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ORR, PFS, AND OS: INTENTION TO TREAT

a

23% of patients in the NIVO + IPI arm and 25% of patients in

the SUN arm had tumor PD-L1 expression ≥1%

b

IRRC-assessed by RECIST v1.1

c

IRRC-assessed

N = 1,096

a

Outcome

NIVO + IPI

N = 550

SUN

N = 546

ConfirmedORR,

b

% (95%

CI)

39 (35–43)

32 (28–36)

P

= 0.0191

PFS,

c

median (95% CI),

months

12.4 (9.9–

16.5)

12.3 (9.8–

15.2)

HR (99.1% CI) 0.98 (0.79–

1.23)

P

= 0.8498

550 523 492 464 443 426 404 339 197 71 4 0

546 506 471 432 402 363 334 283 173 66 6 0

Overall Survival (Probability)

0.8

0.9

1.0

0.4

0.5

0.6

0.7

0

6

12

18

24

0.1

0.0

0.2

0.3

33 30

3

9

15

21

27

Months

No. at Risk

NIVO + IPI

HR (99.8% CI) 0.68 (0.49–0.95)

P

= 0.0003

Median OS, months (95% CI)

NIVO + IPI

NR (NE–NE)

SUN

32.9 (NE–NE)

Secondary endpoint

Escudier B, et al. ESMO 2017; LBA5