23 October 2017 - First targeted combination therapy to demonstrate a clinical benefit in patients with a BRAF V600E/K mutation in the adjuvant setting.

Novartis today announced that the US FDA has granted breakthrough therapy designation for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection. Tafinlar in combination with Mekinist is in development to become the first adjuvant treatment specifically for melanoma patients with a BRAF V600 mutation.

The designation is based on results from COMBI-AD, a Phase III study of 870 patients with stage III BRAF V600E/K mutation-positive melanoma after complete surgical resection treated with Tafinlar and Mekinist. Patients received the Tafinlar (150 mg BID) and Mekinist (2 mg QD) combination (n = 438) or matching placebos (n = 432). After a median follow-up of 2.8 years, the primary endpoint of relapse-free survival (RFS) was met. Treatment with the combination therapy significantly reduced the risk of disease recurrence or death by 53% vs. placebo (HR: 0.47 [95% CI: 0.39-0.58]; median not reached vs. 16.6 months, respectively; p<0.001). The RFS benefit among the combination arm was observed across all patient subgroups, including stage III A, B and C. These results were recently presented at the European Society for Medical Oncology Congress and published in the New England Journal of Medicine.

Read Novartis press release