Summit Therapeutics Says Extended Follow-Up Reveals Stronger Survival Advantages with Lead Cancer Drug
Summit Therapeutics announced updated overall survival data from its Phase 3 HARMONi study evaluating ivonescimab, an investigational bispecific antibody, combined with chemotherapy for EGFR-mutated non-small cell lung cancer. The latest analysis, with a 23.2-month median follow-up for Western patients, showed a hazard ratio of 0.76, improving from 0.78 in September 2025. The primary analysis in April 2025 showed median overall survival of 16.8 months for the ivonescimab group versus 14.0 months for placebo, though it did not reach statistical significance. The safety profile remained manageable with no new adverse signals. Summit has submitted these findings to the FDA to support its Biologics License Application, with a target action date of November 14, 2026.
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