Akeso Presents Breakthrough Data on Cadonilimab for Cervical Cancer at 2025 SGO Meeting

Akeso's Innovative Approach to Locally Advanced Cervical Cancer

At the recent Society of Gynecologic Oncology (SGO) Annual Meeting, Akeso Inc. unveiled striking results from a phase III safety run-in study known as COMPASSION-18/AK104-305. This study investigates cadonilimab, a novel bispecific antibody targeting PD-1 and CTLA-4, used alongside concurrent chemoradiotherapy (CCRT) to treat locally advanced cervical cancer.

Traditionally, CCRT is the preferred treatment for cervical cancer that is locally advanced; however, approximately 30% to 40% of patients face recurrence or disease progression within five years following this standard treatment. Cadonilimab, characterized by its dual targeting mechanism, provides simultaneous blockade of critical immune checkpoint pathways. The National Medical Products Administration (NMPA) in China has approved it for patients with recurrent or metastatic cervical cancer who haven’t responded to prior platinum-based treatments.

The phase III COMPASSION-16 study reinforced the efficacy of cadonilimab, demonstrating significant improvements in both progression-free survival (PFS) and overall survival (OS) in patients grappling with persistent or recurrent cervical cancer. Following such compelling outcomes, a supplemental New Drug Application (sNDA) for cadonilimab as a first-line treatment option is currently undergoing regulatory scrutiny.

Efficacy Results at the SGO Meeting

During the SGO meeting, the results from COMPASSION-18 highlighted the high efficacy of cadonilimab in conjunction with CCRT during the safety run-in stage. This combination displayed a remarkable overall response rate (ORR) of 100% among evaluated patients; this included a complete response (CR) rate of 84.8% and a partial response (PR) rate of 15.2%. These results starkly outshine previous findings from similar studies, where response rates were markedly lower. The median duration of response (DoR) has not yet been determined, reflecting a hopeful outlook for ongoing patient responses.

The study captured a 12-month PFS rate for the overall patient cohort of 74.9%. Despite the median PFS not being reached, it suggests a promising trajectory for treatment outcomes. Furthermore, subgroup analyses indicated that certain patient demographics derived even greater benefits. For instance, patients with a PD-L1 expression score (CPS) of ≥1, an Eastern Cooperative Oncology Group (ECOG) performance status of 0, and those free from COVID-19 achieved 12-month PFS rates of 85%, 87.5%, and 81.3%, respectively.

Safety Profile and Future Potential

The safety profile of cadonilimab in combination with CCRT was promising, displaying good tolerability and manageable adverse events, with no treatment-related fatalities reported. No novel safety issues emerged through the study phase, underscoring the treatment’s acceptability.

The advancement of cadonilimab represents a significant step forward in the therapeutic landscape for both recurrent/metastatic and locally advanced cervical cancer. With robust evidence from the COMPASSION-18 study, the case for its use within a broader patient demographic strengthens as clinical advancements progress. The future for cadonilimab signals a revolutionary shift in cervical cancer treatment, potentially resulting in long-term survival advantages for many patients. As Akeso continues its clinical development, the implications of these positive results are set to reshape the standard approaches to cervical cancer care.