Table 4.

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

		ORR		TTF		OS
	Total	N	% (95% CI)	No of events	Median TTF, months (95% CI)	No of events	12-month OS rate, % (95% CI)
RCC
Overall	58	18	31 (20 to 45)	41	7 (4 to 10)	21	78 (63 to 87)
Baseline symptomatic
Yes	17	7	41 (18 to 67)	12	7 (2 to 19)	8	68 (40 to 86)
No	41	11	27 (14 to 43)	29	7 (4 to 10)	13	82 (63 to 91)
Treatment line
First line	20	10	50 (27 to 73)	14	7 (4 to 20)	3	86 (54 to 96)
Second line or more	38	8	21 (10 to 37)	27	6 (3 to 9)	18	73 (55 to 85)
Type of treatment
Anti-PD-1/PD-L1	38	8	21 (10 to 37)	25	7 (4 to 11)	16	74 (55 to 85)
Anti-PD-1/PD-L1 +anti-CTLA-4	9	2	22 (3 to 60)	6	6 (2 to 10)	1	100
Anti-PD-1/PD-L1 +anti-VEGF	11	8	73 (39 to 94)	10	5 (4 to 18)*	4	82 (45 to 95)
UC
Overall	48	19	40 (26 to 55)	41	5 (2 to 9)	18	63 (47 to 76)
Baseline symptomatic
Yes	18	5	28 (10 to 53)	14	4 (1 to 20)	8	49 (23 to 71)
No	30	14	47 (28 to 66)	27	5 (2 to 12)	10	71 (51 to 85)
Treatment line
First line	22	8	36 (17 to 59)	17	5 (2 to 9)	6	69 (43 to 85)
Second line or more	26	11	42 (23 to 63)	24	3 (2 to 12)	12	59 (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.