Summit Therapeutics announced results from an updated overall survival (OS) analysis of its Phase III HARMONi clinical trial for ivonescimab. The trial is evaluating the drug for patients with a specific type of non-small cell lung cancer (NSCLC). The new data, with longer patient follow-up, showed a continued positive trend in overall survival.
Key Details
- Trial Update: The latest analysis, with a data cutoff of June 2026, demonstrated a hazard ratio (HR) of 0.76 for the full patient population, an improvement from the 0.79 HR in the primary analysis.
- Patient Population: The HARMONi study evaluates ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated.
- Regulatory Status: These updated results have been submitted to the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for ivonescimab has a PDUFA goal action date of November 14, 2026.