BACKGROUND Nivolumab has demonstrated antitumor activity and manageable safety in the single-arm, phase II CheckMate 275 study in patients with unresectable locally advanced or metastatic platinum-resistant urothelial carcinoma. We report updated results of the global population and a subanalysis of Japanese patients from this study. METHODS Patients received nivolumab 3 mg/kg intravenously every 2 weeks until progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) confirmed by blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included progression-free survival (PFS) by BIRC and overall survival (OS). Safety was also reported. The minimum follow-up was 21 months. RESULTS Overall, 270 patients were treated with nivolumab globally; 23 patients were Japanese. In the global and Japanese populations, respectively, ORR per BIRC was 20.4% and 21.7%; median PFS was 1.9 (95% confidence interval [CI] 1.9-2.3) and 3.8 months (95% CI 1.9-7.2); and median OS was 8.6 (95% CI 6.1-11.3) and 21.0 months (95% CI 7.2-not reached). The most common any grade treatment-related adverse events were fatigue (18.1%) and diarrhea (12.2%) in the global population; the most common in the Japanese population were diarrhea (26.1%) and pyrexia (13.0%). Grade 3 or 4 treatment-related adverse events occurred in 61 (22.6%) and seven (30.4%) of the global and Japanese patients, respectively. CONCLUSIONS Nivolumab continues to show antitumor activity and survival in the global population of CheckMate 275. Meaningful clinical benefit was also observed in Japanese patients. No new safety signals were identified.

中文翻译：

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不能切除的局部晚期或转移性尿路上皮癌患者的Nivolumab：CheckMate 275 2年全球和日本患者群体分析。

背景Nivolumab已在单臂II期CheckMate 275研究中针对无法切除的局部晚期或转移性铂耐药尿路上皮癌患者证明了抗肿瘤活性和可控的安全性。我们从这项研究中报告了全球人口的最新结果以及对日本患者的亚分析。方法患者每2周静脉注射3 mg / kg的nivolumab，直至其进展或出现不可接受的毒性。主要终点是盲人独立审查委员会（BIRC）根据“实体瘤反应评估标准v1.1”确定的客观反应率（ORR）。次要终点包括BIRC的无进展生存期（PFS）和总生存期（OS）。还报告了安全性。最小随访时间为21个月。结果总体上，全球共有270例患者接受了nivolumab治疗。日本人23例。在全球和日本人口中，每个BIRC的ORR分别为20.4％和21.7％；PFS中位数为1.9（95％置信区间[CI] 1.9-2.3）和3.8个月（95％CI 1.9-7.2）；OS中位数为8.6（95％CI 6.1-11.3）和21.0个月（95％CI 7.2-未达到）。在全球范围内，最常见的与治疗相关的不良事件为疲劳（18.1％）和腹泻（12.2％）。在日本人口中最常见的是腹泻（26.1％）和发热（13.0％）。在全球和日本患者中，分别有61（22.6％）和7（30.4％）位患者发生了3级或4级与治疗相关的不良事件。结论Nivolumab继续在全球CheckMate 275人群中显示出抗肿瘤活性和存活率。在日本患者中也观察到了有意义的临床益处。