Cadonilimab safety and efficacy in recurrent or metastatic cervical cancer: First real-world experience from a Chinese multicenter study.

e17510 Background: Cadonilimab, a bi-specific antibody that simultaneously targets PD-1 and CTLA-4, was approved on 29 June 2022 in China for the treatment of recurrent or metastatic cervical cancer (R/M CC) in patients who have progressed following platinum-based chemotherapy. The COMPASSION-03 trial recently demonstrated promising tumor response rates with cadonilimab in R/M CC patients. This study aims to assess the efficacy and safety of cadonilimab in a real-world clinical setting in China. Methods: This multicenter retrospective study enrolled 102 patients with R/M CC, who received at least one cycle of cadonilimab at seven medical centers from July 2022 to October 2023. Among these, 94 patients were administered 10 mg/kg of cadonilimab once every 3 weeks on day 1, while 8 patients received 6 mg/kg every 2 weeks on day 1. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and the disease control rate (DCR) of the overall patients, as well as toxicity, were evaluated. Results: The study included patients with squamous cell carcinoma (73 patients), adenocarcinoma (20), adenosquamous carcinoma (5), and small cell neuroendocrine carcinoma (4). The median age was 54 years, ranging from 28 to 83. Initially, most patients presented with advanced disease: stage IIIB (8 patients), stage IIIC (24), and stage IV (43). The Eastern Cooperative Oncology Group (ECOG) performance status was 0, 1, 2, and 3 for 150, 12, 6, and 3 patients, respectively. Cadonilimab was administered as first, second, and third line or beyond in 35 (34.3%), 31 (30.4%), and 36 (35.3%) patients, respectively. Treatment regimens included cadonilimab monotherapy (13.7%), combined with chemotherapy (33.3%), chemoradiotherapy (19.6%), anti-angiogenesis therapy (11.8%), chemotherapy and anti-angiogenesis therapy (7.8%), chemoradiotherapy and anti-angiogenesis therapy (10.8%), and surgery plus chemoradiotherapy (2.9%). After a median follow-up of 10.2 months, median PFS and OS were not reached. Among the 93 patients (88.2%) with evaluable efficacy, 8 were CR, 32 were PR, 32 were SD, and 22 were PD. The ORR reached 43.0% and the DCR reached 77.4%. Adverse events were reported by 88.2% of patients, with 31 (30.4%) experiencing grade 3-4 immunotherapy-related adverse effects, mainly decreased white blood cell count(21 patients, 20.6%),, anaemia (6, 5.9%), infection (4, 3.9%), and increased alanine aminotransferase (3, 2.9%). Treatment discontinuation or reduction due to toxicity occurred in 17 patients (16.7%). There were no treatment-related deaths. Conclusions: Cadonilimab demonstrates efficacy and safety for patients with recurrent/metastatic cervical cancer in a real-world setting.