Summit Therapeutics (SMMT) said Friday its partner Akeso has received approval from China's National Medical Products Administration for a second use of ivonescimab.
The approval was based on results from a phase 3 clinical trial, called HARMONi-2, which tested ivonescimab alone against pembrolizumab alone in patients with advanced non-small cell lung cancer that shows PD-L1 protein, the company said.
Following NMPA's instructions, Akeso conducted an interim analysis of overall survival and reported a hazard ratio of 0.777, based on 39% of the total data collected so far, it added.
Summit is also running the HARMONi-7 trial, a global phase 3 study evaluating ivonescimab against pembrolizumab in a similar group of NSCLC patients for regulatory approval in the United States and other licensed regions, according to the company.
Shares of the company were down nearly 32% in recent trading.
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