Akeso broadens ivonescimab ambitions after biliary tract cancer win

Akeso reported a Phase III success for ivonescimab in advanced biliary tract cancer, expanding the drug’s late-stage evidence beyond non-small-cell lung cancer.

In the China-based HARMONi-GI1 trial, ivonescimab plus chemotherapy significantly improved overall survival versus AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy, the current immunotherapy standard in this setting.

The study also met key secondary endpoints for progression-free survival and objective response rate. Akeso called the overall-survival result clinically meaningful and statistically significant.

CEO Michelle Xia said the result supports ivonescimab’s broader potential across solid tumors. Akeso is also studying it in pancreatic cancer and triple-negative breast cancer.

Xia pushed back against skepticism surrounding fluctuations and interpretation of ivonescimab’s non-small-cell lung cancer datasets, arguing that critics may be overlooking the drug’s efficacy advantages.

Important caveat:
detailed efficacy, safety, and subgroup data from HARMONi-GI1 have not yet been released. The trial was conducted in a single region of China, so global regulatory and clinical significance remain to be established.