Akeso's Ivonescimab Beats Pembrolizumab on Overall Survival in Phase III HARMONi-2 NSCLC Trial

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Akeso announced positive overall survival results from the Phase III HARMONi-2 study of ivonescimab versus pembrolizumab as first-line treatment for PD-L1-positive advanced non-small cell lung cancer, presented at the 2026 World Conference on Lung Cancer. In the intention-to-treat population, ivonescimab monotherapy achieved a median overall survival of 30.8 months versus 22.6 months for pembrolizumab, an HR of 0.73 and a 27% reduction in the risk of death. The benefit was consistent across prespecified subgroups, with the PD-L1 TPS 50% or higher subgroup showing an HR of 0.58, a 42% reduction in the risk of death, and the squamous subgroup showing an HR of 0.65, a 35% reduction. No apparent increase in bleeding risk was observed among high-risk squamous patients, 45.5% of the study population, including those with central tumors, tumor cavitation or necrosis, and tumors encasing major vessels. HARMONi-2 is the first randomized, double-blind, controlled Phase III study to show statistically significant positive overall survival and progression-free survival results versus pembrolizumab, following a median PFS of 11.14 months versus 5.82 months. A separate Phase III trial, HARMONi-7, evaluating ivonescimab monotherapy versus pembrolizumab in PD-L1-high NSCLC, is ongoing.

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Ivonescimab beat pembrolizumab on overall survival in the Phase III HARMONi-2 NSCLC trial, a positive clinical readout for Akeso's drug.

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