Summit Therapeutics (Nasdaq: SMMT) announced that data from the Phase III HARMONi-GI1 trial, sponsored by Akeso, Inc. (HKEX: 9926.HK), will be presented at the European Society for Medical Oncology 2026 Congress (ESMO 2026) in Madrid, Spain, on October 25, 2026, as part of the Presidential Symposium II.

The HARMONi-GI1 trial evaluates ivonescimab plus chemotherapy against durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC). The study is a single-region, multi-center Phase III trial conducted in China and sponsored by Akeso.

Akeso reported topline results on August 25, 2026, stating that at a pre-specified interim analysis, the ivonescimab-based regimen achieved statistically significant superiority in overall survival (OS) compared to the durvalumab-based regimen. The trial also met key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR).

Akeso describes HARMONi-GI1 as the first known Phase III study in advanced BTC to demonstrate OS superiority versus an anti-PD-(L)1 plus chemotherapy regimen.

Ivonescimab is a bispecific antibody that combines PD-1 blockade with anti-VEGF activity in a single molecule. In China, ivonescimab is approved for use in non-small cell lung cancer (NSCLC). It remains investigational and is not approved by any regulatory authority in Summit's license territories, which include the United States and Europe.

The ESMO 2026 presentation is scheduled for October 25, 2026, from 4:30 p.m. to 6:15 p.m. CET, with Jian Zhou, MD, of Shanghai, China, serving as presenter.