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Akeso Announces First Patient Dose in Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma
Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225). The trial will evaluate cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib versus lenvatinib alone for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with atezolizumab (a PD-L1 inhibitor) and bevacizumab.
About this update from Akeso, Inc.
[{"type":"text","content":"HONG KONG, Sept. 15, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225). The trial will evaluate cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib versus lenvatinib alone for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with atezolizumab (a PD-L1 inhibitor) and bevacizumab.","length":553,"tagName":"p"},{"type":"text","content":"COMPASSION-36 is the first global registrational Phase III trial of cadonilimab, currently ongoing in China, the U.S. and Europe. Its advancement represents a significant milestone in the global development and registration of cadonilimab, reflecting Akeso's commitment to advancing cancer immunotherapy and addressing the limited survival benefits associated with single-target therapies.","length":393,"tagName":"p"},{"type":"text","content":"Additional global multicenter registrational/Phase III clinical trials for cadonilimab are currently being prepared. Going forward, Akeso will continue to pursue a dual strategy of in-house development and open collaboration, leveraging high-quality global resources to accelerate the internationalization of cadonilimab and offer patients worldwide improved and more accessible treatment options.","length":397,"tagName":"p"},{"type":"text","content":"Currently, immune checkpoint inhibitor (IO) combination therapies have become the standard first-line treatment for various advanced malignancies. However, for patients worldwide whose disease progresses after IO combination therapy, there is a lack of effective second-line treatment options. The very limited second-line treatment options for advanced malignancies drive the critical need to explore new therapeutic strategies. Cadonilimab-based combination therapies have shown substantial potential in overcoming IO resistance across multiple tumor types.","length":559,"tagName":"p"},{"type":"text","content":"Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, with approximately 865,000 new cases of liver cancer reported globally in 2022. The combination of atezolizumab and bevacizumab (A+T regimen) is the standard fi...