Akeso, Inc. announced that the Company presented the promising phase II results of cadonilimab (a tetravalent PD-1/CTLA-4 bispecific antibody) and Lenvatinib (Len) combined with TACE for the treatment of mid- and advanced-stage hepatocellular carcinoma (HCC) in a poster at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco, California. Based on the encouraging results, the company plans to further explore this combination therapy for the mid- and advanced-stage HCC indication. AK104-216 is an open-label, multicenter phase II trial (NCT05319431).

As of August 15, 2023, 60 patients received at least once Cadonilimab and the median duration of follow-up was 5.1 months. Cadonilimab and Lenvatinib combined with TACE showed great tumor response: The ORR and DCR were 85.0% and 95% per mRECIST. 15% subjects achieved CR and 70% subjects achieved PR.

The median PFS was not reached, 6-month PFS rate and 9-month PFS rate was 75.6% and 60.4%, respectively. Cadonilimab and Lenvatinib combined with TACE showed manageable safety in mid- and advanced-stage HCC. HCC typically has an insidious onset, with over 80% of patients being diagnosed in the middle to late stages of the disease.

The low rate of radical resection and poor overall prognosis further compound the challenges associated with HCC. Transarterial chemoembolization (TACE) is a standard therapy recommended for intermediate-stage unresectable hepatocellular carcinoma (uHCC) but has unsatisfying tumor control due to the increasing risk of tumor angiogenesis. Immune-checkpiont inhibitors, in combination with targeted therapy and local therapy, have been developed as promising treatment for mid- and advanced-stage HCC.

Cadonilimab and Lenvatinib combined with TACE have demonstrated promising efficacy and manageable toxicity in treating mid- and advanced-stage HCC. Patients can expect to benefit from tumor progression control after TACE and lasting survival. Akeso is actively preparing a clinical study of this therapy in mid- and advanced-stage HCC, which will be registrational.

Furthermore, Akeso is accelerating the progress of the registrational Phase III clinical study of cadonilimab monotherapy for postoperative adjuvant treatment of hepatocellular carcinoma. The enrollment for this study is expected to be completed in 2024.