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Nivolumab

(n = 240)

Investigator’s Choice

(n = 121)

Total

(N = 361)

Median age, years

59.0

61.0

60.0

<65, n (%)

172 (71.7)

76 (62.8)

248 (68.7)

Smoking/tobacco use, n (%)

Current/former

191 (79.6)

85 (70.2)

276 (76.5)

Never

39 (16.3)

31 (25.6)

70 (19.4)

ECOG performance status, n (%)

0

49 (20.4)

23 (19.0)

72 (19.9)

1

189 (78.8)

94 (77.7)

283 (78.4)

≥2

1 (0.4)

3 (2.5)

4 (1.1)

Not reported

1 (0.4)

1 (0.8)

2 (0.6)

Number of prior lines of systemic cancer therapy, n (%)

1

106 (44.2)

58 (47.9)

164 (45.4)

2

80 (33.3)

45 (37.2)

125 (34.6)

≥3

54 (22.5)

18 (14.9)

72 (19.9)

p16 status

a,b

, n (%)

Positive

63 (26.3)

29 (24.0)

92 (25.5)

Negative

50 (20.8)

36 (29.8)

86 (23.8)

Not tested

127 (52.9)

56 (46.3)

183 (50.7)

Demographics

Nivolumab in R/M SCCHN After Platinum Therapy

8

a

Required from patients with oropharyngeal cancer only.

b

Determined via p16 immunohistochemistry.

ECOG = Eastern Cooperative Oncology Group.