other material
confidence high
sentiment positive
materiality 0.80
Summit reports updated OS HR 0.76 for ivonescimab in HARMONi; consistent in western and Asian patients
Summit Therapeutics Inc.
- Updated OS analysis from Phase III HARMONi shows HR 0.76 for full ITT population and western subgroup.
- Western patients median follow-up now 23.2 months; Asian patients locked at 32.7 months.
- Ivonescimab plus chemo continues to show acceptable safety profile; no new safety signals.
- BLA for ivonescimab in EGFR-mutated NSCLC under FDA review; PDUFA date November 14, 2026.
- Results made available to FDA; detailed data planned for presentation at upcoming medical conference.