Akeso Presents P-II (COMPASSION-03) Trial Data on Cadonilimab for R/M Cervical Cancer at ESGO 2026

Why It Matters

The results demonstrate that cadonilimab can deliver durable survival benefits in heavily pre‑treated cervical cancer, potentially reshaping the immunotherapy landscape for this indication.

Key Takeaways

• Cadonilimab median OS 17.5 months in R/M cervical cancer
• 24‑month OS 40.9% regardless of PD‑L1 status
• Complete responders achieved 100% 24‑month OS
• Partial responders showed 63% 24‑month OS, 11.2‑month PFS
• Time to response ~1.85 months across response groups

Pulse Analysis

Cervical cancer remains a leading cause of cancer mortality among women worldwide, and therapeutic options after platinum‑based chemotherapy are limited. Immunotherapy has emerged as a promising avenue, yet most agents require PD‑L1 positivity to achieve meaningful benefit. Cadonilimab, a bispecific antibody that simultaneously blocks PD‑1 and CTLA‑4 pathways, aims to broaden efficacy by engaging multiple immune checkpoints, offering a potential solution for patients regardless of biomarker status.

The COMPASSION‑03 Phase‑II trial provides compelling evidence of cadonilimab’s activity. A median overall survival of 17.5 months surpasses historical benchmarks for this setting, and the 24‑month overall survival rate of 40.9% was observed without selection for PD‑L1 expression. Notably, patients achieving a complete response experienced a 100% survival rate at two years and an impressive 84.6% progression‑free rate at one year, underscoring the depth and durability of response. Partial responders also fared well, with a 63% two‑year survival and median progression‑free survival exceeding 11 months, highlighting the drug’s benefit across response spectra.

If these findings are confirmed in larger, randomized studies, cadonilimab could become a cornerstone therapy for recurrent or metastatic cervical cancer, challenging the current reliance on single‑checkpoint inhibitors. The data may accelerate regulatory discussions, attract partnership interest, and stimulate competitive development of next‑generation bispecifics. Moreover, the apparent independence from PD‑L1 status could simplify patient selection, expanding access and potentially improving outcomes for a broader patient population.