Ivonescimab Plus Chemotherapy Demonstrates Statistically Significant Overall Survival Benefit Compared to Durvalumab Plus Chemotherapy in First-Line Advanced Biliary Tract Cancer in Single-Region Trial Conducted by Akeso in China
HARMONi-GI1 Conducted in China by Akeso Is First Known Phase III Study in Advanced BTC to Demonstrate OS Superiority vs. Anti-PD-(L)1 Plus Chemotherapy
First Phase III Ivonescimab Readout beyond NSCLC Demonstrates Significant OS Benefit
Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that its partner Akeso Inc. announced positive topline results from the randomized Phase III HARMONi-GI1 study (AK112-309) evaluating ivonescimab plus chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC). HARMONi-GI1 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.
Akeso reported that, at a pre-specified interim analysis, the ivonescimab-based regimen achieved statistically significant and clinically meaningful superiority in the primary endpoint of overall survival (OS) compared to the durvalumab-based regimen. The study also met the key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR). Detailed results from this first readout of HARMONi-GI1, including safety and efficacy data, are expected to be presented at an upcoming medical congress and published in a peer-reviewed journal.
