STAT+: Akeso wins Chinese approval for cancer drug positioned to rival Merck’s Keytruda

Akeso, a Chinese biotech that made headlines for beating Merck’s Keytruda in a head-to-head trial, won approval in China this week for the therapy, a company spokesperson confirmed to STAT. New data show early hints of the medicine improving patient survival — the gold standard outcome of any cancer study.

The drug, ivonescimab, was approved for previously untreated patients with non-small cell lung cancer who had detectable levels of PD-L1, a protein that tamps down immune responses. China’s National Medical Products Administration greenlit the therapy based on results from a late-stage trial, HARMONi-2, which found Akeso’s therapy reduced patients’ risk of tumor progression by 49% compared with Keytruda.

In its submission to regulators, Akeso also included data on patient survival. In an email to STAT, the biotech disclosed that an interim analysis following 157 patient deaths found that participants on ivonescimab had a roughly 22% reduced risk of death, with a hazard ratio of 0.784. 

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