GSK presents positive results for investigational BRAF and MEK inhibitors dabrafenib and trametinib at ASCO

Top Quote Phase III studies of single agent therapy in metastatic melanoma with BRAF V600 mutations meet primary endpoints End Quote
  • (1888PressRelease) June 04, 2012 - Findings from GlaxoSmithKline (GSK) plc’s Phase III clinical study programme evaluating single agent therapy with the targeted anti cancer agents, dabrafenib and trametinib, in patients with BRAF V600 mutation positive metastatic melanoma were presented today at the Annual Meeting of the American Society of Clinical Oncology in Chicago. The Phase III data for trametinib were also published online today in the New England Journal of Medicine.

    Both the BREAK3 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 or OS) than those who received chemotherapy with dacarbazine. OS data are not yet mature in the BREAK3 trial.

    “The results from the clinical studies of dabrafenib and trametinib presented at this meeting represent important progress towards understanding how these investigational agents could benefit patients with advanced and metastatic melanoma. Importantly, trametinib is the first MEK inhibitor to demonstrate clinical benefit in a late phase melanoma trial.” said Dr. Rafael Amado, Head of Oncology R&D for GlaxoSmithKline. “We are planning regulatory submissions for dabrafenib and trametinib as single agent therapies and have recently started a Phase III programme to further investigate the effect of the combination in this disease.”

    The BREAK3 study enrolled patients with previously untreated BRAF V600E mutation positive metastatic melanoma and compared dabrafenib to dacarbazine. In this study, dabrafenib treatment reduced the risk of disease progression or death by 70% (Hazard Ratio (HR) 0.30; p

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