FORTITUDE-101
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.
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.
Setting
First-line FGFR2b-overexpressing (≥10% 2+/3+), HER2-negative advanced gastric/GEJ cancer: bemarituzumab + mFOLFOX6 vs placebo + mFOLFOX6
Phase
Phase 3
Sponsor
Amgen
Registry
Headline result
Interim OS 17.9 vs 12.5 months (HR 0.61); benefit attenuated on follow-up.
Reported
2025
Enrolled
547
Replication
Phase 2 FIGHT showed a similar early signal; no confirmatory trial yet.
In plain words
What these results mean for people, not percentages
Overall survival (interim)primarysurvival endpoint
- Median 17.9 vs 12.5 months with Bemarituzumab + mFOLFOX6 compared with Placebo + mFOLFOX6; about 5.4 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 39 percent lower chance of the event at any given time (hazard ratio 0.61).
- The p-value (0.005) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: First-line FGFR2b-overexpressing (≥10% 2+/3+), HER2-negative advanced gastric/GEJ cancer: bemarituzumab + mFOLFOX6 vs placebo + mFOLFOX6. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
547 participants enrolled.
Overall survival (interim)primary
HR 0.61 · p = 0.005
Bemarituzumab + mFOLFOX6
17.9 mo
Placebo + mFOLFOX6
12.5 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (interim)primary | Bemarituzumab + mFOLFOX6 | — | 17.9 months | 0.61 | 0.005 | link |
| Placebo + mFOLFOX6 | — | 12.5 months |
Replication
Phase 2 FIGHT showed a similar early signal; no confirmatory trial yet.