Akeso Completes Patient Enrollment in Phase III Trial of Cancer Drug Cadonilimab for High-Risk Recurrent Hepatocellular Carcinoma

Akeso’s Phase III Clinical Trial Completion: A Breakthrough in Hepatocellular Carcinoma Treatment

Hong Kong, March 5, 2025 – Akeso, Inc. (9926. HK), a leading biotechnology company based in Hong Kong, is thrilled to announce a significant milestone in the development of a potential game-changer for hepatocellular carcinoma (HCC) patients. The Company has successfully completed patient enrollment for its Phase III registrational clinical trial, named COMPASSION-22/AK104-306.

About the Clinical Trial

The COMPASSION-22/AK104-306 trial focuses on evaluating the efficacy and safety of cadonilimab, Akeso’s proprietary PD-1/CTLA-4 bispecific antibody, as an adjuvant treatment for HCC patients with high recurrence risk following curative resection or ablation. This trial is the first of its kind to utilize a PD-1/CTLA-4 bispecific antibody, independently developed by Akeso, in this indication.

Impact on Patients

The successful completion of patient enrollment in the COMPASSION-22/AK104-306 trial marks a potential turning point for HCC patients with high recurrence risk. Current treatment options for this patient population are limited, with no approved adjuvant therapies available. If the clinical trial results demonstrate positive outcomes, cadonilimab could offer these patients a new hope for improved survival and reduced risk of recurrence.

Global Implications

Beyond the immediate impact on HCC patients, the successful development of cadonilimab as an adjuvant treatment could have far-reaching implications for the global healthcare industry. HCC is a significant cause of cancer-related deaths worldwide, with an estimated 782,000 new cases and 745,000 deaths reported in 2020. The availability of a safe and effective adjuvant therapy could save countless lives and reduce the overall burden of HCC on healthcare systems worldwide.

Future Prospects

As Akeso moves forward with the COMPASSION-22/AK104-306 trial, the Company remains committed to advancing the science of cancer immunotherapy. The successful completion of this trial could pave the way for future research and development efforts in the field, ultimately leading to more effective and personalized treatments for various types of cancer.

  • Akeso completes patient enrollment for Phase III clinical trial
  • Cadonilimab, a PD-1/CTLA-4 bispecific antibody, is evaluated as an adjuvant treatment for HCC
  • No approved adjuvant therapies currently available for this patient population
  • Positive trial results could offer new hope for improved survival and reduced recurrence risk
  • Global implications include reduced healthcare burden and potential for more effective cancer treatments

Conclusion

The successful completion of patient enrollment for Akeso’s Phase III clinical trial marks a significant step forward in the development of cadonilimab as a potential adjuvant treatment for hepatocellular carcinoma patients with high recurrence risk. The potential implications for these patients and the global healthcare industry are immense, as current treatment options are limited, and HCC remains a leading cause of cancer-related deaths worldwide. As Akeso continues to advance the science of cancer immunotherapy, the future holds the promise of more effective and personalized treatments for various types of cancer.

Stay tuned for updates on the COMPASSION-22/AK104-306 trial and the continued progress of cadonilimab as a potential game-changer in the fight against HCC.

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