Cadonilimab plus chemotherapy with or without bevacizumab as first-line treatment for advanced cervical cancer: subgroup analyses from the COMPASSION-16 phase 3 trial

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; Chang Liu; 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; Michelle Xia; Xiaohua Wu

doi:10.1038/s41467-026-69965-1

Cadonilimab plus chemotherapy with or without bevacizumab as first-line treatment for advanced cervical cancer: subgroup analyses from the COMPASSION-16 phase 3 trial

Nat Commun. 2026 Mar 14;17(1):3931. doi: 10.1038/s41467-026-69965-1.

Authors

Yang Sun^#¹, Hongying Yang^#², Jing Wang³, Hanmei Lou⁴, Dan Li⁵, Ke Wang⁶, Hui Zhang⁷, Tao Wu⁸, Yuzhi Li⁹, Chunyan Wang¹⁰, Guiling Li¹¹, Yifeng Wang¹², Dapeng Li¹³, Ying Tang¹⁴, Mei Pan¹⁵, Hongyi Cai¹⁶, Weihu Wang¹⁷, Bing Yang¹⁸, Hua Qian¹⁹, Qiuhong Tian²⁰, Desheng Yao²¹, Ying Cheng²², Bing Wei²³, Xiumin Li²⁴, Tao Wang²⁵, Min Hao²⁶, Xiaohong Wang²⁷, Tiejun Wang²⁸, Chang Liu²⁹, Hong Zhu³⁰, Lijing Zhu³¹, Xianling Liu³², Yunxia Li³³, Lihong Chen³⁴, Qingshan Li³⁵, Xiaojian Yan³⁶, Fei Wang³⁷, Hongbing Cai³⁸, Yunyan Zhang³⁹, Zhiqing Liang⁴⁰, Funan Liu⁴¹, Yi Huang⁴², Bairong Xia⁴³, Pengpeng Qu⁴⁴, Genhai Zhu⁴⁵, Youguo Chen⁴⁶, Kun Song⁴⁷, Meili Sun⁴⁸, Zhengzheng Chen⁴⁹, Qiang Zhou⁵⁰, Lina Hu⁵¹, Guzhalinuer Abulizi⁵², Hongyan Guo⁵³, Sihai Liao⁵⁴, Yijing Ye⁵⁵, Ping Yan⁵⁶, Qiu Tang⁵⁷, Guoping Sun⁵⁸, Ting Liu⁵⁹, Dongmei Lu⁵⁹, Mingxiu Hu⁵⁹, Zhongmin M Wang⁵⁹, Baiyong Li⁵⁹, Michelle Xia⁵⁹, Xiaohua Wu⁶⁰

Affiliations

¹ Department of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China.
² Gynecology Department, Yunnan Cancer Hospital, Kunming, China.
³ Gynecologic Oncology Department, Hunan Cancer Hospital, and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
⁴ Gynecologic Radiation Department, Zhejiang Cancer Hospital, Hangzhou, China.
⁵ Oncology Department, The Affiliated Hospital of Southwest Medical University, Luzhou, China.
⁶ Gynecologic Oncology Department, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
⁷ Gynecology Department, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
⁸ Oncology Department, Changde Hospital, Xiangya School of Medicine, Central South University, Changde, China.
⁹ Gynecologic Oncology Department, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
¹⁰ Gynecology Department, Liaoning Cancer Hospital and Institute, Shenyang, China.
¹¹ Gynecologic Oncology Department, Union Hospital Affiliated to Tongji Medical College, Wuhan, China.
¹² Obstetrics and Gynaecology Department, Zhujiang Hospital of Southern Medical University, Guangzhou, China.
¹³ Uterine Tumor Ward I, Cancer Hospital of Shandong First Medical University, Jinan, China.
¹⁴ Gynecologic Oncology Department, Affiliated Cancer Hospital of Chongqing University, Chongqing, China.
¹⁵ Gynecology Department, Jiangxi Maternal and Child Health Hospital, Nanchang, China.
¹⁶ Radiotherapy Department, Gansu Provincial Hospital, Lanzhou, China.
¹⁷ Radiotherapy Department, Beijing Cancer Hospital, Beijing, China.
¹⁸ Gynecology Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.
¹⁹ Gynecology Department, Taizhou People's Hospital Affiliated to Nanjing Medical University, Taizhou, China.
²⁰ Oncology Department, The First Affiliated Hospital of Nanchang University, Nanchang, China.
²¹ Gynecology Department, Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute, Nanning, China.
²² Oncology Department, Jilin Cancer Hospital, Changchun, China.
²³ Obstetrics and Gynecology Department, The Second Hospital of Anhui Medical University, Hefei, China.
²⁴ Gynecology Ward 2, Linyi Cancer Hospital, Linyi, China.
²⁵ Department of Radiotherapy, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
²⁶ Obstetrics and Gynecology Department, Second Hospital of Shanxi Medical University, Taiyuan, China.
²⁷ Department of Radiotherapy, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
²⁸ Department of Radiotherapy, Second Hospital of Jilin University, Changchun, China.
²⁹ Gynecology Department, The First Hospital of Lanzhou University, Lanzhou, China.
³⁰ Oncology Department, Xiangya Hospital Central South University, Changsha, China.
³¹ Oncology Department, Nanjing Drum Tower hospital, Nanjing, China.
³² Oncology Department, The Second Xiangya Hospital, Central South University, Changsha, China.
³³ Medical Oncology Department, General Hospital of Ningxia Medical University, Yinchuan, China.
³⁴ Gynecology Department, Shaanxi Provincial People's Hospital, Xi'an, China.
³⁵ Oncology Department, Affiliated Hospital of Chengde Medical University, Chengde, China.
³⁶ Department of Gynecology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
³⁷ Gynecology Department, Shandong Provincial Hospital, Jinan, China.
³⁸ Gynecologic Oncology Department, Zhongnan Hospital Affiliated to Wuhan University, Wuhan, China.
³⁹ Gynecologic Radiotherapy Department, Affiliated Cancer Hospital of Harbin Medical University, Harbin, China.
⁴⁰ Obstetrics and Gynecology Department, The First Affiliated Hospital of Army Military Medical University, Chongqing, China.
⁴¹ Phase I Clinical Trials Centre, The First Hospital of China Medical University, Shenyang, China.
⁴² Gynecologic Oncology Department, Hubei Cancer Hospital, Wuhan, China.
⁴³ Gynecology Department, Anhui Provincial Cancer Hospital, Hefei, China.
⁴⁴ Gynecologic Oncology Department, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China.
⁴⁵ Gynecology Department, Hainan General Hospital, Haikou, China.
⁴⁶ Gynecology Department, The First Affiliated Hospital of Soochow University, Suzhou, China.
⁴⁷ Gynecology Department, Qilu Hospital of Shandong University, Jinan, China.
⁴⁸ Oncology Department, Jinan Central Hospital, Jinan, China.
⁴⁹ Department of Obstetrics and Gynecology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China.
⁵⁰ Oncology Department, Suining Central Hospital, Suining, China.
⁵¹ Gynecology Department, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
⁵² Gynecology Department, Cancer Hospital Affiliated to Xinjiang Medical University, Urumqi, China.
⁵³ Obstetrics and Gynaecology Department, Peking University Third Hospital, Beijing, China.
⁵⁴ Gynecologic Oncology Department, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.
⁵⁵ Department of Radiation Therapy for Abdominal Tumor, Zhongshan City People's Hospital, Zhongshan, China.
⁵⁶ Gynecology Department, Hebei General Hospital, Shijiazhuang, China.
⁵⁷ Department of Radiation Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
⁵⁸ Oncology Department, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
⁵⁹ Akeso Biopharma Inc., Zhongshan, China.
⁶⁰ Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. wu.xh@fudan.edu.cn.

^# Contributed equally.

Abstract

The phase 3 COMPASSION-16 trial demonstrates significant progression-free survival (PFS) and overall survival (OS) benefits with cadonilimab plus standard therapy in patients with persistent, recurrent, or metastatic cervical cancer. This analysis aims to assess efficacy outcomes in patient subgroups of COMPASSION-16. The dual primary endpoints of COMPASSION-16 are PFS, assessed by the blinded independent central review (BICR) according to RECIST version 1.1, and OS. The secondary endpoint is objective response rate. In this subgroup analysis, the PFS, OS and objective response rate are evaluated in subgroups including bevacizumab use, prior concurrent chemoradiotherapy, PD-L1 combined positive score (CPS), metastatic disease at baseline, platinum use, and age. With median follow-up of 25.6 months, hazard ratios (HRs) for PFS favour cadonilimab group in all subgroups. Moreover, the addition of cadonilimab is also associated with prolonged overall survival. This subgroup analysis confirms that improvements in progression-free and overall survival are consistent with the primary results of the COMPASSION-16 study across diverse patient profiles.

Publication types

Clinical Trial, Phase III
Randomized Controlled Trial
Multicenter Study

MeSH terms

Adult
Aged
Antibodies, Monoclonal, Humanized* / administration & dosage
Antibodies, Monoclonal, Humanized* / therapeutic use
Antineoplastic Combined Chemotherapy Protocols* / adverse effects
Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
Bevacizumab* / administration & dosage
Bevacizumab* / therapeutic use
Female
Humans
Middle Aged
Progression-Free Survival
Treatment Outcome
Uterine Cervical Neoplasms* / drug therapy
Uterine Cervical Neoplasms* / mortality
Uterine Cervical Neoplasms* / pathology

Substances

Bevacizumab
Antibodies, Monoclonal, Humanized