Akeso completes patient enrollment for Phase III Cadonilimab trial in high-risk HCC
Akeso, Inc. has announced the completion of patient enrollment for its Phase III cadonilimab trial (COMPASSION-22/AK104-306), marking a significant milestone in the clinical development of this PD-1/CTLA-4 bispecific antibody. The study evaluates cadonilimab therapy as an adjuvant treatment for high-risk hepatocellular carcinoma (HCC) in patients who have undergone curative resection or ablation.
With this progress, Akeso strengthens its position in liver cancer immunotherapy, reinforcing its efforts to address the high recurrence rates associated with hepatocellular carcinoma treatment. Another Phase III cadonilimab trial investigating its combination with lenvatinib therapy and transarterial chemoembolization (TACE) for advanced hepatocellular carcinoma treatment is also ongoing. These studies reflect the company’s broader strategy to develop more effective liver cancer treatments across different disease stages.
Why Is There a Need for New Hepatocellular Carcinoma Treatments?
Hepatocellular carcinoma remains a leading cause of cancer-related deaths worldwide, with an estimated 865,000 new cases diagnosed in 2024. China alone accounts for 370,000 of these cases, highlighting the disease’s significant burden in Asia. Despite advances in surgical techniques, post-surgical recurrence rates remain exceptionally high, with more than 70% of high-risk patients experiencing recurrence within five years.
Currently, there is no standard adjuvant therapy for hepatocellular carcinoma in clinical practice. Without effective post-surgical treatments, many patients face a significant risk of disease progression, making the development of cadonilimab therapy a potential breakthrough in liver cancer immunotherapy.
What Makes Cadonilimab a Potential Breakthrough in Liver Cancer Treatment?
Cadonilimab therapy is the first PD-1/CTLA-4 bispecific antibody developed by Akeso. Unlike traditional PD-1 inhibitor therapies, cadonilimab is designed to enhance immune system activation by simultaneously targeting two immune checkpoints, potentially leading to stronger anti-tumor responses in hepatocellular carcinoma treatment.
Data presented at leading oncology conferences have demonstrated cadonilimab’s efficacy in various settings. Findings from the 2023 European Society for Medical Oncology (ESMO) Asia Annual Meeting showed that cadonilimab combined with FOLFOX-HAIC therapy as a neoadjuvant treatment for multinodular hepatocellular carcinoma achieved a 100% disease control rate (DCR) with manageable safety outcomes.
Furthermore, research from the 2023 ESMO Congress highlighted that cadonilimab therapy combined with lenvatinib therapy as a first-line treatment for advanced hepatocellular carcinoma displayed superior anti-tumor activity compared to current liver cancer treatments. These promising results indicate that cadonilimab could become a key component of future hepatocellular carcinoma treatment strategies.
How Does Akeso’s Liver Cancer Pipeline Compare to Other Immunotherapies?
Akeso is actively expanding its oncology drug development pipeline beyond hepatocellular carcinoma. In addition to cadonilimab trials, the company has initiated studies across multiple cancer types, including gastric cancer, lung cancer, cervical cancer, and pancreatic cancer.
To date, cadonilimab therapy has secured regulatory approval for recurrent/metastatic cervical cancer and first-line gastric cancer treatment. Moreover, five Phase III trials involving hepatocellular carcinoma, non-small cell lung cancer (NSCLC), and gastric cancer are currently underway. Unlike many other PD-1 inhibitor therapies, cadonilimab has demonstrated potential across patients with high, low, or negative PD-L1 expression, broadening the eligible population for cancer immunotherapies.
What Role Does Akeso’s “IO 2.0 + ADC” Strategy Play in Cancer Treatment?
Akeso is pioneering an “IO 2.0 + ADC” strategy, integrating immune-oncology (IO) therapies with antibody-drug conjugates (ADCs) to develop more effective cancer treatments. The recent launch of the company’s first ADC therapy trial, AK138D1, marks a major advancement in this approach.
AK138D1, a HER3-targeting ADC therapy, is currently being evaluated in a Phase I trial for advanced malignancies in Australia. The ability to combine bispecific checkpoint inhibitors such as cadonilimab therapy with ADC therapy may lead to synergistic cancer treatment options, providing better tumor control and extended survival benefits.
Akeso remains the only global biopharmaceutical company with two approved bispecific checkpoint inhibitors—cadonilimab therapy (PD-1/CTLA-4) and ivonescimab therapy (PD-1/VEGF). This positions the company at the forefront of cancer immunotherapy innovation, offering next-generation treatment solutions that could reshape the standard of care.
What Are the Next Steps for Cadonilimab in Hepatocellular Carcinoma Treatment?
The completion of patient enrollment in the COMPASSION-22 trial is a crucial step toward potential regulatory submission. If cadonilimab therapy demonstrates strong clinical efficacy in reducing recurrence rates in high-risk hepatocellular carcinoma, it could become a first-in-class adjuvant treatment for this patient group.
With multiple cadonilimab trials progressing across different cancers, Akeso is advancing its efforts to expand immunotherapy access to a broader range of patients. As oncology drug development continues to evolve, cadonilimab therapy could emerge as a key player in the next generation of cancer treatments.
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