• Xiaohua Wu, Yang Sun, Hongying Yang, Jing Wang, Hanmei Lou, Dan Li, Ke Wang, Hui Zhang, Tao Wu, Yuzhi Li, Chunyan Wang, Guiling Li, Yifeng Wang, Dapeng Li, Ying Tang, Mei Pan, Hongyi Cai, Weihu Wang, Bing Yang, Hua Qian, Qiuhong Tian, Desheng Yao, Ying Cheng, Bing Wei, Xiumin Li, Tao Wang, Min Hao, Xiaohong Wang, Tiejun Wang, Juntao Ran, Hong Zhu, Lijing Zhu, Xianling Liu, Yunxia Li, Lihong Chen, Qingshan Li, Xiaojian Yan, Fei Wang, Hongbing Cai, Yunyan Zhang, Zhiqing Liang, Funan Liu, Yi Huang, Bairong Xia, Pengpeng Qu, Genhai Zhu, Youguo Chen, Kun Song, Meili Sun, Zhengzheng Chen, Qiang Zhou, Lina Hu, Guzhalinuer Abulizi, Hongyan Guo, Sihai Liao, Yijing Ye, Ping Yan, Qiu Tang, Guoping Sun, Ting Liu, Dongmei Lu, Mingxiu Hu, Zhongmin M Wang, Baiyong Li, and Michelle Xia.
• Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. Electronic address: wu.xh@fudan.edu.cn.
• Lancet. 2024 Oct 15.

BackgroundCadonilimab is a bispecific antibody targeting PD-1 and CTLA-4, which has shown substantial clinical benefits in advanced cervical cancer. In the COMPASSION-16 trial, we aimed to evaluate the addition of cadonilimab to first-line standard chemotherapy in persistent, recurrent, or metastatic cervical cancer.MethodsIn this randomised, double-blind, multicentre, placebo-controlled phase 3 trial, women aged 18-75 years across 59 clinical sites in China with previously untreated persistent, recurrent, or metastatic cervical cancer were randomly assigned (1:1) to receive cadonilimab (10 mg/kg) or placebo plus platinum-based chemotherapy with or without bevacizumab every 3 weeks for six cycles, followed by maintenance therapy every 3 weeks for up to 2 years. Randomisation was performed centrally through an interactive web-response system. Stratification factors were the use of bevacizumab (yes or no) and previous concurrent chemoradiotherapy (yes or no). The dual primary outcomes were progression-free survival as assessed by blinded independent central review and overall survival in the full analysis set. This study is registered with ClinicalTrials.gov, NCT04982237; the study has completed enrolment and is ongoing for treatment and follow-up.Findings445 eligible women were enrolled between Sept 11, 2021, and June 23, 2022. Median progression-free survival was 12·7 months (95% CI 11·6-16·1) in the cadonilimab group and 8·1 months (7·7-9·6) in the placebo group (hazard ratio 0·62 [95% CI 0·49-0·80], p<0·0001); median overall survival was not reached (27·0 months to not estimable) versus 22·8 months (17·6-29·0), respectively (hazard ratio 0·64 [0·48-0·86], p=0·0011). The most common grade 3 or higher adverse events were decreased neutrophil count, decreased white blood cell count, and anaemia.InterpretationThe addition of cadonilimab to first-line standard chemotherapy significantly improved progression-free survival and overall survival with a manageable safety profile in participants with persistent, recurrent, or metastatic cervical cancer. The data support the use of cadonilimab plus chemotherapy as an efficacious first-line therapy in persistent, recurrent, or metastatic cervical cancer.FundingAkeso Biopharma.Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

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