Clinical efficacy and safety of Cadonilimab immunotherapy in recurrent or metastatic gynecological malignancies: a retrospective study.

[BACKGROUND] Cadonilimab is a novel PD-1/CTLA-4 bispecific antibody approved for cervical cancer treatment in China in 2022. We conducted a retrospective study to investigate the efficacy and safety of Cadonilimab in patients with recurrent or metastatic gynecological malignancies.

[METHODS] We retrospectively enrolled 27 patients with recurrent or metastatic gynecological malignancies, confirmed by pathology or cytology between July 2022 and February 2025. All patients received at least two cycles of Cadonilimab. The primary endpoints were objective response rate and disease control rate according to RECIST v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

[RESULTS] In the enrolled population, the mPFS and mOS were 10.90 months (95% CI: 9.57-12.23) and 52.93 months (95% CI: 19.62-73.38), respectively. Among the first-line patients with advanced cervical cancer, ORR was 66.67% (10/15,95% CI, 41.71 to 84.82), DCR was 100.00% (15/15,95% CI 79.67 to 100.00), the mPFS and mOS were 15.9 months (95% CI: 7.72-24.08) and 46.5 months (95% CI: 19.62-73.38), respectively. There was no significant difference in PFS (P = 0.45, HR: 1.704, 95% CI: 0.38-7.70) and OS (P = 0.91, HR: 1.14, 95% CI: 0.11-11.46) between Cadonilimab-based chemotherapy with or without bevacizumab. In the responder population, 14 (51.85%) patients experienced at least one treatment-related adverse event (TRAE), only 1(3.70%) patient developed grade 3-4 adverse events. No treatment-related deaths occurred during the study.

[CONCLUSION] Cadonilimab-based chemotherapy with or without bevacizumab had a promising efficacy and manageable safety profile in the treatment of recurrent or metastatic gynecological malignancies.