Bemarituzumab Plus Chemotherapy Significantly Improves Survival in FGFR2b+ Gastric Cancer

In a significant advancement for the treatment of advanced gastric cancer, the combination of bemarituzumab and chemotherapy has been shown to improve overall survival (OS) in patients with fibroblast growth factor receptor 2b (FGFR2b) overexpression. Results from the phase 3 FORTITUDE-101 trial were announced on June 30, 2025, by Amgen, demonstrating that patients receiving bemarituzumab alongside the modified FOLFOX6 regimen experienced a statistically significant improvement in survival compared to those receiving a placebo with chemotherapy.

The FORTITUDE-101 trial, which enrolled 547 participants from 300 sites across 37 countries, specifically targeted individuals with FGFR2b overexpression—defined as 2+ or 3+ staining on at least 10% of tumor cells. This biomarker-driven approach is crucial, as the majority of gastric cancer cases are diagnosed at an advanced stage, often leading to poor prognoses and limited treatment options. According to Dr. Jay Bradner, Executive Vice President of Research and Development at Amgen, “These first positive topline results of an FGFR2b-targeted monoclonal antibody mark a meaningful advance in the development of effective targeted therapy for gastric cancer.”

The results indicated that the most commonly reported adverse effects (AEs) in the bemarituzumab treatment group included ocular issues such as reduced visual acuity and punctate keratitis, alongside hematological toxicities like anemia and neutropenia. Notably, these AEs occurred at a higher frequency and severity compared to the placebo group, aligning with findings from earlier phase 2 trials.

The primary endpoint of the trial, overall survival, was met, and secondary endpoints included progression-free survival and objective response rate. The data from this interim analysis are set to be presented at an upcoming medical conference, which could provide additional insights into the safety and efficacy of the treatment combination.

In comparison to traditional treatment options, the introduction of bemarituzumab represents a shift towards more personalized medicine in oncology. The FORTITUDE-102 trial, which is currently ongoing, is investigating the efficacy of bemarituzumab combined with chemotherapy and nivolumab, with results expected in late 2025. This trial aims to further refine treatment strategies for patients with previously untreated gastric cancer while maintaining a focus on biomarker-driven therapy.

Overall, the progress made with bemarituzumab highlights the potential for targeted therapies in improving outcomes for patients suffering from advanced gastric cancer. As research continues and results are confirmed through further clinical trials, the hope for more effective and personalized treatment options grows, potentially changing the landscape of care for this challenging disease.