Clinical efficacy and safety of cadonilimab immunotherapy in patients with advanced cervical cancer: A retrospective study.

e17519 Background: For patients with recurrent or metastatic cervical cancer, especially those with negative PD-L1 expression, there is a lack of effective treatment and often indicate poor prognosis. A multicenter retrospective study was conducted to evaluate the safety and antitumor activity of cadonilimab in recurrent or metastatic cervical cancer patients. Methods: Patients with metastatic or recurrent cervical cancer, who underwent treatment of cadonilimab at Shenzhen People’s Hospital and Huazhong University of Science and Technology Union Shenzhen Hospital. All patients received immunotherapy of cadonilimab at a dose of 10mg/kg of body weight with/without the combination of chemotherapy/bevacizumab/ radiotherapy. Cadonilimab were repeated every 3 weeks until disease progression or intolerable toxicity. Antitumor activity and safety were assessed in all patients. Results: Since July 2022 to November 2023. A total of 18 patients (Figo stage IB1-IIIC) with recurrent/metastatic cervical cancer, 3 patients with newly diagnosed advanced cervical cancer (Figo stage IVB stage) were included. With a median follow-up of 7.0 months (IQR 1.9–15.4), the number of treatment cycles for cadonilimab ranged from 3 to 17 cycles, with a median of 7 cycles. 6 patients with PD-L1-positive expression, 5 patients with negative expression, and 10 patients were unknown. 8 patients combined of chemotherapy, 7 patients received cadonilimab monotherapy, 4 patients combined of chemotherapy and bevacizumab, 1 patient combined of bevacizumab, 1 patients combined of chemotherapy, bevacizumab and radiotherapy . 2 patients with newly diagnosed advanced disease and 2 patients with recurrent cervical cancer achieved complete response (CR), 11 patients with achieved partial response(PR) and 1 patients were in stable disease(SD). The objective response rate (ORR) was 71.4% (15 of 21 patients). The ORR of patients with the PD-L1-negative expression was 80% (4 of 5 patients).Grade 3–4 treatment-related adverse events occurred in 7 (33.3%) of 21 patients, the most frequent grade 3-4 adverse events were decreased white blood cell count (3 14.3%), decreased platelet count (2 9.5%) and anemia (2 9.5%). Immune-related AEs (irAEs) were all G1-2, and occurred in 2 (9.5%) patients. None of the patients discontinued treatment because of intolerable toxicity. Conclusions: In this study, cadonilimab containing therapies showed promising results in responses and survival outcomes among patients with metastatic or recurrent cervical cancer and have a favorable safety profile. Table: see text