Akeso reported positive overall survival results from the randomized, double-blind, multicenter, registrational Phase III HARMONi-2 study of ivonescimab versus pembrolizumab as first-line treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer. At a data cutoff of Aug. 20, 2026, median follow-up was 36 months and 234 overall survival events had occurred. In the intention-to-treat population, median overall survival was 30.8 months with ivonescimab and 22.6 months with pembrolizumab, producing a hazard ratio of 0.73, a 27% reduction in the risk of death, and P=0.009. The analysis used a prespecified O'Brien-Fleming spending function with a one-sided alpha of 0.0141 and met the prespecified statistical significance threshold. Benefits were generally consistent across subgroups, including squamous and non-squamous disease and different PD-L1 expression levels, with the strongest result in patients with PD-L1 TPS of at least 50%, where the hazard ratio was 0.58. The company said no apparent increase in bleeding risk was observed among high-risk squamous patients and reported no new safety signals. HARMONi-2 had previously met its primary progression-free survival endpoint, with median progression-free survival of 11.14 months versus 5.82 months and a hazard ratio of 0.51. The indication was approved in China in 2025. The study results were selected for a Late-Breaking Abstract and the official WCLC press program, with a formal oral presentation scheduled for Sept. 15 by Professor Caicun Zhou. Akeso said an international Phase III trial, HARMONi-7, is evaluating ivonescimab monotherapy against pembrolizumab in first-line PD-L1-high NSCLC. The company describes ivonescimab as using a dual immuno-oncology and anti-angiogenesis mechanism and says it is being developed for solid tumors beyond lung cancer.