Summit Therapeutics Inc. announced on September 7, 2025, updated overall survival (OS) results from its global Phase III HARMONi clinical trial, presented at the Presidential Symposium of the 2025 World Conference on Lung Cancer (WCLC). The updated data showed a statistically significant OS benefit for ivonescimab plus chemotherapy.
The OS Hazard Ratio (HR) was 0.78, with a nominal p-value of 0.0332, favoring ivonescimab compared to placebo plus chemotherapy in patients with EGFR-mutated NSCLC who progressed after a third-generation EGFR TKI. This update addresses the previous primary analysis which showed a positive trend but did not achieve statistical significance for OS.
Longer-term follow-up of Western patients demonstrated an improving, favorable trend in overall survival. This enhanced OS data, combined with the previously reported statistically significant progression-free survival benefit, strengthens the clinical profile of ivonescimab for potential regulatory submissions in global markets.
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