Akeso and Summit Report P-III (HARMONi-GI1) Trial Data on Ivonescimab + CT for 1L Advanced Biliary Tract Cancer
Shots:
- Akeso and Summit have reported interim analysis from the P-III (AK112-309/HARMONi-GI1) trial assessing ivonescimab + CT vs durvalumab + CT for the 1L treatment of advanced biliary tract cancer (BTC)
- Trial met its 1EP of OS, plus achieved all key 2EPs of PFS & ORR; data will be presented at the academic conference & published in a peer-reviewed journal
- In 2026, Summit initiated P-II/III (HARMONi-GU1) study in urothelial carcinoma, with global site activations planned from Q4’26. Ivonescimab’s BLA is under FDA review for EGFR-mutated, LA/M nsq-NSCLC previously treated with a third-generation EGFR TKI (PDUFA: Nov 14, 2026)
Ref: Businesswire | Image: Akeso & Summit | Press Release
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