Dabrafenib in BRAF-mutated metastatic melanoma: A multicentre, open-label, phase 3 randomised controlled trial

Axel Hauschild, Jean Jacques Grob, Lev V. Demidov, Thomas Jouary, Ralf Gutzmer, Michael Millward, Piotr Rutkowski, Christian U. Blank, Wilson H. Miller, Eckhart Kaempgen, Salvador Martín-Algarra, Boguslawa Karaszewska, Cornelia Mauch, Vanna Chiarion-Sileni, Anne Marie Martin, Suzanne Swann, Patricia Haney, Beloo Mirakhur, Mary E. Guckert, Vicki GoodmanPaul B. Chapman

Research output: Contribution to journalArticlepeer-review


Background Dabrafenib, an inhibitor of mutated BRAF, has clinical activity with a manageable safety profile in studies of phase 1 and 2 in patients with BRAFV600-mutated metastatic melanoma. We studied the efficacy of dabrafenib in patients with BRAFV600E-mutated metastatic melanoma. Methods We enrolled patients in this open-label phase 3 trial between Dec 23, 2010, and Sept 1, 2011. This report is based on a data cutoff date of Dec 19, 2011. Patients aged 18 years or older with previously untreated, stage IV or unresectable stage III BRAFV600E mutation-positive melanoma were randomly assigned (3:1) to receive dabrafenib (150 mg twice daily, orally) or dacarbazine (1000 mg/m2 intravenously every 3 weeks). Patients were stratified according to American Joint Committee on Cancer stage (unresectable III+IVM1a+IVM1b vs IVM1c). The primary endpoint was investigator-assessed progression-free survival and was analysed by intention to treat; safety was assessed per protocol. This study is registered with ClinicalTrials.gov, number NCT01227889. Findings Of the 733 patients screened, 250 were randomly assigned to receive either dabrafenib (187 patients) or dacarbazine (63 patients). Median progression-free survival was 5 1 months for dabrafenib and 2 7 months for dacarbazine, with a hazard ratio (HR) of 0 30 (95% CI 0 18-0 51; p

Original languageEnglish
Pages (from-to)358-365
Number of pages8
Issue number9839
Publication statusPublished - Jul 2012

ASJC Scopus subject areas

  • Medicine(all)


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