The Royal Marsden NHS Foundation Trust, Sutton, Surrey SM2 5PT, UK.
The University of Texas MD Anderson Cancer Center, Department of Genitourinary Medical Oncology, Houston, TX 77030, USA.
Future Oncol. 2021 Jan;17(2):137-149. doi: 10.2217/fon-2020-0795. Epub 2020 Sep 17.
The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1) status. For patients with mUC who are ineligible for cisplatin and with low PD-L1 expression, chemotherapy-based regimens are the only approved first-line option. In a Phase I/II trial of the chemotherapy-free regimen, bempegaldesleukin (BEMPEG; NKTR-214) plus nivolumab, patients with locally advanced or mUC experienced tumor responses regardless of baseline PD-L1 expression (objective response rates: 50 and 45% in patients with PD-L1-positive and -negative tumors, respectively). The Phase II PIVOT-10 study (NCT03785925), evaluates efficacy and safety of first-line BEMPEG plus nivolumab in cisplatin-ineligible patients with locally advanced or mUC. Most patients will have low PD-L1 expression. Primary end point: objective response rates (including complete response).
转移性尿路上皮癌 (mUC) 患者的一线治疗选择基于顺铂适用性和程序性死亡配体 1 (PD-L1) 状态。对于不适合顺铂且 PD-L1 表达水平低的 mUC 患者，基于化疗的方案是唯一批准的一线选择。在一项无化疗方案的 I/II 期试验中，bempegaldesleukin（BEMPEG；NKTR-214）联合nivolumab，局部晚期或 mUC 患者无论基线 PD-L1 表达如何都有肿瘤反应（客观缓解率：PD-L1 阳性和阴性肿瘤患者分别为 50%和 45%）。II 期 PIVOT-10 研究（NCT03785925）评估了 BEMPEG 联合 nivolumab 在不适合顺铂的局部晚期或 mUC 患者中的疗效和安全性。大多数患者的 PD-L1 表达水平较低。主要终点：客观缓解率（包括完全缓解）。
