Biomarkers for immunotherapy in bladder cancer: a moving target

Table 1 Response rates and median overall survival with FDA approved anti-PD-1/PD-L1 blockade in metastatic urothelial carcinoma

	Medication	Phase		# Patients	ORR (%)	PFS (m.)	OS (m.)	PD-L1 Response	Reference
Metastatic 2nd Line Therapy	Atezolizumab	I		100	21.0	–	8	–	Powles et al. [7]
	Atezolizumab	II		310	15.0	2.1	7.9	PD-L1 on IC > 5% associated with ORR, testing not required for treatment	Rosenberg et al. [8]
	Pembrolizumab	III	P	270	21.6	2.1	10.3	PD-L1 TC and IC composite score > 10%, no difference in ORR or mOS	Bellmunt et al. [13]
	Pembrolizumab	III	C	272	6.7	3.3	7.4	–	Bellmunt et al. [13]
	Nivolumab	II		270	19.6	2.0	8.74	PD-L1 on TC > 1% not associated with ORR but associated with OS	Sharma et al. [11]
	Avelumab	Ib/II		241	17.6	1.6	7.0	PD-L1 on TC > 5% associated with improved ORR, no OS data as of yet	Apolo et al. [22] Patel et al. [23]
	Durvalumab	Ib		191	17.8	–	–	Composite biomarker of PD-L1 > 25% on TC or IC predicts response rates, approved companion diagnostic	Massard et al. [19, 21]
Metastatic 1st Line*	Atezolizumab	II		100	23.0	2.7	15.9	PD-L1 on IC not associated with improved ORR or mOS	Balar et al. [10]
Metastatic 1st Line*	Pembrolizumab	II		370	29.0	–	–	PD-L1 TC and IC composite score with cutoff of 10%, no difference noted in ORR	Balar et al. [16]