Dana-Farber Cancer Institute, Department of Genitourinary Oncology, 450 Brookline Ave. Boston, MA 02215, USA.
IMIM-Hospital del Mar Medical Research Institute, Department of Genitourinary Oncology, Doctor Aiguader, 88, 1st Floor, 08003 Barcelona, Spain.
Future Oncol. 2017 Dec;13(30):2745-2758. doi: 10.2217/fon-2017-0284. Epub 2017 Sep 12.
Pembrolizumab is a humanized monoclonal antibody that targets PD-1. In the Phase III trial KEYNOTE-045, pembrolizumab was associated with a significant overall survival benefit when compared with docetaxel, paclitaxel and vinflunine in second line metastatic urothelial carcinoma (UC). Additionally, in the first line, early results from an interim analysis of the Phase II trial Keynote-052 study indicated that pembrolizumab is efficacious for cisplatin-ineligible patients. Based on data from these trials, pembrolizumab was the most recent among the five checkpoint inhibitors tested in UC to be approved by the US FDA in May 2017. It was granted regular approval for patients with advanced-stage UC who progress after receiving platinum-based chemotherapy and accelerated approval in the first line for patients who are ineligible to receive cisplatin.
帕博利珠单抗是一种针对 PD-1 的人源化单克隆抗体。在 III 期 KEYNOTE-045 试验中，与多西他赛、紫杉醇和长春氟宁相比，帕博利珠单抗在二线转移性尿路上皮癌（UC）中具有显著的总生存获益。此外，在一线，来自 II 期试验 Keynote-052 的中期分析的初步结果表明，帕博利珠单抗对顺铂不耐受的患者有效。基于这些试验的数据，帕博利珠单抗是 2017 年 5 月美国食品和药物管理局（FDA）批准的五种在 UC 中测试的检查点抑制剂中最新的一种。它被批准用于铂类化疗后进展的晚期 UC 患者，对于不符合顺铂治疗条件的患者，它被加速批准用于一线治疗。
