Clinical efficacy and safety of cadonilimab in the treatment of advanced gynecological malignancies: A retrospective, real-world study.

e17652 Background: Cadonilimab, recognized as the most rapidly developed Chinese bispecific antibody in the field of cervical cancer, received marketing approval in China in 2022 due to its promising results in treating patients with recurrent or metastatic cervical cancer who have progressed following platinum-based chemotherapy. Whether administered as monotherapy or in combination with chemotherapy and other targeted therapies, it has demonstrated significant anti-tumor effects. Consequently, we conducted a study to investigate the safety and efficacy of Cadonilimab, combined with and without chemotherapy or bevacizumab treatment, in patients with recurrent / metastatic gynecological malignancies. Methods: We retrospectively enrolled 60 patients with recurrent / metastatic gynecological malignant tumors, confirmed by pathology or cytology, at Guizhou Provincial People's Hospital and Guizhou Provincial Cancer Hospital from July 2022 to December 2024. All patients received at least two cycles of Cadonilimab, either monotherapy or combination with chemotherapy and/or bevacizumab. Including 46 cases of cervical cancer (76.7%）and 14 cases of other gynecological malignancies (23.3%)The primary endpoints were the investigator-confirmed objective response rate (ORR) and disease control rate (DCR) . Secondary endpoints included progression-free survival (PFS) and safety. Results: 56 patients were included in the efficacy analysis. Among these, 2 patients (3.6%) achieved a complete response (CR), 24 patients (42.9%) achieved a partial response (PR), 26 patients (46.4%) developed stable disease (SD), and 4 patients (7.1%) experienced progressive disease (PD). Overall, ORR was 46.4%,DCR was 92.9%. In the study population, there were 16 first-line patients with advanced cervical cancer, ORR was 81.3%,DCR was 93.8%; There were 30 second-line patients, ORR was 36.7%,DCR was 90%. A total of 41 patients (73.2%) reported at least one treatment-related adverse events (TRAEs), with the most common being anemia (71.4%), nausea (28.6%), and myelosuppression (25%). 9 patients (16.1%) experienced G3-4 TRAEs, with 5 patients (8.9%) affected by anemia and 4 patients (7.1%) affected by myelosuppression. Additionally, 13 patients (23.2%) developed immune-related adverse events of G1-2. No treatment-related deaths occurred during the study. Conclusions: Cadonilimab with or without chemotherapy/bevacizumab had a promising antitumor activity and manageable safety profile in the treatment of recurrent/metastatic gynecological malignancies.