Safety, Efficacy, and Biomarker Analysis of Toripalimab in Patients with Previously Treated Advanced Urothelial Carcinoma: Results from a Multicenter Phase II Trial POLARIS-03

医学 内科学 多中心研究 生物标志物 肿瘤科 临床试验 尿路上皮癌 临床研究阶段 泌尿科 癌症 膀胱癌 随机对照试验 生物 生物化学
作者
Xinan Sheng,Haige Chen,Bin Hu,Xudong Yao,Ziling Liu,Xin Yao,Hongqian Guo,Yi Hu,Zhigang Ji,Hong Luo,Benkang Shi,Jiyan Liu,Jin Wu,Fangjian Zhou,Zhisong He,Jinhai Fan,Weifeng Wang,Hui Feng,Sheng Yao,Patricia Keegan
出处
期刊:Clinical Cancer Research [American Association for Cancer Research]
卷期号:28 (3): 489-497 被引量:54
标识
DOI:10.1158/1078-0432.ccr-21-2210
摘要

Abstract Purpose: Immunotherapy offers a second-line option for patients with metastatic urothelial carcinoma (mUC) who failed standard therapy, but the biomarkers for predicting response remain to be explored. This study aims to evaluate the safety, efficacy, and correlative biomarker of toripalimab in patients with previously treated mUC. Patients and Methods: Patients with mUC received toripalimab 3 mg/kg Q2W. Clinical response was assessed every 8 weeks by an independent review committee per RECIST v1.1. Tumor PD-L1 expression, tumor mutational burden (TMB), and other biomarkers were evaluated. Results: Among the intention-to-treat population (n = 151), 85% of the patients experienced treatment-related adverse event (TRAE) and 20% experienced grade 3 and above TRAE. The objective response rate (ORR) was 26% with a disease control rate (DCR) of 45%. The median duration of response, progression-free survival (PFS), and overall survival (OS) were 19.7 months [95% confidence interval (CI): 13.9–not estimable], 2.3 months (95% CI, 1.8–3.6), and 14.4 months (95% CI, 9.3–23.1), respectively. Both PD-L1+ and TMB-high (10 mutations/Mb as the cutoff) patients had better ORR than PD-L1− patients (42% vs. 17%, P = 0.002) and TMB-low patients (48% vs. 22%, P = 0.014), respectively. The TMB-high group also showed better PFS (12.9 vs. 1.8 months, P < 0.001) and OS (not reached versus 10.0 months, P = 0.018) than the TMB-low group. Conclusions: Toripalimab has demonstrated encouraging clinical activity in the second-line treatment of mUC with a manageable safety profile. PD-L1 expression and TMB were two independent biomarkers in the study.
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