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Objective Response Rates:

Independent Review

n (%)

Lenvatinib (n=261)

Placebo (n=131)

Objective Response Rate

169 (64.8)

2 (1.5)

95% CI

59.0–70.5

0.0–3.6

P

-value

<0.0001

Complete response

4 (1.5)

0

Partial response

165 (63.2)

2 (1.5)

Stable disease

60 (23.0)

71 (54.2)

Stable disease ≥23 weeks

40 (15.3)

39 (29.8)

Progressive disease

18 (6.9)

52 (39.7)

Not evaluable/Unknown

14 (5.4)

6 (4.6)

Disease Control Rate

229 (87.7)

73 (55.7)

95% CI

83.8–91.7

47.2–64.2

P

-value

<0.0001

Clinical Benefit Rate

209 (80.1)

41 (31.3)

95% CI

75.2–84.9

23.4–39.2

P

-value

<0.0001

CI, confidence interval; NR, not reached.

Median time to lenvatinib response: 2.0 months (range, 1.9–3.5 months)

Median duration of lenvatinib response: NR (95% CI, 16.8–NR)

Schlumberger M, et al. N Engl J Med 2015;372:621-30. DOI: 10.1056/NEJMoa1406470