The randomized phase II clinical FIGHT study observed an improved, but non-significant, progression-free survival (PFS) with bemarituzumab plus chemotherapy in untreated patients with advanced gastric or gastroesophageal junction cancer. The study describing these results was recently published in the journal The Lancet Oncology.
The fibroblast growth factor receptor 2b (FGFR2b) is overexpressed in gastric cancer patients. The FIGHT trial has investigated the safety and efficacy of the anti-FGFR2b monoclonal antibody bemarituzumab combined with chemotherapy (modified 5-fluorouracil, leucovorin, and oxaliplatin, i.e. mFOLFOX6).
The randomized, phase-II, placebo-controlled FIGHT study enrolled 155 patients (18 years or older, HER2 non-positive, FGFR2b expression or FGFR2 amplification) with untreated locally advanced or metastatic gastric cancer. All of the patients were treated with mFOLFOX6 and randomly assigned (1:1) to receive either bemarituzumab (n=77) or placebo (n=78). The study’s primary endpoint was the PFS. Additionally, all of the participants who received at least one treatment dose were assessed for safety.
After a median follow-up of 10.9 months, the median PFS was increased to 9.5 months (95% CI 7·3–12·9) for bemarituzumab in comparison to placebo (7.4 months, 95% CI 0·44–1·04). However, these differences were statistically insignificant (p=0·073). The most common grade 3 or 4 adverse events in the bemarituzumab group were cornea disorder (24% for bemarituzumab vs none for placebo), neutrophil count (30% vs 35%), neutropenia (13% vs 9%), stomatitis (9% vs 1%), and anaemia (8% vs 13%). Serious treatment-emergent adverse events were seen in both the bemarituzumab (32%) and placebo group (36%). Notably, three patients died due to treatment in the bemarituzumab group vs none in the placebo arm.
Despite not reaching statistical significance, the use of bemarituzumab for gastric cancer patients shows promise. Phase-III trials are currently ongoing and are enrolling larger patient populations, which gives these trials the potential to demonstrate the clinical significance of bemarituzumab.
Wainberg ZA, Enzinger PC, Kang YK, 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;22:S1470-2045.