#China #Hong Kong #Akeso #Cadonilimab #HCC

Akeso Completes Patient Enrollment in Phase III Clinical Trial of Cadonilimab

Akeso, Inc. (HKEX: 9926), a leading biopharmaceutical company, recently announced a significant milestone in its clinical development program. The company has successfully completed patient enrollment for the Phase III registrational clinical trial named COMPASSION-22/AK104-306. This trial examines cadonilimab, which is heralded as the world's first PD-1/CTLA-4 bispecific antibody independently developed by Akeso. The focus of this trial is on the adjuvant treatment of high-risk recurrent hepatocellular carcinoma (HCC) that follows curative surgery or ablation.

HCC is one of the most prevalent malignant tumors globally, with about 865,000 new cases reported worldwide in 2024, of which 370,000 occur in China alone. The recurrence rate of HCC post-surgery is alarmingly high, especially among patients with significant risk factors, where five-year recurrence rates can exceed 70%. Consequently, there is an urgent and critical need for effective adjuvant therapies that can mitigate recurrence and improve survival rates for these patients. Currently, there is no standard post-operative treatment available for HCC, further emphasizing the importance of the COMPASSION-22/AK104-306 trial.

The completion of patient enrollment not only marks a critical point in cadonilimab's clinical journey for HCC but also paves the way for the potential establishment of new treatment protocols aimed at reducing recurrence risks. In addition to this pivotal Phase III study, Akeso is concurrently progressing another Phase III trial that explores the combination of cadonilimab with lenvatinib and transarterial chemoembolization (TACE) for patients diagnosed with unresectable intermediate to advanced HCC.

The extensive investigation of cadonilimab, particularly in combination with other therapies, is anticipated to provide more effective treatment avenues for a broad spectrum of HCC patients, ranging from early-stage to more advanced forms of the disease.

In recent studies featured at the 2023 European Society for Medical Oncology (ESMO) Asia Annual Meeting, cadonilimab demonstrated critical efficacy when paired with FOLFOX-HAIC as a neoadjuvant treatment for resectable multinodular HCC. Remarkably, this combination achieved a 100% disease control rate (DCR) while maintaining a manageable safety profile. Furthermore, data presented at the 2023 ESMO Congress highlighted that cadonilimab, used alongside lenvatinib as a first-line treatment, showed superior anti-tumor activity compared to current approved therapies, leading to effective tumor control and prolonged survival benefits for patients suffering from advanced HCC.

Akeso remains committed to advancing the cadonilimab clinical development pathway across various malignant conditions. Presently, cadonilimab is featured in over 23 clinical trials covering 16 different indications, which include gastric cancer, lung cancer, cervical cancer, and pancreatic cancer. It has acquired approval for the treatment of recurrent/metastatic cervical cancer and first-line gastric cancer. A supplemental new drug application (sNDA) for cadonilimab as a treatment for first-line cervical cancer is currently under review, signifying the growing significance of this innovative agent.

Currently, five Phase III trials are underway focused on HCC, non-small cell lung cancer (NSCLC), and gastric cancer. Research data has shown that cadonilimab presents substantial efficacy benefits across diverse patient cohorts, irrespective of the PD-L1 expression levels, whether high, low, or negative. This broadens the pool of eligible patients who can potentially benefit from cancer immunotherapies, thus enhancing the treatment landscape significantly.

About Akeso

Founded in 2012, Akeso is at the forefront of biopharmaceutical innovation, concentrating on the research, development, manufacture, and commercialization of groundbreaking biological medicines. The firm employs an integrated research and development innovation system featuring the ACE Platform and the unique Tetrabody technology for bispecific antibody development. Akeso’s commitment to creating affordable therapeutic antibodies aims to deliver significant healthcare advancements to patients globally, thereby contributing to the establishment of Akeso as a leading global biopharmaceutical enterprise.

For further insights into Akeso's missions and product pipeline, visit Akeso's Corporate Profile. Follow them on LinkedIn for the latest updates.