PD-1抑制剂信迪利单抗的临床研究进展  

The clinical research progress of PD-1 inhibitor:sintilimab

作　　者：朱丹[1] 李月阳[1] 宋燕青[1] 李艳娇[1] ZHU Dan;LI Yue-yang;SONG Yan-qing;LI Yan-jiao(Department of Pharmacy,the First Hospital of Jilin University,Jilin Changchun 130021,China)

机构地区：[1]吉林大学第一医院药学部

出　　处：《中国医院药学杂志》2020年第1期120-123,共4页Chinese Journal of Hospital Pharmacy

摘　　要：信迪利单抗(商品名:达伯舒■)是一种全人源化IgG4单克隆抗体,可与程序性细胞死亡受体-1(PD-1)结合,从而阻断PD-1与其配体(PD-L1和PL-L2)相互作用,从而有助于恢复内源性抗肿瘤T细胞反应。信迪利单抗由信达生物制药和礼来制药共同合作研发,已在我国批准用于至少经过二线系统化疗的复发或难治性经典型霍奇金淋巴瘤的治疗。目前正在我国进行多项Ⅰ期、Ⅱ期和Ⅲ期临床试验,开发用于多种实体肿瘤的治疗,包括非小细胞肺癌和食道癌。该药用于治疗实体瘤的Ⅰ/Ⅱ期临床试验也正在美国进行,美国FDA已于2018年1月接受信迪利单抗的研究性新药申请。本文对该药的作用机制、药动学和临床研究等进行总结,为更好地指导临床应用提供建议。Sintilimab(Tyvyt■) is a fully humanized IgG4 monoclonal antibody that binds to programmed cell death receptor-1(PD-1), thereby blocking the interaction of PD-1 with its ligands(PD-L1 and PL-L2) and consequently helping to restore the endogenous antitumour T-cell response. It has been co-developed by Innovent Biologics and Eli Lilly and Company, and has been approved in China for the treatment of relapsed or refractory classical Hodgkin lymphoma after at least second-line systemic chemotherapy.A number of phase Ⅰ,Ⅱ, and Ⅲ clinical trials are currently being conducted in China to develop treatments for a variety of solid tumors, including non-small cell lung cancer and esophageal cancer. Phase Ⅰ/Ⅱ clinical trials of the drug for the treatment of solid tumors are also ongoing in the United States, and the US FDA has accepted an investigational new drug application for cindilizumab in January 2018. This article summarizes the mechanism of action, pharmacokinetics and clinical studies of the drug to provide recommendations for better guidance of clinical application.

关 键 词：信迪利单抗 PD-1抑制剂 经典型霍奇金淋巴瘤 肿瘤 

分 类 号：R927[医药卫生—药学]