Trametinib and dabrafenib(GSK) success in BREAK 3 and METRIC studies for Melanoma - 05-Jun-2012

GSK announced at the Annual Meeting of the American Society of Clinical Oncology in Chicago positive results for investigational BRAF and MEK inhibitors dabrafenib and trametinib.The BREAK 3 study of dabrafenib (BRAF inhibitor) and the METRIC study of trametinib (MEK inhibitor) demonstrated a statistically significant benefit in the length of time patients with BRAF V600 mutation positive advanced or Metastatic Melanoma lived without progression of their disease or death (Progression Free Survival or PFS) compared to those receiving chemotherapy. Additionally, patients in the METRIC study who received trametinib lived significantly longer (Overall Survival) than those who received chemotherapy with dacarbazine. Overall survival data are not yet mature in the BREAK 3 trial. In the BREAK 3 study, dabrafenib treatment reduced the risk of disease progression or death by 70% (Hazard Ratio (HR) 0.30; p<0.0001) compared to chemotherapy. The median PFS was 5.1 months in the dabrafenib arm compared with 2.7 months in the dacarbazine arm.In the METRIC study, the median PFS of 4.8 months in the trametinib arm was significantly greater than the 1.5 month median PFS in the chemotherapy arm with a 55% reduction in risk of disease progression or death (HR 0.45; p<0.0001) in the trametinib arm. Additionally, a significant Overall Survival benefit was gained by the trametinib arm at the interim analysis (HR 0.54;p=0.0136). see N Engl J Med 2012 Doi 10.1056/NEJMoa1203421-"Improved Survival with MEK Inhibition in BRAF-Mutated Melanoma -Keith T. Flaherty, M.D., Caroline Robert, M.D., Ph.D., Peter Hersey, M.D., Ph.D……., for the METRIC Study Group