Ivonescimab (SMT112) with chemotherapy - (HARMONi-2)

September 2, 2026: Summit Therapeutics (NASDAQ: SMMT) said partner Akeso reported positive overall survival results from the randomized, double-blind Phase III HARMONi-2 study of ivonescimab monotherapy versus pembrolizumab in locally advanced or metastatic PD-L1-positive NSCLC in China. In a preplanned OS analysis, a secondary endpoint, ivonescimab showed a statistically significant OS improvement versus pembrolizumab; detailed results are planned for presentation at an upcoming medical conference.

HARMONi-2 previously met its primary endpoint of PFS by IRRC, with HR 0.51 (95% CI: 0.38-0.69; p<0.0001), and benefit was reported across subgroups including PD-L1 low/high and squamous/non-squamous disease. Akeso received NMPA marketing authorization for ivonescimab in China in April 2025 based on HARMONi-2. Summit noted ivonescimab remains investigational in its territories, including the US and Europe.

Other cited catalysts for ivonescimab: Summit’s Phase III HARMONi BLA was accepted by FDA in January 2026, with a PDUFA date of November 14, 2026; HARMONi-7 enrollment began in 2025 in first-line PD-L1-high metastatic NSCLC; HARMONi-GI3 started in metastatic CRC in Q4 2025; and HARMONi-GU1 was initiated in 2026 in first-line urothelial carcinoma, with global site activations planned by Q4 2026.