Table 4

Efficacy outcomes: subset analyses based on autoimmune disorder (AD) baseline symptom status, treatment line and type of treatment

ORRTTFOS
TotalN% (95% CI)No of eventsMedian TTF, months (95% CI)No of events12-month OS rate, % (95% CI)
RCC
Overall581831 (20 to 45)417 (4 to 10)2178 (63 to 87)
Baseline symptomatic
 Yes17741 (18 to 67)127 (2 to 19)868 (40 to 86)
 No411127 (14 to 43)297 (4 to 10)1382 (63 to 91)
Treatment line
 First line201050 (27 to 73)147 (4 to 20)386 (54 to 96)
 Second line or more38821 (10 to 37)276 (3 to 9)1873 (55 to 85)
Type of treatment
 Anti-PD-1/PD-L138821 (10 to 37)257 (4 to 11)1674 (55 to 85)
 Anti-PD-1/PD-L1 +anti-CTLA-49222 (3 to 60)66 (2 to 10)1100
 Anti-PD-1/PD-L1 +anti-VEGF11873 (39 to 94)105 (4 to 18)*482 (45 to 95)
UC
Overall481940 (26 to 55)415 (2 to 9)1863 (47 to 76)
Baseline symptomatic
 Yes18528 (10 to 53)144 (1 to 20)849 (23 to 71)
 No301447 (28 to 66)275 (2 to 12)1071 (51 to 85)
Treatment line
 First line22836 (17 to 59)175 (2 to 9)669 (43 to 85)
 Second line or more261142 (23 to 63)243 (2 to 12)1259 (37 to 76)
  • *Reasons of discontinuation among the eight patients who achieved complete response or partial response: toxicity (n=3), physician choice (n=2), progressive disease (n=2) and unknown (n=1).

  • CTLA-4, cytotoxic T lymphocyte associated protein-4; irAE, immune-related adverse event; ORR, overall response rate; OS, overall survival; PD-1, programmed death-1; PD-L1, programmed death ligand-1; RCC, renal cell carcinoma; TTF, time-to-treatment failure; UC, urothelial carcinoma; VEGF, vascular endothelial growth factor.