Clinical and biomarker analyses of sintilimab versus chemotherapy as second-line therapy for advanced or metastatic esophageal squamous cell carcinoma: a randomized, open-label phase 2 study (ORIENT-2)

Jianming Xu (), Yi Li, Qingxia Fan, Yongqian Shu, Lei Yang, Tongjian Cui, Kangsheng Gu, Min Tao, Xiuwen Wang, Chengxu Cui, Nong Xu, Juxiang Xiao, Quanli Gao, Yunpeng Liu, Tao Zhang, Yuxian Bai, Wei Li, Yiping Zhang, Guanghai Dai, Dong Ma, Jingdong Zhang, Chunmei Bai, Yunchao Huang, Wangjun Liao, Lin Wu, Xi Chen, Yan Yang, Junye Wang, Shoujian Ji, Hui Zhou, Yan Wang, Zhuo Ma, Yanqi Wang, Bo Peng, Jiya Sun and Christoph Mancao
Additional contact information
Jianming Xu: Chinese PLA General Hospital
Yi Li: Chinese PLA General Hospital
Qingxia Fan: The First Affiliated Hospital of Zhengzhou University
Yongqian Shu: The First Affiliated Hospital of Nanjing Medical University
Lei Yang: Nantong Tumor Hospital
Tongjian Cui: Fujian Provincial Hospital
Kangsheng Gu: The First Affiliated Hospital of Anhui Medical University
Min Tao: The First Affiliated Hospital of Soochow University
Xiuwen Wang: Qilu Hospital of Shandong University
Chengxu Cui: Chinese Academy of Medical Sciences and Peking Union Medical College
Nong Xu: The First Affiliated Hospital of Zhejiang University
Juxiang Xiao: The First Affiliated Hospital of Xi’an Jiaotong University
Quanli Gao: Henan Cancer Hospital
Yunpeng Liu: The First Hospital of China Medical University
Tao Zhang: Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Yuxian Bai: Harbin Medical University Cancer Hospital
Wei Li: The First Hospital of Jilin University
Yiping Zhang: Zhejiang Cancer Hospital
Guanghai Dai: Chinese People’s Liberation Army General Hospital
Dong Ma: Guangdong Provincial People’s Hospital
Jingdong Zhang: Liaoning Cancer Hospital
Chunmei Bai: Chinese Academy of Medical Sciences
Yunchao Huang: Yunnan Cancer Hospital
Wangjun Liao: Southern Medical University
Lin Wu: Hunan Cancer Hospital
Xi Chen: No. 900 Hospital of The Joint Logistic Support Force
Yan Yang: Gansu Provincial Cancer Hospital
Junye Wang: Affiliated Hospital of Jining Medical University
Shoujian Ji: Chinese PLA General Hospital
Hui Zhou: Innovent Biologics, Inc.
Yan Wang: Innovent Biologics, Inc.
Zhuo Ma: Innovent Biologics, Inc.
Yanqi Wang: Innovent Biologics, Inc.
Bo Peng: Innovent Biologics, Inc.
Jiya Sun: Innovent Biologics, Inc.
Christoph Mancao: Innovent Biologics, Inc.

Nature Communications, 2022, vol. 13, issue 1, 1-12

Abstract: Abstract This randomized, open-label, multi-center phase 2 study (NCT03116152) assessed sintilimab, a PD-1 inhibitor, versus chemotherapy in patients with esophageal squamous cell carcinoma after first-line chemotherapy. The primary endpoint was overall survival (OS), while exploratory endpoint was the association of biomarkers with efficacy. The median OS in the sintilimab group was significantly improved compared with the chemotherapy group (median OS 7.2 vs.6.2 months; P = 0.032; HR = 0.70; 95% CI, 0.50–0.97). Incidence of treatment-related adverse events of grade 3–5 was lower with sintilimab than with chemotherapy (20.2 vs. 39.1%). Patients with high T-cell receptor (TCR) clonality and low molecular tumor burden index (mTBI) showed the longest median OS (15.0 months). Patients with NLR

Date: 2022
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DOI: 10.1038/s41467-022-28408-3

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