Table 2.

Dabrafenib efficacy

Part 1Part 2
CharacteristicDabrafenib 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 response01 (17)0001 (3)
  Partial response2 (67)2 (33)2 (33)7 (41)9 (38)13 (41)
  Stable diseaseb1 (33)3 (50)4 (67)8 (47)13 (54)16 (50)
  Progressive disease0002 (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), months11.0 (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), monthsc35 (15–NE)(NE–NE)13 (13–NE)(NE–NE)14 (13–NE)35 (13–NE)
 1-year progression-free survival rate (95% CI), %c100 (100–100)80 (20–97)100 (100–100)78 (46–92)79 (53–92)85 (64–94)
  • Abbreviation: NE, not estimable.

  • aUsing RANO criteria.

  • bIncludes 5 patients with independent review of stable disease but lacking any confirmation scan results.

  • cKaplan–Meier estimate.