Table 1.

Primary efficacy results

LenvatinibPlacebo
N = 261N = 131
PFS (IRR)
 Median PFS in months (95% CI)18.3 (15.1–NR)3.6 (2.2–3.7)
 HR (95% CI)a0.21 (0.16–0.28)
P valueb<0.001
ORRc
 ORR (95% CI)65% (59–71)2% (0–4)
P valuec<0.001
OS
 Median OS in months (95% CI)NR (22.1–NR)NR (20.3–NR)
 HR (95% CI)a0.73 (0.50–1.07)
P valuec0.10

Abbreviations: IRR, independent radiology review; NR, not reached.

  • aCox proportional hazard model stratified by region (Europe vs. North America vs. other), age group (≤65 years vs. >65 years), and previous VEGF/VEGFR-targeted therapy (0 vs. 1).

  • bCochran–Mantel–Haenszel χ2 test.

  • cLog-rank test stratified by region (Europe vs. North America vs. other), age group (≤65 years vs. >65 years), and previous VEGF/VEGFR-targeted therapy (0 vs. 1).