Summit Therapeutics Inc. announced on September 13, 2026, that its partner, Akeso Inc., will present updated overall survival data from the Phase III HARMONi-2 clinical trial at the International Association for the Study of Lung Cancer’s 2026 World Conference on Lung Cancer in Seoul. The presentation is scheduled for Tuesday, September 15, 2026.
The HARMONi-2 study, designated AK112-303, is a randomized, double-blind trial conducted in China. It evaluated ivonescimab monotherapy against pembrolizumab monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at a score greater than 1%. The study is sponsored by Akeso.
According to the press release attached to the filing, the interim analysis of overall survival showed ivonescimab reduced the risk of death by 27% compared to pembrolizumab. The hazard ratio (HR) was 0.73 (95% CI: 0.57, 0.95; p=0.009). The median overall survival was 30.8 months for ivonescimab and 22.6 months for pembrolizumab, with a median follow-up of 36.0 months.
Subgroup analyses indicated a hazard ratio of 0.58 (95% CI: 0.38, 0.89) in the PD-L1 high expression subgroup (Score ≥50%). The safety profile continued to show an acceptable and manageable risk of treatment-related adverse events, with no new safety signals noted in this data cut.
Based on the HARMONi-2 results, ivonescimab received marketing authorization from China’s National Medical Products Administration (NMPA) in April 2025. Summit Therapeutics is currently conducting the global Phase III HARMONi-7 study, which is evaluating ivonescimab monotherapy against pembrolizumab monotherapy in patients with PD-L1 high-expressing metastatic NSCLC.
