. Author manuscript; available in PMC: 2018 Jul 20.

Published in final edited form as: Nat Rev Clin Oncol. 2016 Nov 22;14(4):221–234. doi: 10.1038/nrclinonc.2016.188

Table 7 |.

Trials evaluating anti-PD-L1/PD-1 antibodies in patients with previously treated, metastatic urothelial cancer

	Rosenberg et al.¹¹⁸	Plimack et al.¹¹⁹	Apolo et al.¹²⁰	Massard et al.¹²¹	Sharma et al.¹²²	Galsky et al.¹²³
Phase	II	Ib	Ib	I/II	I/ll	II
Therapeutic antibody evaluated	Atezolizumab	Pembrolizumab	Avelumab	Durvalumab	Nivolumab	Nivolumab
Antibody target	PD-L1	PD-1	PD-L1	PD-L1	PD-1	PD-1
Number of patients evaluable for response	310	29	44	42	78	265
Proportion of patients treated with ≥2 prior lines of therapy	42%	51.5%	52.3%	31%	66.6%	29.3%
*Breakdown of PD-L1 scores/positivity^ (proportion of patients)**	IC 0/1: 68% IC 2/3: 23%	PD-L1^*: 100%	PD-L1^*: 31.3%	PD-L1^*: 67%	PD-L1^*: 37.3%	PD-L1^*: 45.9%
ORR (RECIST v1.1)	15%	27.6%	15.9%	31%	24.4%	19.6%
CR rate (RECIST v1.1)	5%	10.3%	2.3%	Not reported	6.4%	2.3%
Median follow-up duration	11.7 months	15 months	3.5 months	6.5 months	9 months	7 months
Median DOR	Not yet reached	Not yet reached	Not yet reached	Not yet reached	Not yet reached	Not yet reached
Rate of grade 3–4 AEs	16%	15.2%	2.3%	4.9%	22%	17.8%

AEs, adverse events; CR, complete response; DOR, duration of response; IC, score based on percentage of PD-L1-positive tumour-infiltrating immune cells; ORR, objective response rate; PD-1, programmed cell-death protein 1; PD-L1, programmed cell death 1 ligand 1.

Methodology of PD-L1 score ascertainment varied based on the study.