Dr. Postow on FDA Approval of Adjuvant Dabrafenib Plus Trametinib in BRAF-Mutant Melanoma

Michael A. Postow, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses the FDA approval of dabrafenib (Tafinlar) plus trametinib (Mekinist) as an adjuvant treatment for patients with BRAF V600E— or V600K–positive stage III melanoma following complete resection.

The FDA recently approved the combination of dabrafenib and trametinib for the adjuvant treatment of patients with BRAF V600E— or V600K–positive stage III melanoma following complete resection.

The approval is based on data from the phase III COMBI-AD trial, in which adjuvant treatment with dabrafenib and trametinib was found to reduce the risk of relapse or death by 53% versus placebo for patients with BRAF-mutant stage III melanoma. After a median follow-up of 2.8 years, the 3-year relapse-free survival rate with dabrafenib and trametinib was 58% versus 39% for placebo (HR, 0.47; 95% CI, 0.39-0.58; P <.001).