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ANTITUMOR ACTIVITY BY TUMOR PD-L1 EXPRESSION LEVEL

IMDC intermediate/poor risk

Intention to treat

PD-L1 <1%

PD-L1 ≥1%

PD-L1 <1%

PD-L1 ≥1%

Outcome

NIVO + IPI

N = 284

SUN

N = 278

NIVO + IPI

N = 100

SUN

N = 114

NIVO + IPI

N = 386

SUN

N = 376

NIVO + IPI

N = 113

SUN

N = 127

ORR,

a

% (95% CI)

37

(32–43)

28

(23–34)

58

(48–68)

22

(15–31)

36

(31–41)

35

(31–40)

53

(44–63)

22

(15–30)

P

= 0.0252

P

< 0.0001

P

= 0.8799

P

< 0.0001

BOR,

a

%

Complete response

Partial response

Stable disease

Progressive disease

NA

7

30

36

20

7

1

27

47

13

12

16

42

19

14

9

1

21

40

25

13

9

27

39

18

7

2

33

43

11

11

14

39

25

14

8

1

21

43

23

13

a

IRRC-assessed

Exploratory endpoint

Motzer RJ, et al. N Engl J Med 2018;378(14):1277-90