Akeso Inc. presented final overall-survival results from the randomized, double-blind, multicenter Phase III HARMONi-2 study at the 2026 World Conference on Lung Cancer. The trial evaluated first-line ivonescimab against pembrolizumab in patients with PD-L1-positive, locally advanced or metastatic non-small cell lung cancer. After a median follow-up of 36 months and 234 deaths, ivonescimab produced median overall survival of 30.8 months versus 22.6 months, with a hazard ratio of 0.73 and a P value of 0.009, representing a 27% reduction in the risk of death. Two-year overall survival was 57.9% versus 48.0%, while three-year survival was 45.0% versus 33.1%. Benefits were observed across prespecified subgroups, including a hazard ratio of 0.58 among patients with PD-L1 tumor proportion scores of at least 50% and 0.65 in squamous disease. HARMONi-2 previously met its progression-free-survival endpoint, with median PFS of 11.14 months versus 5.82 months. Akeso said the treatment showed no new safety signals or apparent increase in bleeding risk among high-risk squamous patients. The indication was approved in China in 2025, and an international Phase III study, HARMONi-7, is evaluating ivonescimab against pembrolizumab in first-line PD-L1-high NSCLC.