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

• Published in: Cancer cell Vol. 40; no. 3; pp. 277 - 288.e3
• Main Authors: Wang, Zi-Xian, Cui, Chengxu, Yao, Jun, Zhang, Yanqiao, Li, Mengxia, Feng, Jifeng, Yang, Shujun, Fan, Yun, Shi, Jianhua, Zhang, Xizhi, Shen, Lin, Shu, Yongqian, Wang, Cailian, Dai, Tianyang, Mao, Teng, Chen, Long, Guo, Zengqing, Liu, Bo, Pan, Hongming, Cang, Shundong, Jiang, Yi, Wang, Junye, Ye, Min, Chen, Zhendong, Jiang, Da, Lin, Qin, Ren, Wei, Wang, Junsheng, Wu, Lin, Xu, Yong, Miao, Zhanhui, Sun, Meili, Xie, Conghua, Liu, Ying, Wang, Qifeng, Zhao, Lina, Li, Qi, Huang, Canhong, Jiang, Ke, Yang, Kunyu, Li, Daojun, Liu, Yunpeng, Zhu, Zhitu, Chen, Rixin, Jia, Liqun, Li, Wei, Liao, Wangjun, Liu, Hong-Xu, Ma, Daiyuan, Ma, Jie, Qin, Yanru, Shi, Zhihong, Wei, Qichun, Xiao, Ke, Zhang, Yan, Zhang, Ying, Chen, Xin, Dai, Guanghai, He, Jianxing, Li, Junhe, Li, Guanghui, Liu, Yong, Liu, Zhihua, Yuan, Xianglin, Zhang, Junping, Fu, Zhichao, He, Yifu, Ju, Fang, Liu, Zheng, Tang, Peng, Wang, Tiejun, Wang, Weibo, Zhang, Jing, Luo, Xianming, Tang, Xiongwen, May, Rena, Feng, Hui, Yao, Sheng, Keegan, Patricia, Xu, Rui-Hua, Wang, Feng
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 14.03.2022
• Subjects: advanced esophageal squamous cell carcinoma; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols - adverse effects; double-blind; Esophageal Neoplasms - drug therapy; Esophageal Squamous Cell Carcinoma - drug therapy; Humans; immunotherapy; multi-center; paclitaxel plus cisplatin; PD-1 inhibitor; Progression-Free Survival; randomized study; advanced esophageal squamous cell carcinoma; multi-center; immunotherapy; PD-1 inhibitor; double-blind; randomized study; paclitaxel plus cisplatin
• ISSN: 1535-6108; 1878-3686; 1878-3686
• DOI: 10.1016/j.ccell.2022.02.007

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.