Tafinlar (dabrafenib) + Mekinist (trametinib) superior to Tafinlar monotherapy in three year analysis of BRAF mutation advanced melanoma.- Novartis

Novartis announced data from a Phase III study showing a significant survival benefit for patients with BRAF V600E/K mutation-positive advanced melanoma when treated with the first-line combination of Tafinlar (dabrafenib) + Mekinist (trametinib) compared to Tafinlar monotherapy. The results from the COMBI-d three-year follow-up analysis represent one of the longest survival follow-up studies to date with BRAF mutation-positive advanced melanoma patients.

Results are being presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Results from the COMBI-d study of 423 patients found the estimated three-year survival rate to be 44% for patients receiving the combination of Tafinlar + Mekinist (95% CI, 36.4%-50.5%) compared with 32% who received Tafinlar alone (95% CI, 25.4%-38.3%). There were 26 patients who crossed over from the monotherapy arm to the combination arm after the combination demonstrated a significant overall survival (OS) benefit in a prior analysis. Additionally, the estimated three-year progression-free survival rate was 22% (95% CI, 16.2%-28.0%) for the combination arm and 12% (95% CI, 7.1%-18.0%) for the monotherapy arm. In an analysis of patients with normal lactate dehydrogenase (LDH) levels and fewer than three disease sites, the three-year survival rate for combination was 62% (95% CI, 49.3%-72.0%) compared with 45% who received Tafinlar alone (95% CI, 34.9%-55.1%). In advanced melanoma, a patient's LDH level is often predictive of prognosis and may be a predictor of treatment response.