Summit Therapeutics announces availability of ivonescimab HARMONi trial update press release
SMMT•Regulatory timeline
FDA review of the ivonescimab BLA targets a PDUFA action date of Nov. 14, 2026.
HARMONi overall survival update
Summit Therapeutics posted an updated overall survival analysis from the Phase III HARMONi study of ivonescimab with platinum-doublet chemotherapy.
- June 2026 data cut showed an OS hazard ratio of 0.76 in the intention-to-treat population.
- The April 2025 primary OS analysis showed an HR of 0.79.
