Summit Therapeutics Inc. noted on April 25, 2025, that its partner, Akeso, Inc., received approval from the Chinese National Medical Products Administration (NMPA) for ivonescimab for a second indication. This approval is for monotherapy in the first-line treatment of advanced NSCLC in tumors with positive PD-L1 expression, based on results from the Phase III HARMONi-2 trial.
An interim analysis of overall survival (OS) for HARMONi-2, requested by the NMPA, showed a clinically meaningful hazard ratio of 0.777 at 39% data maturity. This implies a potential 22% reduction in the risk of death compared to pembrolizumab monotherapy.
The HARMONi-2 trial previously demonstrated a statistically significant improvement in progression-free survival (PFS) with a hazard ratio of 0.51 (p<0.0001) in September 2024. This new approval and positive OS trend further support ivonescimab's potential as a differentiated immunotherapy.
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