- Amgen’s P-III (FORTITUDE-101) study (n=547) met its 1EP at interim analysis, showing statistically significant OS improvement with bemarituzumab + CT (mFOLFOX6) vs PBO + CT in FGFR2b+ unresectable locally advanced/metastatic G/GEJ cancer (FGFR2b ≥10% IHC 2+/3+)
- P-III (FORTITUDE-101) study 2EPs include PFS and ORR; the safety profile of bemarituzumab + CT was consistent with prior data
- This study was supported by Zai Lab, which holds co-development and commercialization rights for bemarituzumab in mainland China, Hong Kong, Macau, and Taiwan. Furthermore, the company is currently conducting a separate P-III study of bemarituzumab + CT + nivolumab in 1L gastric cancer, with readout expected in H2’25
Ref: Prnewswire | Image: Amgen | Press Release
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