Safety and clinical activity of cadonilimab, an anti PD-1/CTLA-4 bispecific antibody, for patients with persistent, recurrent, or metastatic cervical cancer (R/M CC): A retrospective, real-world study.

e17522 Background: Recurrent, metastatic or persistent cervical cancer (R/M cc) patients have limited treatment options. Immune chechpoint inhibitors targeting PD-1 or CTLA-4 individually have shown substantial clinical benefits in the treatment of malignancies, cadonilimab monotherapy has shown promising efficacy and tolerable toxicity in pre-treated R/M CC (NCT04380805).We aimed to assess the safety and clinical activity of Cadonilimab combination therapy(including chemotherapy, radiotherapy, targeted therapy, or immunotherapy) in patients with advanced r/m CC. Methods: Pts (FIGO stage IIIc2r-IVb CC) previously treated with or not candidates for standard therapy, aged ≥ 18 years, with ECOG PS ≤ 2, and measurable (RECIST 1.1) or evaluable disease, were enrolled.All patients received at least one dose of Cadonilimab (10mg/kg, Q3W or 6mg/kg Q2W), 32 patients received concurrent radiotherapy, 66 patients received concurrent chemotherapy, 57patients received targeted therapy, and 4 patients received local injections of oncolytic virus.Immune-related adverse events (irAEs), objective response rate (ORR) and disease control rate (DCR) were evaluated. Results: 82 pts were enrolled from Jul 13, 2022, to Dec 20, 2023. As of Jan 10, 2024, we assessed safety in all pts and efficacy in pts with at least one tumor assessment result. IrAEs of any grade occurred in 46 (56.1%) pts. Grade ≥ 3 irAE occurred in 15 (18.3%) pts. The most frequent were irAEs hypothyroidism (28,34%), Rash (5,6%), infusion reaction (3,3.7%), hepatitis (2,2.4%), there were no toxic deaths reported. The ORR was 70.4% (57/81,95% CI:60.2%-80.5%) with 23 (28.4%) CR,34 PR, 5 SD, and the DCR was 76.5% (62/81,95% CI:67.1%-86.0%). Especially, 6 Pts had previously received immunotherapy, and 2 of them achieved PR. mPFS and mOS data are not mature by cut-off date. Conclusions: Cadonilimab combined with standard therapy (including radiotherapy, chemotherapy and targeted therapy) was well tolerated, with encouraging antitumor activity in pts with R/M CC. Pts who had failed checkpoint inhibitor therapy may still benefit from cardonilimab. Meanwhile, long-term safety and activity evaluation still needs following up.