Biopharmaceutical company Akeso Inc (HKEX:9926) announced on Wednesday that a pre-specified interim analysis in the HARMONi-2 (AK112-303) trial, as assessed by the Independent Data Monitoring Committee, met the key secondary endpoint of overall survival.
According to the company, the results demonstrated that ivonescimab showed statistically significant and clinically meaningful improvement over pembrolizumab.
HARMONi-2 is a randomised, double-blind, multicentre, registrational Phase III trial evaluating ivonescimab, Akeso's first-in-class PD-1/VEGF bispecific antibody, versus pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1 (TPS greater than 1%).
Detailed data from the interim analysis of overall survival will be presented at an upcoming international medical conference and published in a peer-reviewed journal.
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Akeso's ivonescimab meets overall survival endpoint in interim analysis of Phase III HARMONi-2 study