Shots:
- Akeso and Summit has reported the P-III (HARMONi-2/AK112-303) trial data assessing ivonescimab monotx. vs Keytruda in Chinese pts with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression
- Trial showed improvement in OS (2EP), with results to be presented in future. In the primary analysis, trial met it 1EP of improved PFS, with clinical benefit observed across clinical subgroups, incl. pts with PD-L1 low or high expression, squamous, & non-squamous histologies
- 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: Summit & Akeso | Press Release
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