Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with refractory/metastatic nasopharyngeal carcinoma: Interim results of an open-label phase II clinical study.

作者：Feng‐Hua Wang, Xiaoli Wei, J. Feng, Qi Li, Nong Xu, Xichun Hu, Yi Jiang, Wangjun Liao, Qingyuan Zhang, Xianglin Yuan, Haixin Huang, Ye Chen, Guanghai Dai, Jianhua Shi, Lin Shen, Shujun Yang, Yongqian Shu, Yunpeng Liu, Rui‐Hua Xu · 发表于：Journal of Clinical Oncology · 年份：2019 · DOI：10.1200/jco.2019.37.15_suppl.6017 · 被引用次数：8 · 研究领域：Cancer Immunotherapy and Biomarkers、CAR-T cell therapy research、Cancer Cells and Metastasis

6017 Background: Metastatic nasopharyngeal cancer (NPC) patients progressed afterstandardtherapy have limited treatment options. Toripalimab, also known as JS001, a humanized IgG4 antibody specific for human PD-1, has been approved for 2 nd line treatment of metastatic melanoma in China. Here we report the results from a phase IIstudy in metastatic NPC patients treated with toripalimab.(Clinical trial ID: NCT02915432). Methods: This multi-center, open-label, phase II registration study is designed to evaluate the safety and efficacy of toripalimab in metastaticNPC patients who have failed systemic treatment. Toripalimabis given at 3 mg/kg IV Q2W until disease progression or intolerable toxicity.Tumor PD-L1 expression, plasma EBV DNA level and other biomarkerswill be correlatedwith clinical response. Results: Enrollment of 190chemo-refractory metastatic NPCpatients was completed by Feb 2019 from 17 participating centers. The median age was 46 years, with 89.5% patients received at least 2 lines of prior systemic therapies. Treatment related adverse events (TRAE)occurred in 92% patients, which were mostly grade 1 or 2.Common TRAE includedanemia, hypothyroidism, AST increased, proteinuria, pyrexia, cough, constipation, ALT increased, hypoalbuminemia and pruritus.Grade 3 or higherTRAEoccurred in 25% patients.By the cut-off date of Jan 7 2019, among 135 evaluable patients, 3 complete responses, 31 partial responses and 40 stable diseaseswere observed for an objective response rate...