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ESMO 2025 | FORTITUDE-101: bemarituzumab & chemo in FGFR2b-overexpressing G/GEJC
Kohei Shitara, MD, National Cancer Center Hospital East, Kashiwa, Japan, comments on the Phase III FORTITUDE-101 study (NCT05052801) of bemarituzumab plus chemotherapy in patients with FGFR2b-positive gastric or gastroesophageal junction cancer (G/GEJC). The study met its primary endpoint of overall survival at interim analysis, and the final follow-up results showed attenuation of the survival difference. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
In this ESMO, we have some exciting or important presentations. First is bemarituzumab plus chemotherapy, FORTITUDE-101, especially for FGFR2b-positive population. FGFR2b-positive was defined by 10% threshold, and there is some overlap with FGFR2 amplification. So this is a clearly first study to test this monoclonal antibody for gastric cancer. And that study meets a primary endpoint, overall survival at the interim analysis...
In this ESMO, we have some exciting or important presentations. First is bemarituzumab plus chemotherapy, FORTITUDE-101, especially for FGFR2b-positive population. FGFR2b-positive was defined by 10% threshold, and there is some overlap with FGFR2 amplification. So this is a clearly first study to test this monoclonal antibody for gastric cancer. And that study meets a primary endpoint, overall survival at the interim analysis. As already presented, it showed median survival more than five months difference with a hazard ratio around 0.61. However, additional several months follow-up somehow changed the result with attenuation of difference of overall survival with median less than two months difference and the hazard ratio 0.82. So it is very hard to conclude this study, but maybe we need to consider this final follow-up overall survival as most important result. So in that case, to receive regulatory approval might be not easy, but it suggests at least some range of activity in this unmet needed population. And currently, very importantly, another FGFR2b trial is ongoing as a Fortitude 102, which combines chemotherapy, checkpoint inhibitor, and nivolumab. And safety profile is in line with the previous report. Bemarituzumab-induced eye toxicity of keratitis. But it is in line with the previous report so anyway it is not easy to interpret and not easy to conclude but let’s stay tuned for the 102 study which will be reported in the near future.
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