Shots:
- FDA has granted priority review to BeOne‘s Tevimbra + Ziihera & CT for the 1L treatment of unresectable locally advanced/metastatic HER2+ gastric, GEJ, or esophageal adenocarcinoma; BeOne plans to participate in the FDA’s Project Orbis
- sBLA was based on the P-III (HERIZON-GEA-01) trial, which assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as the 1L treatment in 914 adults with HER2+ locally advanced or metastatic GEA
- Ziihera + CT and Ziihera + Tevimbra + CT showed prolonged PFS with mOS of 24.4 & 26.4mos., respectively vs 19.2mos., while mPFS was 12.4mos. for both combinations vs 8.1mos.; benefit was observed regardless of PD-L1 status
Ref: Businesswire | Image: BeOne | Press Release
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