Table 3.

Antitumour activity summary by dose level, in combined cohorts, and by PD-L1 status (confirmed responses)^*

Antitumour activity by dose level
n (%)	D3 q4w T1 n=3	D10 q4w T1 n=3	D15 q4w T1 n=12	D20 q4w T1 n=8	D10 q2w T1 n=3	D10 q4w T3 n=3	D15 q4w T3 n=10	D20 q4w T3 n=6	D10 q2w T3 n=6	D15 q4w T10 n=9	All cohorts N=63
All evaluable patients with ≥24 weeks follow-up
ORR	0 (0)	0 (0)	3 (25)	3 (38)	0 (0)	1 (33)	2 (20)	1 (17)	1 (17)	0 (0)	11 (17)
DCR (CR, PR, SD ≥24 weeks)	0 (0)	1 (33)	5 (42)	3 (38)	0 (0)	2 (67)	4 (40)	1 (17)	1 (17)	1 (11)	18 (29)

Antitumour activity − combined cohorts
n (%; 95% CI)	D10−20 q4/2w T1† n=26	D10−20 q4/2w T3 n=25	D15 q4w T10 n=9	All cohorts N=63
All evaluable patients with ≥24 weeks follow-up
ORR	6 (23; 9−44)	5 (20; 7−41)	0 (0; 0−34)	11 (17; 9−29)
DCR (CR, PR, SD ≥24 weeks)	9 (35; 17−56)	8 (32; 15−54)	1 (11; 0−48)	18 (29; 18−41)
PD-L1+ (≥25%)	n=9	n=5	n=4	n=18
ORR	2 (22; 3−60)	2 (40; 5−85)	0 (0; 0−60)	4 (22; 6−48)
DCR (CR, PR, SD ≥24 weeks)	3 (33; 8−70)	2 (40; 5−85)	1 (25; 1−81)	6 (33; 13−59)
PD-L1−
PD-L1 <25%	n=14	n=17	n=4	n=37
ORR	4 (29; 8−58)	2 (12; 2−36)	0 (0; 0−60)	6 (16; 6−32)
DCR (CR, PR, SD ≥24 weeks)	6 (43; 18−71)	5 (29; 10−56)	0 (0; 0−60)	11 (30; 16−47)
PD-L1 0%	n=10	n=10	n=3	n=24
ORR	4 (40; 12−74)	1 (10; 0−45)	0 (0; 0−71)	5 (21; 7−42)
DCR (CR, PR, SD ≥24 weeks)	5 (50; 19−81)	3 (30; 7−65)	0 (0; 0−71)	8 (33; 16−55)
PD-L1 unknown	n=3	n=3	n=1	n=8
ORR	0 (0; 0−71)	1 (33; 1−91)	0 (0; 0−98)	1 (13; 0−53)
DCR (CR, PR, SD ≥24 weeks)	0 (0; 0−71)	1 (33; 1−91)	0 (0; 0−98)	1 (13; 0−53)

^*Includes confirmed CR or PR. In patients with measurable disease at baseline, ≥1 follow-up scan includes those that discontinued due to progressive disease or death without any follow-up scan. All patients were dosed ≥24 weeks prior to the cutoff date.

^†Excludes D3 q4w T1 cohort (n=3)

CR= complete response; D=durvalumab; DCR=disease control rate; ORR=objective response rate; PD-L1=programmed cell death ligand-1; PR=partial response; q=every; SD=stable disease; T=tremelimumab; w=weeks.