Table 1.
Response Outcomes Based on Prior Sorafenib/Lenvatinib Treatment
| Prior sorafenib only |
Prior lenvatinib only |
Prior lenvatinib and sorafenib |
||||
|---|---|---|---|---|---|---|
| Cabozantinib n = 63 | Placebo n = 33 | Cabozantinib n = 68 | Placebo n = 34 | Cabozantinib n = 39 | Placebo n = 21 | |
| Median duration of study follow-up, months | 9.1 | 9.9 | 10.7 | |||
| Objective response rate, % [95% CI] | 21 [11.5–32.7] | 0 [0–10.6] | 4 [0.9–12.4] | 0 [0–10.3] | 8 [1.6–20.9] | 0 [0–16.1] |
| Best overall confirmed response, n (%) | ||||||
| Confirmed complete response | 0 | 0 | 1 (1) | 0 | 0 | 0 |
| Confirmed partial response | 13 (21) | 0 | 2 (3) | 0 | 3 (8) | 0 |
| Stable disease | 42 (67) | 15 (45) | 46 (68) | 11 (32) | 29 (74) | 8 (38) |
| Stable disease ≥16 weeks | 31 (49) | 8 (24) | 25 (37) | 5 (15) | 15 (38) | 4 (19) |
| Progressive disease | 1 (2) | 14 (42) | 7 (10) | 19 (56) | 3 (8) | 9 (43) |
| Not evaluable/missing/no measurable disease | 7 (11) | 4 (12) | 12 (18) | 4 (12) | 4 (10) | 4 (19) |
| Disease stabilization rate, % [95% CI]a | 70 [57.0–80.8] | 24 [11.1–42.3] | 41 [29.4–53.8] | 15 [5.0–31.1] | 46 [30.1–62.8] | 19 [5.4–41.9] |
| Time to response, median (range), months | 3.6 (1.8–7.5) | NA | 3.6 (1.7–3.8) | NA | 3.2 (1.8–3.7) | NA |
Tumor response was assessed with the use of Response Evaluation Criteria in Solid Tumors version 1.1 and was confirmed by BIRC.
a
Exploratory endpoint: complete or partial response or stable disease for ≥16 weeks.
BIRC, blinded independent radiology committee; CI, confidence interval; NA, not applicable.