Akeso Announces Completion of Patient Enrollment in Phase III Trial of Cadonilimab for High-Risk Hepatocellular Carcinoma

Akeso Biopharma has proudly announced the completion of patient enrollment for its Phase III registrational clinical trial (COMPASSION-22/AK104-306). This pivotal study evaluates cadonilimab, the world’s first PD-1/CTLA-4 bispecific antibody developed independently by Akeso, as an adjuvant treatment for hepatocellular carcinoma (HCC). Specifically, it targets high-risk recurrent HCC following curative resection or ablation.

The successful completion of patient enrollment for the COMPASSION-22 trial marks a crucial step in the clinical development of cadonilimab as a treatment option for HCC. Additionally, another Phase III trial is underway to explore the combination of cadonilimab with lenvatinib and transarterial chemoembolization (TACE) for treating unresectable intermediate to advanced HCC. These efforts demonstrate Akeso’s commitment to providing patients with more effective treatment options across the full spectrum of HCC stages.

HCC: A Growing Global Health Challenge

Hepatocellular carcinoma remains one of the most common and deadly cancers worldwide, with approximately 865,000 new cases annually, 370,000 of which occur in China alone. HCC recurrence following surgery is a significant challenge, especially among patients with high-risk factors. The recurrence rate exceeds 70% within five years post-treatment, and despite this, no standard adjuvant treatments are currently available. This highlights the urgent need for effective therapies to reduce recurrence risks and extend survival.

Cadonilimab: A Breakthrough in Immunotherapy for HCC

Cadonilimab stands out as the world’s first approved bispecific immunotherapy for cancer, combining PD-1 and CTLA-4 inhibition in a single molecule. This groundbreaking approach aims to enhance the body’s immune response against tumors. Clinical studies have already shown cadonilimab’s significant efficacy and favorable safety profile in HCC treatment.

At the 2023 European Society for Medical Oncology (ESMO) Asia Annual Meeting, results from a study using cadonilimab with FOLFOX-HAIC as a neoadjuvant therapy for multinodular resectable HCC demonstrated an impressive 100% disease control rate. Additionally, at the 2023 ESMO Congress, cadonilimab combined with lenvatinib showed superior antitumor activity in advanced HCC patients, offering long-term survival benefits over existing treatments.

A Broad Clinical Development Pipeline

Akeso continues to expand cadonilimab’s clinical development across various malignancies. The drug is currently being investigated in over 23 clinical trials spanning 16 different cancer indications, including gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. It has already been approved for the treatment of recurrent/metastatic cervical cancer and first-line gastric cancer, with an sNDA for first-line cervical cancer currently under review.

The ongoing Phase III trials for cadonilimab across multiple indications, such as HCC, non-small cell lung cancer (NSCLC), and gastric cancer, continue to show promising results. Notably, studies across cervical cancer, gastric cancer, and NSCLC populations have demonstrated that cadonilimab provides significant efficacy benefits regardless of PD-L1 expression levels, thus broadening the eligible patient population who can benefit from immunotherapies.

Looking Ahead

Akeso remains committed to advancing cadonilimab’s clinical development to offer new hope for cancer patients around the globe. With ongoing studies and continued regulatory advancements, cadonilimab is poised to play a transformative role in the treatment of various cancers, bringing much-needed options to patients battling these life-threatening diseases.