Table 2.
Summary of tumor response per investigator assessment.
Parameter | Lenvatinib (n = 261) | Placebo (n = 131) |
---|---|---|
Best overall response, n (%) | ||
CR | 5 (1.9) | 1 (0.8) |
PR | 152 (58.2) | 2 (1.5) |
SD | 79 (30.3) | 77 (58.8) |
Durable SD | 57 (21.8) | 51 (38.9) |
PD | 10 (3.8) | 45 (34.4) |
NE | 2 (0.8) | 2 (1.5) |
Unknown | 13 (5.0) | 4 (3.1) |
Objective response rate, n (%) | 157 (60.2) | 3 (2.3) |
95% CI | 54.2−66.1 | 0.0−4.9 |
Median time to first objective response, months (95% CI) | 3.5 (1.9−3.7) | 9.4 (1.8−11.0) |
DCR, n (%) | 236 (90.4) | 80 (61.1) |
95% CI | 86.9−94.0 | 52.7−69.4 |
CBR, n (%) | 214 (82.0) | 54 (41.2) |
95% CI | 77.3−86.7 | 32.8−49.7 |
Median duration of SD, months (95% CI) | 9.6 (7.6−14.8) | 5.7 (5.5−7.4) |
Updated data, cutoff: 1 September 2016.
CBR, clinical benefit rate; CI, confidence interval; CR, complete response; DCR, disease control rate; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease.