Table 2.
Efficacy Outcomes
| Category | Patients Treated With Lenvatinib 24 mg Once Daily (N = 26) | |
|---|---|---|
| Investigator Assessment | IIR | |
|
Objective response rate, n (%) (90% CI) |
3 (11.5) (3.2–27.2) |
3 (11.5) (3.2–27.2) |
| Best overall response, n (%) | ||
| Complete response | 0 | 0 |
| Partial response | 3 (11.5) | 3 (11.5) |
| Stable disease | 19 (73.1) | 9 (34.6) |
| Progressive disease | 4 (15.4) | 13 (50.0) |
| Not evaluable | 0 | 0 |
| Unknown | 0 | 1 (3.8) |
|
Disease control ratea, n (%) (90% CI) |
22 (84.6) (68.2–94.6) |
12 (46.2) (29.2–63.8) |
|
Clinical benefit rateb, n (%) (90% CI) |
10 (38.5) (22.6–56.4) |
6 (23.1) (10.6–40.5) |
| PFS rate at 12 weeks, % (95% CI) | 72.2 (50.4–85.7) | 44.0 (24.5–61.9) |
| Median PFS, months (95% CI) | 3.19 (2.79–7.23) | 1.64 (1.41–3.19) |
| Median time to progression, months (95% CI) | 4.11 (2.76–7.39) | 1.64 (1.41–2.92) |
| Median overall survival, months (95% CI) | 7.35 (4.50–11.27) | |
CI confidence interval, IIR independent imaging review, PFS progression-free survival
aThe proportion of patients with a best overall response of complete response, partial response or stable disease; stable disease needed to be achieved at cycle 2 day 8 or later
bThe proportion of patients with complete response + partial response + durable stable disease (≥ 23 weeks)