Dabrafenib plus trametinib achieves good overall and progression-free survival in BRAF inhibitor-naïve patients with BRAF V600 mutation-positive metastatic melanoma, a study published online ahead of print in the Journal of Clinical Oncology has shown.1
This analysis reports on the overall survival (OS) and clinical characteristics of BRAF inhibitor–naive long-term responders and survivors treated with dabrafenib plus trametinib from a phase I and II study of patients with BRAF V600 mutation-positive metastatic melanoma.
This analysis included 78 BRAF inhibitor–naive patients treated with dabrafenib 150 mg twice daily plus trametinib 2 mg daily (the 150/2 group): 24 patients were from the nonrandomly assigned (part B) cohort and 54 patients were from the randomly assigned (part C) cohort of the trial.
Progression-free and OS were analyzed separately; baseline characteristics and factors on treatment were analyzed for associations with durable responses and OS.
Progression-free survival was 44%, 22%, and 18% at 1, 2, and 3 years, respectively, for the part B group; and 41%, 25%, and 21% at 1, 2, and 3 years, respectively, for the part C group.
Median OS was 27.4 months for the part B group and 25 months for the part C group. OS for the part B group was 72%, 60%, and 47% at 1, 2, and 3 years, respectively; OS for the part C group was 80%, 51%, and 38%, respectively, at 1, 2, and 3 years, respectively.
Metastases in fewer than 3 organ sites and lower baseline lactate dehydrogenase were associated with prolonged survival. At 3 years, OS was 62% in patients with normal baseline lactate dehydrogenase and 63% in patients with a complete response.
The study results show a median OS of more than 2 years in BRAF inhibitor-naïve patients with BRAF V600 mutation-positive metastatic melanoma who received dabrafenib plus trametinib. In addition, approximately 20% of patients receiving this regimen were progression free at 3 years.
1. Long GV, Weber JS, Infante JR, et al. Overall survival and durable responses in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib combined with trametinib [published online ahead of print January 25, 2016]. J Clin Oncol. doi:10.1200/JCO.2015.62.9345.