Table 3.
Efficacy End Points in Part C, as Assessed by the Site Investigators (Intention-to-Treat Population).*
| End Point | Dabrafenib Monotherapy (N = 54) | Combination 150/1 (N = 54) | Combination 150/2 (N = 54) |
|---|---|---|---|
| Progression-free survival — mo | |||
| Median (95% CI) | 5.8 (4.6–7.4) | 9.2 (6.4–11.0) | 9.4 (8.6–16.7) |
| Hazard ratio for death or progression (95% CI) | Reference | 0.56 (0.37–0.87) | 0.39 (0.25–0.62) |
| P value | Reference | 0.006 | <0.001 |
| Progression-free survival at 12 mo (95% CI) — % | 9 (3–20) | 26 (15–39) | 41 (27–54) |
| Best response — no. (%) | |||
| Complete response | 2 (4) | 3 (6) | 5 (9) |
| Partial response | 27 (50) | 24 (44) | 36 (67) |
| Stable disease | 22 (41) | 24 (44) | 13 (24) |
| Progressive disease | 3 (6) | 2 (4) | 0 |
| Could not be evaluated | 0 | 1 (2) | 0 |
| Complete or partial response | |||
| No. of patients | 29 | 27 | 41 |
| Percent of patients (95% CI) | 54 (40–67) | 50 (36–64) | 76 (62–86) |
| P value | Reference | 0.77 | 0.03 |
| Duration of response — mo | |||
| Median | 5.6 | 9.5 | 10.5 |
| 95% CI | 4.5–7.4 | 7.4–NA | 7.4–14.9 |
*
Hazard ratios and P values are for the comparison between each combination-therapy group and the monotherapy group. NA denotes not achieved.