Camrelizumab Plus Famitinib versus Camrelizumab Alone and Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer: A Randomized, Phase II Study
Abstract
PURPOSE To compare camrelizumab (an anti-PD-1 monoclonal antibody) plus famitinib (a multitarget receptor tyrosine kinase inhibitor) versus camrelizumab and chemotherapy in recurrent or metastatic cervical cancer (R/M CC). METHODS Patients with pretreated R/M CC were randomly assigned to receive camrelizumab (200 mg intravenously once every 3 weeks) plus famitinib (20 mg orally once daily), camrelizumab, or investigator's choice of chemotherapy. The primary end point was comparison of objective response rate (ORR) per blinded independent central review (BICR) for camrelizumab-famitinib versus camrelizumab in the intention-to-treat population. RESULTS Overall, 105, 54, and 35 patients received camrelizumab-famitinib, camrelizumab, and chemotherapy, respectively. As of April 21, 2023, ORR per BICR was significantly improved with camrelizumab-famitinib compared with camrelizumab (41.0% [95% CI, 31.5 to 51.0] v 24.1% [95% CI, 13.5 to 37.6]; difference, 16.9% [95% CI, 2.1 to 31.7]; one-sided P = .0181). Per investigator, ORR with camrelizumab-famitinib was 42.9% (95% CI, 33.2 to 52.9), notably higher than 22.2% (95% CI, 12.0 to 35.6) with camrelizumab and 14.3% (95% CI, 4.8 to 30.3) with chemotherapy. Median progression-free survival per investigator was prolonged with camrelizumab-famitinib than camrelizumab and chemotherapy (8.1 months [95% CI, 6.2 to 12.4] vs 4.1 months [95% CI, 2.1 to 5.1] and 2.9 months [95% CI, 2.0 to 6.2]). Median overall survival with camrelizumab-famitinib, camrelizumab, and chemotherapy, as of October 19, 2023, was 20.2 months (95% CI, 15.3 to not reached [NR]), 14.9 months (95% CI, 12.6 to NR), and 13.9 months (95% CI, 7.4 to 20.0), respectively. Eighty-nine (84.8%), eight (15.1%), and 18 (60.0%) patients who received camrelizumab-famitinib, camrelizumab, and chemotherapy, respectively, experienced grade ≥3 treatment-related adverse events. CONCLUSION Camrelizumab plus famitinib improved antitumor activity while exhibiting a manageable safety profile in patients with pretreated R/M CC, potentially offering a novel treatment option.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (37)
Lingfang Xia
Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
Keqiang Zhang
Hunan Cancer Hospital, Changsha, China
Ying Tang
Guonan Zhang
Sichuan Cancer Hospital Chengdu China
Danbo Wang
Cancer Hospital of China Medical University Liaoning Cancer Hospital and Institute Shenyang China
Hanmei Lou
Naifu Liu
Department of Gynecology Oncology, Shandong Cancer Hospital & Institute, Jinan, China
Hongping Zhang
Hongwei Chen
State Key Laboratory of Coordination Chemistry, Chemistry and Biomedicine Innovation Center (ChemBIC), ChemBioMed Interdisciplinary Research Center at Nanjing University, School of Chemistry
Ke Wang
Tianjin Medical University Cancer Institute and Hospital Tianjin China
Shuqing Wei
Shanxi Cancer Hospital Taiyuan China
Li Wang
The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital Zhengzhou China
Kun Gao
Guiling Li
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan China
Huifeng Zhang
Yuanjing Hu
Tianjin Central Hospital of Obstetrics and Gynecology Tianjin China
Weidong Zhao
Yunyan Zhang
Hong Zhu
School of Life and Health Technology
An Lin
Fujian Provincial Cancer Hospital Fuzhou China
Jinwei Miao
Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China
Guohua Yu
Keqin Hua
Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
Liangdan Tang
Ziling Liu
First Hospital of Jilin University, Changchun, China
Bingzhong Zhang
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Hongwei Li
Peking University , , ,
Min Zheng
School of Chemical Engineering
Xiaohong Wang
Department of Ophthalmology, Tianjin Medical University General Hospital, International Joint Laboratory of Ocular Diseases (Ministry of Education), State Key Laboratory of Experimental Hematology, Tianjin Key Laboratory of Ocular Trauma, Laboratory of Molecular Ophthalmology, Tianjin Medical University
Fenghu Li
Department of Gynecology Oncology, The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China
Xinfeng Yang
Jiangxi Cancer Hospital Nanchang China
Huaijun Zhou
Nanjing Drum Tower Hospital Nanjing China
Bairong Xia
Anhui Provincial Cancer Hospital Hefei China
Xianfeng Zhou
College of Polymer Science and Engineering Qingdao University of Science and Technology Qingdao P.R. China
Yuting Wang
Dalian Institute of Chemical Physics, Chinese Academy of Sciences
Quanren Wang
Jiangsu Hengrui Pharmaceuticals Shanghai China
Xiaohua Wu
Fudan University Shanghai Cancer Center Shanghai China