{"entity":{"id":"fortitude-101","kind":"trial","name":"FORTITUDE-101","aka":[],"tldr":"A new target, FGFR2b, showed a survival gain at first look that shrank with longer follow-up, and the trial did not include the immunotherapy patients now routinely get.","summary":"Interim analysis: OS 17.9 vs 12.5 months (HR 0.61, p=0.005). Updated analysis (ESMO 2025) showed the difference attenuate and lose significance. The chemotherapy-only control (no PD-1) and ocular toxicity (corneal events in most patients) limit interpretation. FORTITUDE-102 tests the combination with nivolumab.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05052801","url":"https://clinicaltrials.gov/study/NCT05052801"},{"label":"ESMO 2025 LBA10","url":"https://www.annalsofoncology.org/article/S0923-7534(25)04862-8/fulltext"}],"tags":[],"related":[],"cancers":["gastric"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["fgfr2"],"drugs":["bemarituzumab","folfox"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["zev-wainberg"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05052801","phase":"3","setting":"First-line FGFR2b-overexpressing (≥10% 2+/3+), HER2-negative advanced gastric/GEJ cancer: bemarituzumab + mFOLFOX6 vs placebo + mFOLFOX6","sponsor":"Amgen","result":"Interim OS 17.9 vs 12.5 months (HR 0.61); benefit attenuated on follow-up.","started":"2022-03-07","startedType":"actual","yearReported":2025,"enrolled":547,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (interim)","primary":true,"unit":"months","arms":[{"name":"Bemarituzumab + mFOLFOX6","value":17.9},{"name":"Placebo + mFOLFOX6","value":12.5}],"hr":0.61,"p":"0.005","source":"https://www.annalsofoncology.org/article/S0923-7534(25)04862-8/fulltext"}],"replication":"Phase 2 FIGHT showed a similar early signal; no confirmatory trial yet."},"route":"/trials/fortitude-101/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"fgfr2","kind":"target","name":"FGFR2","route":"/targets/fgfr2/"}],"drug":[{"id":"bemarituzumab","kind":"drug","name":"Bemarituzumab","route":"/drugs/bemarituzumab/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"}],"person":[{"id":"zev-wainberg","kind":"person","name":"Zev A. Wainberg","route":"/people/zev-wainberg/"}]}}