Shots:
- The US FDA has approved the sBLA for Tevimbra (tislelizumab) + Ziihera (zanidatamab) & CT for the 1L treatment of adults with unresectable locally advanced or metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA)
- Approval was based on the P-III (HERIZON-GEA-01) assessing the efficacy & safety of Ziihera+ CT, with and without Tevimbra, to the SoC (Herceptin + CT) in 914 adults with advanced/metastatic HER2+ GEA
- In HERIZON-GEA-01, Tevimbra + Ziihera + CT improved mOS to 26.4 vs 19.2mos. & PFS to 12.4 vs 8.1mos., with benefits across PD-L1 status & HER2 IHC 3+/2+ subgroups, where pts with PD-L1-negative tumors (TAP <1%) showed mOS of 29.7 vs 15.8mos.; data published in The NEJM
Ref: Businesswire | Image: BeOne Medicines | Press Release
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