What changed
In the HARMONi-2 Phase III trial conducted in China, ivonescimab monotherapy achieved a median overall survival of 30.8 months versus 22.6 months for pembrolizumab, an 8.2-month improvement, with a stratified hazard ratio of 0.73 (95% CI: 0.57, 0.95; p=0.009) in the intention-to-treat population of 398 patients at a median follow-up of 36.0 months. The PD-L1 high expression subgroup showed a hazard ratio of 0.58 (95% CI: 0.38, 0.89). Serious treatment-related adverse events occurred in 59 patients (29.9%) on ivonescimab versus 43 (21.6%) on pembrolizumab, while discontinuations were 8 (4.1%) versus 10 (5.0%). Summit is conducting the global Phase III HARMONi-7 study in PD-L1 high-expressing NSCLC.
Why it matters
In the HARMONi-2 Phase III trial conducted in China, ivonescimab monotherapy achieved a median overall survival of 30.8 months versus 22.6 months for pembrolizumab, an 8.2-month improvement, with a st