Combined vemurafenib and cobimetinib in BRAF-mutated melanoma

James Larkin, Paolo A. Ascierto, Brigitte Dréno, Victoria Atkinson, Gabriella Liszkay, Michele Maio, Mario Mandalà, Lev Demidov, Daniil Stroyakovskiy, Luc Thomas, Luis De La Cruz-Merino, Caroline Dutriaux, Claus Garbe, Mika A. Sovak, Ilsung Chang, Nicholas Choong, Stephen P. Hack, Grant A. McArthur, Antoni Ribas

Research output: Contribution to journalArticlepeer-review


Background The combined inhibition of BRAF and MEK is hypothesized to improve clinical outcomes in patients with melanoma by preventing or delaying the onset of resistance observed with BRAF inhibitors alone. This randomized phase 3 study evaluated the combination of the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib.

Methods We randomly assigned 495 patients with previously untreated unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma to receive vemurafenib and cobimetinib (combination group) or vemurafenib and placebo (control group). The primary end point was investigator-assessed progression-free survival.

Results The median progression-free survival was 9.9 months in the combination group and 6.2 months in the control group (hazard ratio for death or disease progression, 0.51; 95% confidence interval [CI], 0.39 to 0.68; P

Original languageEnglish
Pages (from-to)1867-1876
Number of pages10
JournalNew England Journal of Medicine
Issue number20
Publication statusPublished - Nov 13 2014

ASJC Scopus subject areas

  • Medicine(all)


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