# FORTITUDE-101

Source: https://onco.cc/trials/fortitude-101/  
OnCo record `fortitude-101` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-07
- Registry id: NCT05052801
- Phase: 3
- Setting: First-line FGFR2b-overexpressing (≥10% 2+/3+), HER2-negative advanced gastric/GEJ cancer: bemarituzumab + mFOLFOX6 vs placebo + mFOLFOX6
- Sponsor: Amgen
- Enrolled: 547
- Result: Interim OS 17.9 vs 12.5 months (HR 0.61); benefit attenuated on follow-up.
- Outcomes: Overall survival (interim): Bemarituzumab + mFOLFOX6 17.9 months vs Placebo + mFOLFOX6 12.5 months, HR 0.61
- Replication: Phase 2 FIGHT showed a similar early signal; no confirmatory trial yet.

## Sources

- ClinicalTrials.gov NCT05052801: https://clinicaltrials.gov/study/NCT05052801
- ESMO 2025 LBA10: https://www.annalsofoncology.org/article/S0923-7534(25)04862-8/fulltext

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [FGFR2](https://onco.cc/targets/fgfr2/)
- drugs: [Bemarituzumab](https://onco.cc/drugs/bemarituzumab/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/)
- companies: [Amgen](https://onco.cc/companies/amgen/)
- people: [Zev A. Wainberg](https://onco.cc/people/zev-wainberg/)

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