Summit Therapeutics Inc. ( SMMT ) on Friday noted that Akeso, Inc. announced the Chinese Health Authorities, the National Medical Products Administration (NMPA) approved ivonescimab for a second indication based on the results of the Phase 3 trial, HARMONi-2 or AK112-303.

On Friday, Summit Therapeutics ( SMMT ) stock closed almost 30% lower at around $23.47.

HARMONi-2 evaluated monotherapy ivonescimab, PD-1/VEGF bispecific antibody, against monotherapy Merck ( MRK ) & Co Inc’s Keytruda (pembrolizumab) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression. HARMONi-2 was conducted in China, sponsored by Akeso, with all relevant data exclusively generated, managed and analyzed by Akeso.

As part of the review of Akeso’s supplemental marketing application seeking a label expansion of ivonescimab in China, the NMPA requested that Akeso perform an interim analysis of overall survival (OS).

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Akeso announced the results of this interim overall survival analysis included a clinically meaningful hazard ratio of 0.777.

The analysis was conducted at 39% data maturity, with a nominal alpha level of 0.0001.

In September 2024, for the primary analysis for HARMONi-2, ivonescimab monotherapy demonstrated a statistically significant improvement in the trial’s primary endpoint, progression-free survival (PFS) by Independent Radiologic Review Committee, when compared to monotherapy pembrolizumab, achieving a hazard ratio (HR) of 0.51 (p