Akeso Launches Global Phase II Trial of Cadonilimab in Advanced Liver Cancer

Akeso, Inc. announced dosing of the first patient in its global Phase II registrational trial (COMPASSION-36/AK104-225), testing cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, with lenvatinib versus lenvatinib alone in previously treated advanced hepatocellular carcinoma (HCC).

Expanding Clinical Strategy

Akeso said the study marks a major milestone in cadonilimab’s global development. With ongoing Phase III programs across China, the U.S., and Europe, the company plans further multinational trials and will combine in-house development with global collaborations to accelerate access.

Addressing Unmet Need in Oncology

While immune checkpoint inhibitor combinations are standard first-line care, options for patients who progress after such therapies remain scarce. Cadonilimab-based regimens have shown strong potential to overcome resistance and improve outcomes across multiple tumor types.