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

HONG KONG, March 5, 2025 - Akeso, Inc. has achieved a significant milestone by completing patient enrollment for its Phase III clinical trial, COMPASSION-22/AK104-306. This trial is investigating cadonilimab, a pioneering bispecific antibody targeting PD-1 and CTLA-4, as an adjuvant therapy for hepatocellular carcinoma (HCC) in patients who face a high risk of recurrence following surgical resection or ablation.

The culmination of patient enrollment in this trial represents a critical progression in the development of cadonilimab for liver cancer. Besides this study, Akeso is conducting another Phase III trial that evaluates cadonilimab in conjunction with lenvatinib and transarterial chemoembolization (TACE) to treat intermediate to advanced unresectable HCC. The comprehensive investigation of combination therapies involving cadonilimab aims to present more effective treatment methodologies for both early and advanced stages of HCC.

Globally, HCC is one of the most prevalent malignant tumors. In 2024, there were approximately 865,000 new liver cancer cases worldwide, with 370,000 reported in China alone. Post-operative recurrence remains a significant challenge, especially in high-risk patients, with a five-year recurrence rate surpassing 70%. Presently, there is no established adjuvant treatment for HCC in clinical settings, highlighting an urgent need for effective therapies to reduce recurrence risk and enhance patient survival.

Cadonilimab is recognized as the first approved bispecific immunotherapy for cancer. Prior research has demonstrated its remarkable efficacy and safety in treating liver cancer. Notably, data shared at the 2023 European Society for Medical Oncology (ESMO) Asia Annual Meeting revealed that when used with FOLFOX-HAIC as a neoadjuvant therapy for resectable multinodular HCC, cadonilimab achieved a 100% disease control rate with manageable safety levels. Additionally, findings from the 2023 ESMO Congress indicated that cadonilimab, in combination with lenvatinib as a first-line treatment for advanced HCC, showed superior antitumor activity compared to existing therapies, effectively controlling tumor progression and offering extended survival benefits.

Akeso is committed to advancing the clinical development of cadonilimab for various malignant tumors to expand treatment options for patients globally. Currently, cadonilimab is being evaluated in over 23 clinical studies across 16 indications, including gastric, lung, liver, cervical, and pancreatic cancers. It has already received approval for use in treating recurrent/metastatic cervical cancer and first-line gastric cancer, with a supplemental new drug application (sNDA) under review for first-line cervical cancer. Furthermore, five Phase III trials are underway for HCC, non-small cell lung cancer (NSCLC), and gastric cancer. Studies have demonstrated that cadonilimab provides significant efficacy benefits across multiple indications, regardless of varying PD-L1 expression levels (high, low, or negative), thus broadening the spectrum of patients who can benefit from cancer immunotherapies.