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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)

Author

Listed:
  • 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.)

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

Suggested Citation

  • 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, 2022. "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," Nature Communications, Nature, vol. 13(1), pages 1-12, December.
    • Handle: RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-022-28408-3
    DOI: 10.1038/s41467-022-28408-3
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