Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial

Zi-Xian Wang; Chengxu Cui; Jun Yao; Yanqiao Zhang; Mengxia Li; Jifeng Feng; Shujun Yang; Yun Fan; Jianhua Shi; Xizhi Zhang; Lin Shen; Yongqian Shu; Cailian Wang; Tianyang Dai; Teng Mao; Long Chen; Zengqing Guo; Bo Liu; Hongming Pan; Shundong Cang; Yi Jiang; Junye Wang; Min Ye; Zhendong Chen; Da Jiang; Qin Lin; Wei Ren; Junsheng Wang; Lin Wu; Yong Xu; Zhanhui Miao; Meili Sun; Conghua Xie; Ying Liu; Qifeng Wang; Lina Zhao; Qi Li; Canhong Huang; Ke Jiang; Kunyu Yang; Daojun Li; Yunpeng Liu; Zhitu Zhu; Rixin Chen; Liqun Jia; Wei Li; Wangjun Liao; Hong-Xu Liu; Daiyuan Ma; Jie Ma; Yanru Qin; Zhihong Shi; Qichun Wei; Ke Xiao; Yan Zhang; Ying Zhang; Xin Chen; Guanghai Dai; Jianxing He; Junhe Li; Guanghui Li; Yong Liu; Zhihua Liu; Xianglin Yuan; Junping Zhang; Zhichao Fu; Yifu He; Fang Ju; Zheng Liu; Peng Tang; Tiejun Wang; Weibo Wang; Jing Zhang; Xianming Luo; Xiongwen Tang; Rena May; Hui Feng; Sheng Yao; Patricia Keegan; Rui-Hua Xu; Feng Wang

doi:10.1016/j.ccell.2022.02.007

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Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial

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Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial

Zi-Xian Wang, Chengxu Cui, Jun Yao, Yanqiao Zhang, Mengxia Li, Jifeng Feng, Shujun Yang, Yun Fan, Jianhua Shi, Xizhi Zhang, …

Cancer cell, Vol.40(3), pp.277-288.e3

14/03/2022

DOI: https://doi.org/10.1016/j.ccell.2022.02.007

PMID: 35245446

Abstract

advanced esophageal squamous cell carcinoma

double-blind

immunotherapy

multi-center

paclitaxel plus cisplatin

PD-1 inhibitor

randomized study

Platinum-based chemotherapy is the standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). In this phase 3 study (ClinicalTrial.gov: NCT03829969), 514 patients with treatment-naïve advanced ESCC were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin (TP) every 3 weeks for up to 6 cycles, followed by toripalimab or placebo maintenance. At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS is observed for the toripalimab arm over the placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46–0.74; p < 0.0001). The prespecified interim analysis of overall survival (OS) also reveals a significant OS improvement for patients treated with toripalimab plus TP over placebo plus TP (HR = 0.58; 95% CI, 0.43–0.78; p = 0.0004). The incidences of grade ≥3 treatment-emergent adverse events are similar between the two arms. Toripalimab plus TP significantly improves PFS and OS in patients with treatment-naïve, advanced ESCC, with a manageable safety profile. [Display omitted] •First-line toripalimab plus chemotherapy for esophageal squamous cell carcinoma•Toripalimab plus chemotherapy improves progression-free survival and overall survival•Toripalimab plus chemotherapy is efficacious irrespective of PD-L1 expression•Toripalimab plus chemotherapy shows a manageable safety profile Wang et al. demonstrate the efficacy and safety of toripalimab plus paclitaxel/cisplatin as the first-line treatment for patients with advanced esophageal squamous cell carcinoma. As compared with paclitaxel/cisplatin alone, toripalimab plus paclitaxel/cisplatin extends progression-free survival and overall survival of the patients irrespective of PD-L1 expression.

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Title: Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial
Creators - without role: Zi-Xian Wang - Sun Yat-sen University Cancer Center
Chengxu Cui - Cancer Hospital of Chinese Academy of Medical Sciences
Jun Yao - First Affiliated Hospital of Henan University of Science and Technology
Yanqiao Zhang - Third Affiliated Hospital of Harbin Medical University
Mengxia Li - Army Medical Center of PLA, Chongqing 400042, China
Jifeng Feng - Jiangsu Cancer Hospital
Shujun Yang - Henan Cancer Hospital
Yun Fan - Zhejiang Cancer Hospital
Jianhua Shi - Linyi People's Hospital
Xizhi Zhang - Northern Jiangsu People's Hospital
Lin Shen - Peking University Cancer Hospital
Yongqian Shu - Jiangsu Province Hospital
Cailian Wang - Zhongda Hospital Southeast University
Tianyang Dai - Affiliated Hospital of Southwest Medical University
Teng Mao - Shanghai Chest Hospital
Long Chen - Tumor Hospital of Guangxi Medical University
Zengqing Guo - Fujian Provincial Cancer Hospital
Bo Liu - Shandong Tumor Hospital
Hongming Pan - Sir Run Run Shaw Hospital
Shundong Cang - Henan Provincial People's Hospital
Yi Jiang - Cancer Hospital of Shantou University Medical College
Junye Wang - Zhongda Hospital Southeast University
Min Ye - Jiangmen Central Hospital
Zhendong Chen - Tumor Hospital of Guangxi Medical University
Da Jiang - Affiliated Hospital of Southwest Medical University
Qin Lin - Peking University Cancer Hospital
Wei Ren - Nanjing Drum Tower Hospital
Junsheng Wang - Anyang Cancer Hospital, Anyang 455000, China
Lin Wu - Peking University Cancer Hospital
Yong Xu - Cancer Hospital of Chinese Academy of Medical Sciences
Zhanhui Miao - First Affiliated Hospital of Xinxiang Medical University
Meili Sun - Jinan Central Hospital
Conghua Xie - Zhongnan Hospital of Wuhan University
Ying Liu - Shandong Tumor Hospital
Qifeng Wang - Zhongda Hospital Southeast University
Lina Zhao - Xijing Hospital
Qi Li - Shandong Tumor Hospital
Canhong Huang - Nantong Tumor Hospital
Ke Jiang - Huazhong University of Science and Technology
Kunyu Yang - Affiliated Hospital of Southwest Medical University
Daojun Li - Shandong Tumor Hospital
Yunpeng Liu - The First Hospital of China Medical University, Shenyang 110000, China
Zhitu Zhu - The First Affiliated Hospital of Jinzhou Medical University, Jinzhou 121000, China
Rixin Chen - Tumor Hospital of Guangxi Medical University
Liqun Jia - Linyi People's Hospital
Wei Li - Shandong Tumor Hospital
Wangjun Liao - Nanfang Hospital Southern Medical University, Guangzhou 510000, China
Hong-Xu Liu - Liaoning Cancer Hospital & Institute
Daiyuan Ma - Affiliated Hospital of North Sichuan Medical College
Jie Ma - First Affiliated Hospital of GuangXi Medical University
Yanru Qin - Fujian Provincial Cancer Hospital
Zhihong Shi - Linyi People's Hospital
Qichun Wei - Second Affiliated Hospital of Zhejiang University
Ke Xiao - Second Affiliated Hospital of Shantou University Medical College
Yan Zhang - Third Affiliated Hospital of Harbin Medical University
Ying Zhang - Northern Jiangsu People's Hospital
Xin Chen - Tumor Hospital of Guangxi Medical University
Guanghai Dai - Affiliated Hospital of Southwest Medical University
Jianxing He - Tumor Hospital of Guangxi Medical University
Junhe Li - First Affiliated Hospital of Nanchang University
Guanghui Li - Shandong Tumor Hospital
Yong Liu - Shandong Tumor Hospital
Zhihua Liu - Shandong Tumor Hospital
Xianglin Yuan - Tongji Hospital
Junping Zhang - Northern Jiangsu People's Hospital
Zhichao Fu - Chinese People's Liberation Army
Yifu He - Anhui Provincial Cancer Hospital, Hefei 230000, China
Fang Ju - Qingdao Central Hospital, Qingdao 266000, China
Zheng Liu - HanDan Central Hospital, Handan 056000, China
Peng Tang - Tianjin Medical University
Tiejun Wang - Jilin University
Weibo Wang - Zhongda Hospital Southeast University
Jing Zhang - Northern Jiangsu People's Hospital
Xianming Luo - Shanghai Junshi Biosciences, Shanghai 200126, China
Xiongwen Tang - Shanghai Junshi Biosciences, Shanghai 200126, China
Rena May - TopAlliance Biosciences, Rockville, MD 20850, USA
Hui Feng - Jiangsu Cancer Hospital
Sheng Yao - First Affiliated Hospital of Henan University of Science and Technology
Patricia Keegan - TopAlliance Biosciences, Rockville, MD 20850, USA
Rui-Hua Xu - Cancer Hospital of Chinese Academy of Medical Sciences
Feng Wang - Zhongda Hospital Southeast University
Publication Details: Cancer cell, Vol.40(3), pp.277-288.e3
Publisher: Elsevier Inc
Identifiers: 9944589408331
Academic Unit: King Abdullah University of Science & Technology
Language: English
Resource Type: Journal article