Summit Therapeutics highlights ivonescimab Phase III biliary tract cancer data

• Summit Therapeutics (NASDAQ:SMMT) announced that Phase III HARMONi-GI1 data for ivonescimab will be presented at ESMO 2026.
• The trial evaluated ivonescimab plus chemotherapy versus durvalumab plus chemotherapy in first-line advanced biliary tract cancer.
• Akeso reported statistically significant overall survival, progression-free survival and objective response rate improvements.

Summit Therapeutics (NASDAQ:SMMT) announced that data from the Phase III HARMONi-GI1 trial evaluating ivonescimab, a potential first-in-class investigational bispecific antibody, will be presented at the Presidential Symposium II during the European Society for Medical Oncology (ESMO) 2026 Congress.

The presentation is scheduled for October 25, 2026, during the Presidential Symposium session at the ESMO 2026 Congress in Madrid, Spain.

The HARMONi-GI1 study is evaluating ivonescimab in combination with chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC).

The Phase III trial was conducted in China as a single-region, multicenter study sponsored by Akeso.

All clinical data were generated, managed and analyzed by Akeso.

Akeso previously reported topline results from the study, stating that the ivonescimab-based treatment demonstrated statistically significant and clinically meaningful improvement in the primary endpoint of overall survival compared with the durvalumab-based regimen at a prespecified interim analysis.

The study also achieved key secondary endpoints, including progression-free survival and objective response rate.

Ivonescimab is a bispecific antibody designed to target both PD-1 and VEGF pathways, two mechanisms involved in tumor immune response and blood vessel formation.

In China, ivonescimab has received approval and is commercially available for certain non-small cell lung cancer indications.

However, ivonescimab remains investigational and has not been approved by regulatory authorities in Summit Therapeutics’ licensed territories, including the United States and Europe.