Summit Therapeutics Inc. announced on May 30, 2025, topline results from its global Phase III HARMONi clinical trial, which evaluated ivonescimab plus platinum-doublet chemotherapy in patients with EGFR-mutated NSCLC who progressed after a third-generation EGFR TKI. The study successfully met its primary endpoint of progression-free survival (PFS).
Ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS, with a hazard ratio of 0.52 (95% CI: 0.41 – 0.66; p<0.00001). This PFS benefit was consistent across both Asian and ex-Asian patient populations.
However, the trial showed only a positive trend in overall survival (OS) in the primary analysis, with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057), without achieving statistical significance. Summit intends to file a Biologics License Application (BLA), but the FDA has indicated that a statistically significant overall survival benefit is necessary to support marketing authorization, which will influence the timing of the BLA filing.
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