A Comprehensive Review of US FDA-Approved Immune Checkpoint Inhibitors in Urothelial Carcinoma

Table 2

Efficacy outcomes of all tested patients with urothelial carcinoma in US FDA-approved PD-1/PD-L1 inhibitor trials.

Inhibitor target	Treatment regimen	Trial code	NCT identifier	Trial phase	Patient number	ORR (95% CI)	DoR/month (range)	PFS/month (95% CI)	OS/month (95% CI)	Reference
PD-1	Nivolumab	CheckMate-275	NCT02387996	Phase 2	265	19.6% (15.1, 24.9)	10.3	2.0 (1.87, 2.63)	8.74 (6.05, NR)	[36]
	Pembrolizumab	KEYNOTE-045	NCT02256436	Phase 3	542	21% (16.4, 26.5)	—	2.1 (2.0, 2.2)	10.3 (8.0, 11.8)	[38, 39]
		KEYNOTE-052	NCT02335424	Phase 2	370	28.6% (24, 34)	NR (1.4+, 17.8+)	—	—	[40]
PD-L1	Atezolizumab	IMvigor-210	NCT02108652	Phase 2	310	14.8% (11.1, 19.3)	NR (2.1+, 13.8+)	2.1 (2.1, 2.1)	7.90 (6.6, 9.3)	[30, 31]
	Durvalumab	Study 1108	NCT01693562	Phase 1/2	191	17.8 (12.7, 24.0)	NR (0.9+, 19.9+)	1.5 (1.4, 1.9)	18.2 (8.1, NR)	[35]
	Avelumab	JAVELIN	NCT01772004	Phase 1	44	13.3% (9.1, 18.4); 16.1% (10.8, 22.8)	NR (1.4+, 17.4+)	2.9 (1.53, 4.35)	13.7 (8.5, NE)	[37]

ORR: objective response rate; DoR: median duration of response; PFS: median progression-free survival; OS: median overall survival; HR: hazard ratio; CI: confidence interval; NR: not reached; NE: not estimable; follow-up at least 13 weeks; follow-up at least 6 months.