Shots:
- The US FDA has approved Tevimbra + Pt & fluoropyrimidine-based CT as a 1L treatment of inoperable or metastatic HER2- G/GEJ adenocarcinoma with PD-L1 (≥1) expression. Another BLA for 1L locally advanced unresectable or metastatic ESCC is under review
- Approval was based on P-III (RATIONALE-305) study of Tevimbra + CT vs PBO in patients (n=997) that achieved 1EP, showing OS benefits with a 20% reduction in the death risk & mOS of 15 vs 12.9mos.
- Pooled safety analysis included data from 2 studies (RATIONALE-302 & BGB-A317-303) in 1,972 patients plus 5 trials (BGB-A317-208, BGB-A317-204, BGB-A317-203, BGB-A317-102 & BGB A317_Study_001) in patients with ESCC (n=307) & advanced or recurrent tumors (n=1,665)
Ref: BeiGene | Image: BeiGene| Press Release
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