Ivonescimab - (HARMONi-GI3)

August 25, 2026: Summit Therapeutics (NASDAQ: SMMT) said partner Akeso reported positive topline results from the randomized Phase III HARMONi-GI1 study (AK112-309) in first-line advanced biliary tract cancer in China. Ivonescimab plus chemotherapy showed statistically significant and clinically meaningful overall survival superiority versus durvalumab plus chemotherapy at a prespecified interim analysis, and also met key secondary endpoints of progression-free survival and objective response rate. Detailed efficacy and safety data are planned for presentation at an upcoming medical congress and publication in a peer-reviewed journal.

The release says this is the first known Phase III study in advanced BTC to show OS superiority versus an anti-PD-(L)1 plus chemotherapy regimen, and the first Phase III ivonescimab readout beyond NSCLC to show a significant OS benefit.

Other catalysts/status updates mentioned: ivonescimab is approved in China for NSCLC but remains investigational in Summit’s territories, including the U.S. and Europe. For Summit’s Phase III HARMONi study in EGFR-mutated NSCLC, a BLA was accepted by FDA in January 2026, with a PDUFA date of November 14, 2026. Summit also notes ongoing Phase III programs HARMONi-3 (1L metastatic NSCLC), HARMONi-7 (high PD-L1 NSCLC), HARMONi-GI3 (1L metastatic CRC), and Phase II/III HARMONi-GU1 (1L urothelial carcinoma), with global site activations for HARMONi-GU1 planned by Q4 2026.