Table 2.
Summary of tumor responses as assessed by investigator using RECIST v1.1
| Tumor responses | Lenvatinib starting dose/day | |
|---|---|---|
| 24 mg (n = 75) | 18 mg (n = 77) | |
| Week 24 | ||
| Best overall response, % (n) | ||
| CR | 0 | 0 |
| PR | 57.3 (43) | 40.3 (31) |
| SDa | 36.0 (27) | 46.8 (36) |
| PD | 2.7 (2) | 5.2 (4) |
| Not evaluable | 4.0 (3) | 7.8 (6) |
| Objective response rate, CR + PR, % (n) [95% CI] | 57.3 (43) [46.1, 68.5] | 40.3 (31) [29.3, 51.2] |
| Difference (18 mg − 24 mg), % (95% CI) | −17.1 (−32.7, −1.4) | |
| Odds ratio (18 mg/24 mg) (95% CI) | 0.50 (0.26, 0.96) | |
| Tumor responses, overall | ||
| Best overall response, % (n) | ||
| CR | 0 | 0 |
| PR | 64.0 (48) | 46.8 (36) |
| SDa | 29.3 (22) | 40.3 (31) |
| Durable SDb | 20.0 (15) | 27.3 (21) |
| PD | 2.7 (2) | 5.2 (4) |
| Not evaluable | 4.0 (3) | 7.8 (6) |
| Objective response rate (CR + PR), % (n) [95% CI] | 64.0 (48) [53.1, 74.9] | 46.8 (36) [35.6, 57.9] |
| Difference (18 mg − 24 mg), % (95% CI) | −17.2 (−32.8, −1.7) | |
| Odds ratio (18 mg/24 mg) (95% CI) | 0.50 (0.26, 0.95) | |
| Clinical benefit rate (CR + PR + durable SD), % (n) [95% CI] | 84.0 (63) [75.7, 92.3] | 74.0 (57) [64.2, 83.8] |
| Disease control rate (CR + PR + SD), % (n) [95% CI] | 93.3 (70) [87.7, 99.0] | 87.0 (67) [79.5, 94.5] |
| Time to first objective response, months, median (95% CI) | 3.7 (2.0, 3.9) | 5.8 (3.8, 18.3) |
| Duration of response,c months, median (95% CI) | NE (18.4, NE) | 20.8 (15.1, NE) |
Abbreviations: CR, complete response; NE, not estimable; PD, progressive disease; PR, partial response; RECIST v1.1, Response Evaluation Criteria In Solid Tumors version 1.1; SD, stable disease.
aStable disease is defined as 7 or more weeks after randomization.
bDurable SD is defined as SD for ≥23 weeks.
cAmong patients who had an objective response: lenvatinib 24-mg arm n = 48, lenvatinib 18-mg arm n = 36.