Real-world safety and efficacy of cadonilimab mono or combination therapy in recurrent/persistent/metastatic cervical cancer in Wuxi City, China.

e17507 Background: Patients with recurrent/persistent/metastatic cervical cancer (R/P/M CC) have poor prognosis. Conventional radiotherapy and chemotherapy showed limited efficacy. Immune checkpoint inhibitor (ICI) has opened a new chapter of CC. Cadonilimab, as a bi-specific antibody, can simultaneously block the interaction of PD-1 and CTLA-4 with their ligands, promote tumor-specific T cell immune activation, and thus play a stronger anti-tumor effect with a better safety than combination of PD-1 and CTLA-4 ICIs. The objective of this study was to evaluate the efficacy and safety of cadonilimab in R/P/M CC in a real-world clinical setting in Wuxi City of China. Methods: This retrospective study reviewed R/P/M CC patients at the Affiliated Hospital of Jiangnan University from June 2022 to June 2024. Those received at least one cycle of cadonilimab were enrolled. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), overall patient disease control rate (DCR), and incidence of adverse events (AEs) (per CTCAE 5.0) were evaluated. Results: 38 patients were enrolled, with 33 squamous cell carcinoma (86.8%), 4 adenocarcinoma (10.5%) and 1 adenosquamous cell carcinoma (2.7%). Disease stage at initial diagnose were I (2 patients), II (5 patients), IIIA (3 patients), IIIB (5 patients), IIIC (14 patients) and IV (9 patients). ECOG PS were all 0-1. 30 patients (78.9%) had positive PD-L1 expression (CPS) and 18 cases (47.7%) had CPS ≥10. 4 patients received cadonilimab monotherapy, 22 patients received cadonilimab plus chemotherapy ± radiotherapy ± bevacizumab, the other 3 received a combination of bevacizumab. Among 35 patients with at least one image evaluation, 6 achieved CR, 18 had PR, 7 had SD, and 4 had PD. The objective response rate (ORR) was 68.6%, and the disease control rate (DCR) was 88.6%. Overall survival (OS) and progression-free survival (PFS) were not mature. 17, 13 and 5 patients were treated at 1 st line, 2 nd line and 3 rd line. The ORR were 100%, 46.2% and 20%, and DCR were 100%, 92.3% and 40% respectively. Among 38 patients, 32 patients (84.2%) reported AEs, of which 25 (65.7%) had grade 3-4 AEs, resulting in 3 discontinuation of treatment (7.8%) and 2 death (5.2%). Immune-related adverse events (irAE) occurred in 16 patients (42.1%), including hyperthyroidism (1), fatigue (3), hypothyroidism (4), rash (6), liver impairment (1), and adrenal hypofunction (1). Among them, 15 patients had grade 1 or 2 irAE, and only 1 patient (2.6%) had severe liver function impairment. This indicates that the overall AEs are mild, and the safety is controllable. Conclusions: Cadonilimab shows good efficacy in the treatment of R/P/M CC, and the AEs are relatively mild, suggesting that adding cadonilimab to conventional chemo/chemoradiotherapy can be an important strategy for improving clinical outcome of patients with R/P/M CC.