accommodation and expenses from various sources, including Five Prime. Three authors reported employment and stock or other ownership interests in Five Prime.
Source: Wainberg ZA et al. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): A randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2022;23(11):1430-1440 (Oct 13). Doi: 10.1016/S1470-2045(22)00603-9
Key clinical point: Bemarituzumab is safe and may lead to clinically meaningful improvements in progression-free survival (PFS) in patients with fibroblast growth factor receptor 2b (FGFR2b)-selected advanced gastric or gastro-esophageal junction adenocarcinoma compared with placebo.
Major finding: After a 10.9-month median follow-up, the bemarituzumab and placebo groups had a median PFS of 9.5 (95% CI 7.3-12.9) and 7.4 (95% CI 5.8-8.4) months, respectively (hazard ratio 0.68; P = .073), and serious treatment-emergent adverse event rates of 32% and 36%, respectively.
Study details: Findings are from a multicenter phase 2 study, FIGHT, that included 155 adult patients with HER2 non-positive, FGFR2b-selected advanced gastric (n = 137) or gastro-esophageal junction (n = 18) adenocarcinoma who were randomized (1:1) to bemarituzumab (n = 77) or placebo (n = 78) plus modified 5-fluorouracil, leucovorin, and oxaliplatin.
Disclosures: Five Prime Therapeutics funded this study. Some authors declared receiving consulting, advisory, speaking fees, research funding, honoraria, or travel, accommodation and expenses from various sources, including Five Prime. Three authors reported employment and stock or other ownership interests in Five Prime.
Source: Wainberg ZA et al. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): A randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2022;23(11):1430-1440 (Oct 13). Doi: 10.1016/S1470-2045(22)00603-9
Key clinical point: Bemarituzumab is safe and may lead to clinically meaningful improvements in progression-free survival (PFS) in patients with fibroblast growth factor receptor 2b (FGFR2b)-selected advanced gastric or gastro-esophageal junction adenocarcinoma compared with placebo.
Major finding: After a 10.9-month median follow-up, the bemarituzumab and placebo groups had a median PFS of 9.5 (95% CI 7.3-12.9) and 7.4 (95% CI 5.8-8.4) months, respectively (hazard ratio 0.68; P = .073), and serious treatment-emergent adverse event rates of 32% and 36%, respectively.
Study details: Findings are from a multicenter phase 2 study, FIGHT, that included 155 adult patients with HER2 non-positive, FGFR2b-selected advanced gastric (n = 137) or gastro-esophageal junction (n = 18) adenocarcinoma who were randomized (1:1) to bemarituzumab (n = 77) or placebo (n = 78) plus modified 5-fluorouracil, leucovorin, and oxaliplatin.
Disclosures: Five Prime Therapeutics funded this study. Some authors declared receiving consulting, advisory, speaking fees, research funding, honoraria, or travel, accommodation and expenses from various sources, including Five Prime. Three authors reported employment and stock or other ownership interests in Five Prime.
Source: Wainberg ZA et al. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): A randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2022;23(11):1430-1440 (Oct 13). Doi: 10.1016/S1470-2045(22)00603-9