Recombinant humanized anti-PD-1 monoclonal antibody (JS001) as salvage treatment for advanced esophageal squamous cell carcinoma: Preliminary results of an open-label, multi-cohort, phase Ib/II clinical study.

作者：Rui‐Hua Xu, Feng‐Hua Wang, Jianhua Shi, J. Feng, Lin Shen, Shujun Yang, Xichun Hu, Guanghai Dai, Nong Xu, Yi Jiang, Shu Yongqian, Qingyuan Zhang, Ye Chen, Xianglin Yuan, Xiaoyan Lin, Yi Ba, Qi Li, Wei Li, Haixin Huang, Sheng Yao · 发表于：Journal of Clinical Oncology · 年份：2018 · DOI：10.1200/jco.2018.36.4_suppl.116 · 被引用次数：15 · 研究领域：Esophageal Cancer Research and Treatment、Cancer Immunotherapy and Biomarkers、CAR-T cell therapy research

116 Background: Patients with Esophageal squamous cell carcinoma (EC) often present with advanced and metastatic stage disease, which has poor prognosis and limited treatment options, and represent an important unmet medical need especially in China/Asia. JS001, a humanized recombinant IgG4 antibody against PD-1, selectively blocks the interactions of PD-1 with its ligands PD-L1 and PD-L2, and promotes antigen specific T-cell activation. A phase I study of JS001 in Chinese patients with heavily pretreated solid tumors has demonstrated an acceptable safety profile in doses up to 10 mg/kg Q2W. Here we report the safety and efficacy of JS001 in a phase Ib/II clinical study in Chinese patients with refractory/metastatic EC. (Clinical trial ID: NCT02915432) Methods: Refractory/metastatic EC Patients receive JS001 3 mg/kg Q2W until disease progression or unacceptable toxicity. All patients with measurable disease will be assessed for clinical response every 8 weeks according to the RECIST 1.1 criteria. Tumor PD-L1 expression as well as additional potential predictive biomarkers are monitored for correlation with clinical response. Results: Between Apr 19 2017 and Sep 11 2017, 56 EC pts (84.9% received at least 2 Lines of treatment) were enrolled into the study. Treatment related adverse events occurred were mostly grade 1 or 2. As of Sep 11 2017, 34 EC pts have been evaluated for clinical efficacy. Among these pts, 8 PR (partial response) and 14 SD (stable disease) were observed (O...