GlaxoSmithKline has announced overall survival results from the phase III COMBI-d study which show a statistically significant reduction in the risk of death (HR = 0.71; 95% CI: 0.55 - 0.92; P = 0.011) for the combination of dabrafenib and trametinib compared with dabrafenib alone in patients with BRAF V600E/K mutation-positive metastatic melanoma.
COMBI-d is a double-blind, international study that compared the combination of dabrafenib, a BRAF inhibitor, and trametinib, a MEK inhibitor, to dabrafenib plus placebo in patients with stage IIIC or IV BRAF V600E/K mutation-positive cutaneous melanoma. The study included 423 patients that were randomly assigned to either arm.
Previous analyses showed that the combination decreased the risk of disease progression and/or death by 25% compared with dabrafenib alone (HR = 0.75; 95% CI: 0.57 - 0.99; P = 0.035).
Results showed a median progression-free survival of 9.3 months and 8.8 months in the combination and dabrafenib alone groups, respectively.
Trametinib and dabrafenib have already been approved by the U.S. Food and Drug Administration to be used in combination for the treatment of patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma.
GlaxoSmithKline today announced overall survival (OS) results from COMBI-d which demonstrate a statistically significant reduction in the risk of death for the combination of dabrafenib (Tafinlar™) and trametinib (Mekinist™) compared to dabrafenib monotherapy in patients with BRAF V600E/K mutation-positive metastatic melanoma.