The HARMONi-2 trial, a randomized, double-blind study involving 234 overall survival events, revealed that ivonescimab monotherapy achieved a median overall survival of 30.8 months, compared to 22.6 months for pembrolizumab. These findings, presented by Professor Caicun Zhou, suggest a robust clinical benefit across both squamous and non-squamous histology populations. Notably, patients with a PD-L1 expression level of 50% or higher saw the most significant gains, with a 42% reduction in the risk of death.

A critical hurdle for many lung cancer therapies is the risk of bleeding in high-risk patients, particularly those with squamous tumors involving major vessels or necrosis. Ivonescimab demonstrated a favorable safety profile in these groups, showing no apparent increase in bleeding risks typically associated with anti-VEGF treatments. This development builds upon earlier 2024 interim results that confirmed superior progression-free survival for the drug. As Akeso continues its global clinical program, the study positions the dual-mechanism therapy as a potent alternative to existing PD-1/L1 inhibitors for patients with locally advanced or metastatic disease.