Skip to main content
. 2021 Jul 15;9(7):e002552. doi: 10.1136/jitc-2021-002552

Table 6.

Large phase II and III clinical trials investigating ICIs for mUC

Results for immunotherapy treatment
Trial Design Interventions (n patients) ORR Median DOR OS Median PFS
IMvigor210, cohort I (NCT02951767)31 97 Phase II, single-arm, open-label Atezolizumab (first-line) (n=119) 24% (95% CI 16% to 32%) Median not reached (2-year follow-up) 2-year OS 41% (95% CI 32% to 50%) 2.7 months (95% CI 2.1 to 4.2)
IMvigor210, cohort II (NCT02108652)17 97 Phase II, single-arm, open-label Atezolizumab (R/R) (n=310) 16% (95% CI 13% to 21%) 27.7 months (95% CI 2.1 to 33.4) 2-year OS 23% (95% CI 19% to 28%) 2.1 months (95% CI 2.1 to 2.1)
IMvigor211 (NCT02302807)28 Phase III, randomized, open-label Atezolizumab vs chemotherapy
(R/R) (n=931)
PD-L1 IC2/3: 23%
ITT: 13.4%
PD-L1 IC2/3: 15.9 months (95% CI 10.4 to NE)
ITT: 12.7 months (95% CI 13.0 to 21.7)
Median OS
PD-L1 IC2/3: 11.1 months (95% CI 8.6 to 15.5)
ITT: 8.6 months (95% CI 7.8 to 9.6)
Stratified HR 0.87 (95% CI 0.63 to 1.21; p=0.41)
PD-L1 IC2/3: 2.4 months (95% CI 2.1 to 4.2)
ITT: 2.1 months (95% CI 2.1 to 2.2)
IMvigor130 (NCT02807636)32 Phase III, randomized, double-blind Atezolizumab vs chemotherapy
(first-line) (n=451)
23% (95% CI 19% to 28%) NE (95% CI 15.9 months to NE) Median OS 15.7 months (95% CI 13.1 to 17.8)
Stratified HR 0.83, (95% CI 0.69 to 1.00; one-sided p=0.027)
NR
IMvigor130 (NCT02807636)32 Phase III, randomized, double-blind Atezolizumab+gemcitabine/platinum (first-line) vs chemotherapy (n=362) 47% (95% CI 43% to 52%) 8.5 months (95% CI 7.2 to 10.4) Median OS 16.0 months (95% CI 13.9 to 18.9)
HR (1.02 95% CI 0.83 to 1.24)
8.2 months (95% CI 6.5 to 8.3)
Stratified HR 0.82 (95% CI 0.70 to 0.96; one-sided p=0.007)
JAVELIN Bladder100
(NCT02603432)37
Phase III, randomized, open-label Avelumab maintenance vs best supportive care (n=700) 9.7% (95% CI 6.8% to 13.3%) NR Median OS 21.4 months (95% CI 18.9 to 26.1)
HR 0.69 (95% CI 0.56 to 0.86; p=0.001)
3.7 months (95% CI 3.5 to 5.5)
HR 0.62 (95% CI 0.52 to 0.75)
DANUBE (NCT02516241)100 Phase III, randomized, open-label Durvalumab+tremelimumab vs chemotherapy (first-line) (n=1,126) 36% 11.1 months (95% CI 7.9 to 18.5) Median OS 15.1 months (95% CI 13.1 to 18.0)
Durvalumab monotherapy HR 0.89 (95% CI 0.71 to 1.11; p=0.30)
Durvalumab+tremilumab HR 0.85 (95% CI 0.72 to 1.02; p=0.075)
NR
CheckMate 275 (NCT02387996)113 Phase II, single-arm, open-label Nivolumab (R/R) (n=386) 20.7% (95% CI 16.1% to 26.1%) 20.3 months (95% CI 11.5 to 31.3) 3-year OS 22%; Median OS 8.6 months (95% CI 6.1 to 11.3) 1.9 months (95% CI 1.9 to 2.3)
KEYNOTE-052 (NCT02335424)
156 157
Phase II, single-arm, open-label Pembrolizumab (first-line) (n=374) 24% (95% CI 20% to 29%) Median not reached (1-year follow-up) 1-year OS 47.5% 2 months (95% CI 2 to 3)
KEYNOTE-045 (NCT02256436)116 Phase III, randomized, open-label Pembrolizumab (R/R)
(n=542)
21.1% (95% CI 16.4% to 26.5%) Median not reached (2-year follow-up) 2-year OS 26.9%
HR 0.70 (95% CI 0.57 to 0.85; p<0.001)
2.1 months (95% CI 2.0 to 2.2)
HR 0.96 (p = 0.32)
KEYNOTE-361 (NCT02853305)99 Phase III, randomized, open-label Pembrolizumab+gemcitabine/platinum vs chemotherapy (first-line) (n=542) 54.7% 8.5 months 1-year OS 61.8%
HR 0.86
8.3 months (95% CI 7.5 to 8.5)
HR 0.78 (p=0.0033)
HCRN GU14-182 (NCT02500121)106 Phase II, randomized, double-blind Pembrolizumab maintenance vs placebo (n=108) 23% NR NR 5.4 months
(95% CI 3.1 to 7.3)

CI, confidence interval; DOR, duration of response; HR, hazard ratio; ICI, immune checkpoint inhibitor; ITT, intent-to-treat; mUC, metastatic urothelial cancer; NE, not estimable; NR, not reported; ORR, overall response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PD-L1 IC2/3, PD-L1 expression in ≥5% of tumor-infiltrating immune cells; PFS, progression-free survival; R/R, relapsed/refractory.