Study of Mekinist + Tafinlar for Metastatic Melanoma published in NEJM - GSK

Results published today in the New England Journal of Medicine show that treatment with the combination of Mekinist (trametinib) and Tafinlar (dabrafenib), from Glaxo Smith Kline, significantly improved overall survival (OS) compared to vemurafenib monotherapy in previously untreated patients with BRAF V600E/K mutation-positive Metastatic Melanoma, without increased overall toxicity. The COMBI-v study demonstrated a 31 per cent decrease in the risk of death for patients treated with the trametinib and dabrafenib combination compared to vemurafenib. Median OS for the vemurafenib arm was 17.2 months; median OS for the combination arm had not been reached. At 12 months, the rate of OS was 72 per cent for the combination arm and 65 per cent for the vemurafenib arm. Treatment with the combination increased median progression-free survival to 11.4 months compared to 7.3 months for the vemurafenib arm.

Overall, treatment with the combination resulted in a 44 per cent reduction in risk of disease progression or death compared to vemurafenib. The objective response rate was 64 per cent (59.1%, 69.4%) for the combination and 51 per cent (46.1%, 56.8%) for vemurafenib; the median duration of response was 13.8 months vs. 7.5 months, respectively. Additionally, 13 per cent of patients treated with the combination achieved a complete response, compared to 8 per cent of patients in the vemurafenib arm. See: "Improved Overall Survival in Melanoma with Combined Dabrafenib and Trametinib" Caroline Robert et al. NEJM November 16, 2014 DOI: 10.1056/NEJMoa1412690