Akeso's Ivonescimab Tops Imfinzi in BTC Trial

Akeso's ivonescimab has achieved statistically significant and clinically meaningful superiority over AstraZeneca's Imfinzi in a Phase III trial for advanced biliary tract cancer (BTC). The result, announced by China-based Akeso Inc., marks the first known overall survival superiority result over an anti-PD-(L)1 plus chemotherapy regimen in BTC. Ivonescimab is a bispecific antibody that blocks PD-1 and VEGF within a single tetravalent molecule.

The trial, HARMONi-GI1 (AK112-309), was conducted and sponsored by Akeso in China, with all data generated and analyzed by the company. Ivonescimab remains investigational and unapproved outside of China, where it is already approved for multiple non-small cell lung cancer (NSCLC) indications.

The result carries particular weight in BTC because previous trials have shown modest overall survival gains over chemotherapy alone. Akeso described HARMONi-GI1 as the first known study to demonstrate superiority over an anti-PD-(L)1 plus chemotherapy backbone in this disease.