Table 3.

Clinical activity at week 6 CT in patients with BRAFV600 mutation–positive melanoma with measurable disease who had not previously received a BRAF or MEK inhibitor and without untreated brain metastases from part 2

Week 6 tumor size (RECIST)
Dose levelNBaseline mean (SE)Mean % change (SE)RR (95% CI)
150 mg BID20146 (21)−31 (4)60 (36–81)
50 mg BIDa18104 (21)−20 (6)b22 (6–48)
  • aA lower-dose cohort (50 mg BID) was included in part 2 of this study to better define the dose-efficacy relationship. Among the first 15 patients with BRAFV600E mutations treated at 50 mg BID, only three patients (20%) had a confirmed PR at the time of the interim analysis, which was less than the number of confirmed responses (n = 4) required to continue enrollment on this cohort.

  • bTwo of the 18 patients did not have lesion measurement on week 6, so n = 16 for mean% change calculation.