Table 1. . Key trials in urothelial carcinoma.

Study	Arm	n	ORR	OS (months)	Treatment-related adverse events (%)
Second-line setting, after failure of platinum-based therapy
Phase II single-agent IMvigor210 [17]	Atezolizumab	310	All pts = 16%, CR: 7% High PD-L1 = 28%, CR: 15%	All pts = 7.9 1-year OS = 37% High PD-L1 = 11.9 1-year OS = 50%	Any grade = 66% Grade 3–4 = 16%
Phase III randomized IMvigor 211 [18]	Atezolizumab	467	All pts = 14%, CR: 4% High PD-L1 = 23%	All pts = 8.9 1-year OS = 40% High PD-L1 = 11.1	Any grade = 70% Grade 3–4 = 20%
Vinflunine or paclitaxel or docetaxel	464	All pts = 15%, CR: 4% High PD-L1 = 22%	All pts = 8.2 1-year OS = 33% High PD-L1 = 10.6	Any grade = 89% Grade 3–4 = 43%
Phase II single-agent Checkmate 275 [19,21]	Nivolumab	265	All pts = 19.6% High PD-L1 = 28.4 Low PD-L1 = 16.1%	All pts = 8.7 1-year OS = 41% High PD-L1 = 11.3 Low PD-L1 = 5.95	Any grade = 64% Grade 3–4 = 18%
Phase III randomized Keynote-045 [23]	Pembrolizumab	270	All pts = 21.1%, CR: 7%	All pts = 10.3 High PD-L1 = 8	Any grade = 61.3% Grade 3–4 = 16.5%
Vinflunine or paclitaxel or docetaxel	272	All pts = 11.4%, CR: 3.3%	All pts = 7.4 High PD-L1 = 5.2	Any grade = 90.2% Grade 3–4 = 49.8%
Phase I/II single-agent [24,25]	Durvalumab	182	All pts = 17% High PD-L1 = 26.3% Low PD-L1 = 4.1%	All pts = 14.1 1-year OS = 50%	Any grade 60.7% Grade 3–4 = 6.8%
Phase Ib single-agent (Javelin) [26,27]	Avelumab	242	All pts = 16.1% High PD-L1 = 25% Low PD-L1 = 14.7%	All pts = 7.4 1-year OS = 54.9%	Any grade = 66.7% Grade 3–4 = 8.4%
First-line setting, in cisplatin-ineligible patients
Phase II single-agent IMvigor210 cohort 1 [28]	Atezolizumab	119	All pts = 24%, CR: 7% High PD-L1 = 24%	All pts = 15.9 High PD-L1 = 12.3 Low PD-L1 = 19.1	Any grade = 66% Grade 3–4 = 18%
Phase II single-agent Keynote-052 [29]	Pembrolizumab	370	All pts = 29%, CR: 7%	6-month OS = 67%	Any grade = 62% Grade 3–4 = 16%

CR: Complete response; ORR: Objective response rate; OS: Overall survival; PD-L1: Programmed death ligand-1; Pts: Patients.