Dabrafenib efficacy
Part 1 | Part 2 | |||||
---|---|---|---|---|---|---|
Characteristic | Dabrafenib 3.75 mg/kg (n = 3) | Dabrafenib 4.5 mg/kg (n = 6) | Dabrafenib 5.25 mg/kg (n = 6) | Dabrafenib RP2D (n = 17) | All patients treated with dabrafenib at RP2D (n = 24) | All patients with LGG (N = 32) |
Independent reviewa | ||||||
Best overall response, n (%) | ||||||
Complete response | 0 | 1 (17) | 0 | 0 | 0 | 1 (3) |
Partial response | 2 (67) | 2 (33) | 2 (33) | 7 (41) | 9 (38) | 13 (41) |
Stable diseaseb | 1 (33) | 3 (50) | 4 (67) | 8 (47) | 13 (54) | 16 (50) |
Progressive disease | 0 | 0 | 0 | 2 (12) | 2 (8) | 2 (6) |
Objective response, n (%) [95% CI] | 2 (67) [9–99] | 3 (50) [12–88] | 2 (33) [4–78] | 7 (41) [18–67] | 9 (38) [19–59] | 14 (44) [26–62] |
Median duration of response (range), months | — | — | — | — | 11.0 (3.7–14.5) | 11.0 (7.4–14.5) |
Disease control, n (%) [95% CI] | 3 (100) [29–100] | 5 (83) [36–100] | 5 (83) [36–100] | 12 (71) [44–90] | 18 (75) [53–90] | 25 (78) [60–91] |
Median progression-free survival (95% CI), monthsc | 35 (15–NE) | (NE–NE) | 13 (13–NE) | (NE–NE) | 14 (13–NE) | 35 (13–NE) |
1-year progression-free survival rate (95% CI), %c | 100 (100–100) | 80 (20–97) | 100 (100–100) | 78 (46–92) | 79 (53–92) | 85 (64–94) |