Summit Therapeutics announced updated, positive overall survival (OS) results from its global Phase III HARMONi clinical trial for ivonescimab in patients with EGFR-mutated non-small cell lung cancer (NSCLC). The data, presented at the WCLC 2026 conference, showed a consistent survival improvement with longer follow-up, particularly in Western patients, and supports the company's Biologics License Application (BLA) currently under FDA review.
Key Details
- HARMONi Trial Results: An updated analysis (June 2026 data cut-off) demonstrated a favorable OS hazard ratio of 0.76 for ivonescimab plus chemotherapy compared to placebo plus chemotherapy.
- Western Patient Data: With a median follow-up of 23.2 months, the Western patient subgroup showed a consistent survival improvement (HR of 0.76), reinforcing the drug's efficacy across geographic regions.
- Regulatory Status: The BLA for ivonescimab, based on the HARMONi trial, is under review by the U.S. FDA with a PDUFA target action date of November 14, 2026.
- HARMONi-2 Trial Data: Results from a separate, partner-sponsored trial (HARMONi-2) in China showed ivonescimab monotherapy achieved a statistically significant OS improvement over pembrolizumab (HR of 0.73).