Akeso's Cadonilimab: A Promising Adjuvant Therapy for High-Risk Recurrent Hepatocellular Carcinoma

Akeso, Inc. (9926.HK), a leading biopharmaceutical company, recently announced the completion of patient enrollment in its Phase III clinical trial (COMPASSION-22/AK104-306) evaluating cadonilimab, the world's first approved bispecific immunotherapy for cancer, as an adjuvant treatment for high-risk recurrent hepatocellular carcinoma (HCC). This significant milestone brings the company one step closer to providing a more effective treatment option for patients with this aggressive form of liver cancer.

HCC is one of the most common malignant tumors globally, with a high recurrence rate after surgery, especially in patients with high-risk factors. The five-year recurrence rate exceeds 70%, and currently, no standard adjuvant treatment exists for HCC in clinical practice. Identifying effective adjuvant therapies to reduce recurrence risk and extend survival is a critical unmet need in HCC treatment.

Cadonilimab, a PD-1/CTLA-4 bispecific antibody, has shown promising results in previous studies. Research presented at the 2023 ESMO Congress demonstrated that cadonilimab combined with lenvatinib as a first-line treatment for advanced HCC showed superior antitumor activity compared to approved therapies, effectively controlling tumor progression and offering long-term survival benefits over current treatment options.

The COMPASSION-22/AK104-306 trial is a Phase III registrational clinical trial evaluating cadonilimab as an adjuvant treatment for HCC with high recurrence risk following curative resection or ablation. The trial's primary endpoint is disease-free survival (DFS), and the secondary endpoints include overall survival (OS), objective response rate (ORR), and safety. With the completion of patient enrollment, the trial is now in the follow-up phase, during which the data will be analyzed to assess the efficacy and safety of cadonilimab.



The expected outcomes of the COMPASSION-22/AK104-306 trial could significantly influence the future of adjuvant therapy for HCC in several ways. If the trial demonstrates that cadonilimab, as an adjuvant therapy, significantly improves RFS and OS compared to the control group, it could become a new standard of care for high-risk HCC patients. This would provide a more effective option for preventing disease recurrence and extending patient survival. Additionally, if cadonilimab shows efficacy in the high-risk population, it could expand the eligible patient population for adjuvant therapy, benefiting more HCC patients.

Moreover, the success of cadonilimab in the COMPASSION-22/AK104-306 trial would validate the bispecific antibody approach for HCC treatment, paving the way for further research and development of bispecific antibodies for other cancer indications. This could also contribute to Akeso's competitive position in the global biopharmaceutical market by expanding its pipeline and market potential.

In conclusion, the completion of patient enrollment in the COMPASSION-22/AK104-306 trial marks a significant milestone in the clinical development of cadonilimab for HCC. The expected outcomes of this trial could revolutionize the future of adjuvant therapy for HCC by providing a more effective treatment option, expanding the eligible patient population, validating the bispecific antibody approach, and contributing to Akeso's competitive position in the global biopharmaceutical market. As the trial progresses, investors should closely monitor the developments surrounding cadonilimab and its potential impact on the HCC treatment landscape.