作者
Christophe Massard, Michael S Gordon, Sunil Sharma, Saeed Rafii, Zev A Wainberg, Jason Luke, Tyler J Curiel, Gerardo Colon-Otero, Omid Hamid, Rachel E Sanborn, Peter H O’Donnell, Alexandra Drakaki, Winston Tan, John F Kurland, Marlon C Rebelatto, Xiaoping Jin, John A Blake-Haskins, Ashok Gupta, Neil H Segal
发表日期
2016/9/10
期刊
Journal of Clinical Oncology
卷号
34
期号
26
页码范围
3119-3125
出版商
American Society of Clinical Oncology
简介
Purpose
To investigate the safety and efficacy of durvalumab, a human monoclonal antibody that binds programmed cell death ligand-1 (PD-L1), and the role of PD-L1 expression on clinical response in patients with advanced urothelial bladder cancer (UBC).
Methods
A phase 1/2 multicenter, open-label study is being conducted in patients with inoperable or metastatic solid tumors. We report here the results from the UBC expansion cohort. Durvalumab (MEDI4736, 10 mg/kg every 2 weeks) was administered intravenously for up to 12 months. The primary end point was safety, and objective response rate (ORR, confirmed) was a key secondary end point. An exploratory analysis of pretreatment tumor biopsies led to defining PD-L1–positive as ≥ 25% of tumor cells or tumor-infiltrating immune cells expressing membrane PD-L1.
Results
A total of 61 patients (40 PD-L1–positive, 21 PD-L1–negative), 93.4% of whom …
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C Massard, MS Gordon, S Sharma, S Rafii… - Journal of Clinical Oncology, 2016