#Hong Kong #liver cancer #Akeso #Cadonilimab

Cadonilimab: A New Hope in the Fight Against Liver Cancer

On August 4, 2025, Akeso, Inc. (9926.HK) announced a significant milestone in cancer research by receiving approval to commence its global Phase II registrational trial, designated COMPASSION-36/AK104-225. This trial is pivotal for evaluating cadonilimab, a groundbreaking bispecific antibody targeting PD-1 and CTLA-4, combined with lenvatinib for the treatment of advanced hepatocellular carcinoma (HCC), particularly in patients who have previously undergone treatment with atezolizumab and bevacizumab.

The Challenge of Hepatocellular Carcinoma

HCC is a pressing global health concern, with about 865,000 new cases of liver cancer reported in 2022 alone. The standard first-line treatment currently recommended involves the combination of atezolizumab and bevacizumab; however, for patients whose cancer progresses post-treatment, viable second-line options are alarmingly few. This gap in care underlines an urgent need for innovative therapeutic strategies.

The Promise of Cadonilimab

Cadonilimab stands out as Akeso’s first-in-class therapy specifically designed to counter treatment resistance. The intent behind this Phase II study is to discover if cadonilimab, in synergy with lenvatinib, can provide better outcomes than lenvatinib alone, particularly after the use of initial therapies. Previous results from international studies presented at notable congresses such as ESMO Asia and the ESMO Congress have shown encouraging outcomes, including a remarkable 100% disease control rate when cadonilimab was used as a neoadjuvant therapy in certain patient populations.

Global Collaboration for a Common Goal

The COMPASSION-36 trial is a collaborative effort endorsed by both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA). This global approach not only places Akeso in a pivotal position within the oncology landscape but also reflects a broader commitment to enhancing cancer care options worldwide. By addressing the shortcomings of existing therapies, cadonilimab offers hope for patients who have limited choices.

Dr. Yu Xia, Akeso's Founder and CEO, expressed enthusiasm about initiating this international study, emphasizing its role in tackling cancer immunotherapy resistance. The trial represents a crucial step towards meeting a significant unmet medical need in the management of HCC. Akeso's dedication to developing a range of promising therapies, from responsible pipeline management to strategic collaborations, positions them to be a vanguard of innovation in oncology.

Looking Ahead: Future Clinical Trials

Beyond the Phase II trial, Akeso is already gearing up for two additional pivotal studies involving cadonilimab. One focuses on adjuvant therapy for high-risk recurrence post-curative surgery for HCC, while the other explores the potential of combining cadonilimab with lenvatinib and transarterial chemoembolization (TACE) for treating unresectable HCC. Moreover, Akeso is investigating cadonilimab in combination with other therapies for various harder-to-target cancers, illustrating its versatility and potential efficacy.

Conclusion

As the COMPASSION-36 trial begins, the hope is that cadonilimab could revolutionize treatment options for patients with advanced liver cancer, providing new avenues for what has traditionally been a challenging and often fatal disease. With its innovative approach and commitment to overcoming resistance in cancer therapies, Akeso is poised to contribute significantly to the global fight against cancer, ultimately striving to enhance survival rates and improve the quality of life for countless patients around the world.