Clinical TrialJul 22, 2026, 07:16 AM
Summit's Ivonescimab Phase III OS Analysis Shows HR 0.76
AI Summary
Summit Therapeutics announced updated overall survival (OS) analysis results from its global Phase III HARMONi clinical trial for ivonescimab in EGFR-mutated non-small cell lung cancer. The analysis, with a June 2026 data cutoff, showed a consistent OS trend with a hazard ratio of 0.76 for the full population and western patient subgroups. The drug maintained an acceptable and manageable safety profile, and these results have been provided to the FDA, which has a PDUFA goal action date of November 14, 2026, for the Biologics License Application.
Key Highlights
- Updated overall survival (OS) analysis from Phase III HARMONi trial for ivonescimab.
- Hazard ratio of 0.76 observed for the full intention-to-treat population.
- Hazard ratio of 0.76 also observed in western patient subgroups.
- Median follow-up for western patients reached 23.2 months.
- Ivonescimab demonstrated an acceptable and manageable safety profile with no new signals.
- Results made available to the FDA; BLA PDUFA goal action date is November 14, 2026.
- Primary analysis (April 2025) showed HR 0.79 (p=0.057) with median OS of 16.8 months vs 14.0 months.
- September 2025 analysis showed HR 0.78 (nominal p=0.0332) for western patients with 13.7 months follow-up.
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