Amgen's bemarituzumab showed a reduced survival benefit in gastric cancer at the final analysis of the Phase 3 FORTITUDE-101 trial compared to the stronger results seen at the interim analysis15.
The interim analysis had previously demonstrated a statistically significant and clinically meaningful improvement in overall survival for patients with FGFR2b-positive, HER2-negative unresectable, locally advanced, or metastatic gastric or gastroesophageal junction cancer234.
At the final analysis, the magnitude of survival benefit observed earlier was weakened, prompting Zai Lab to defer regulatory filings until data from the FORTITUDE-102 trial is available15.
FORTITUDE-102 investigates bemarituzumab plus chemotherapy in combination with Bristol Myers Squibb's Opdivo (nivolumab) and is expected to read out by late 2025 or early 202615.
Analysts note disappointment in the deteriorating survival benefit and highlight the importance of future results, given safety issues and changing standards of care5.
Sources:
1. https://www.fiercebiotech.com/biotech/amgens-stomach-cancer-candidate-takes-turn-attenuated-os-benefits-final-phase-3-analysis
2. https://www.appliedclinicaltrialsonline.com/view/amgen-bemarituzumab-chemotherapy-combination-significantly-improves-overall-survival-unresectable-locally-advanced-metastatic-gej-cancer
3. https://www.amgen.com/newsroom/press-releases/2025/06/amgen-announces-positive-topline-phase-3-results-for-bemarituzumab-in-fibroblast-growth-factor-receptor-2b-fgfr2b-positive-firstline-gastric-cancer
4. https://www.biospace.com/press-releases/amgen-announces-positive-topline-phase-3-results-for-bemarituzumab-in-fibroblast-growth-factor-receptor-2b-fgfr2b-positive-first-line-gastric-cancer
5. https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/09/47506926/amgen-faces-setback-as-final-data-weakens-case-for-gastric-cancer-drug