HONG KONG, March 21, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) presented promising phase III safety run-in results from the COMPASSION-18/AK104-305 study, at the 2025 Annual Meeting of the Society of Gynecologic Oncology (SGO). The study evaluates the global first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab (AK104), in combination with concurrent chemoradiotherapy (CCRT) for the treatment of locally advanced cervical cancer.

Currently, CCRT is the standard of care for locally advanced cervical cancer, but approximately 30%-40% of patients experience relapse or disease progression within five years. Cadonilimab, with its unique dual-target mechanism, is designed to simultaneously inhibit the PD-1 and CTLA-4 immune checkpoint pathways. It has received approval from the National Medical Products Administration (NMPA) in China for use in patients with recurrent or metastatic cervical cancer who have failed prior platinum-based chemotherapy. The Phase III COMPASSION-16 study further confirmed that cadonilimab, when combined with platinum-based chemotherapy (with or without bevacizumab), significantly improves progression-free survival (PFS) and overall survival (OS) in patients with persistent, recurrent, or metastatic cervical cancer. Based on these compelling results, the supplemental New Drug Application (sNDA) for cadonilimab as a first-line treatment for persistent, recurrent, or metastatic cervical cancer is currently under regulatory review.

At this year's SGO, data from the COMPASSION-18 study highlighted the exceptional efficacy seen in patients receiving cadonilimab in combination with CCRT during the safety run-in phase. The results demonstrate the considerable therapeutic potential of cadonilimab combined with CCRT for locally advanced cervical cancer. The study included a more challenging patient cohort, with a notably higher proportion of patients having PD-L1 CPS <1 (38.2%) and an ECOG performance status of 1 (52.9%) compared to other similar studies.

• Overall Response Rate (ORR): The evaluable patients achieved a remarkable ORR of 100%, with a complete response (CR) rate of 84.8% and a partial response (PR) rate of 15.2%, which significantly outperformed data from other comparable studies. The median duration of response (DoR) has yet to be reached.
• Progression-Free Survival (PFS): While the median PFS has not been reached, the 12-month PFS rate was 74.9%.
• Subgroup Analysis: Patients with PD-L1 CPS ≥1, ECOG 0, and those not infected with COVID-19 derived even greater benefit from the treatment, with 12-month PFS rates of 85%, 87.5%, and 81.3%, respectively.
• Safety Profile: Cadonilimab combined with CCRT exhibited a favorable safety profile, demonstrating good tolerability and manageable adverse events. Notably, there were no treatment-related deaths (TRAE) and no new safety concerns were identified.

Cadonilimab is making significant progress in treating both recurrent/metastatic and locally advanced cervical cancer, establishing a comprehensive therapeutic approach. The positive results from the COMPASSION-18 study reinforce its potential in a broader patient population. As clinical development continues, cadonilimab is set to redefine cervical cancer treatment, offering long-term survival benefits to more patients.