Urothelial carcinoma: the evolving landscape of immunotherapy for patients with advanced disease

Figures & data

Table 1 Summary of responses for immune checkpoint inhibitors in patients with advanced urothelial carcinoma

Agent/study	Number of patients (n)	ORR, %	CR, %	Median OS, months	PD-L1 diagnostic partner/Mab clone/Definition of PD-L1 expression for subgroup analysis
Previously treated patients
Atezolizumab, IMvigor 210 (cohort 2), NCT02108652	310	14.8	5.5	7.9	Ventana/Rabbit SP142
					IC0 (IC <1%)
					IC1 (IC ≥1% and <5%)
					IC2/3 (IC ≥5%)
Pembrolizumab, KEYNOTE-045, NCT02256436	542 (270 randomized to pembrolizumab arm)	21.1	7	10.3	Dako/Mouse 22C3
					PD-L1 ≥10%
Nivolumab, CheckMate 032, NCT01928394	78	24.4	6	9.7	Dako/Rabbit 28-8
					PD-L1 ≥1%
Nivolumab, CheckMate 275, NCT02387996	270	19.6	2	8.7	Dako/Rabbit 28-8
					PD-L1 ≥1% and ≥5%
Durvalumab, NCT01693562	191	17.8	3.7	18.2 (immature)	Ventana/Rabbit SP263
					PD-L1≥25% TC or IC
Avelumab, NCT01772004	44	18.2	11.4	13.7	Dako/Rabbit 73-10
					PD-L1≥5%
First-line cisplatin ineligible
Atezolizumab, IMvigor 210 (cohort 1), NCT02951767	119	23	9	15.9	Ventana/Rabbit SP142
					IC0 (IC <1%)
					IC1 (IC ≥1% and <5%)
					IC2/3 (IC ≥5%)
Pembrolizumab, KEYNOTE-052, NCT02335424	370	29	7	Not reported	Dako/Mouse 22C3
					PD-L1 ≥10%

Abbreviations: CR, complete response; OS, overall survival; PD-L1, programmed death-ligand 1; ORR, overall response rate; IC, immune cell; TC, tumor cell; Mab, mono clonal antibody.

Table 2 First-line immunotherapy trials in bladder cancer

Study	NCT trial number	Treatment arms	Phase of study	Estimated completion date
Danube	NCT02516241	Durvalumab + tremelimumab versus durvalumab versus standard chemotherapy	Phase II	July 15, 2019
IMvigor 130	NCT02807636	Atezolizumab versus atezolizumab in combination with platinum-based chemotherapy versus platinum-based chemotherapy	Phase III	July 30, 2020
KEYNOTE-361	NCT02853305	Pembrolizumab with or without platinum-based chemotherapy versus platinum-based chemotherapy	Phase III	March 28, 2020
HCRN GU10-148	NCT01524991	Ipilimumab in combination with gemcitabine and cisplatin	Phase II	March 2018