coBRIM: a phase 3, double-blind, placebo-controlled study of vemurafenib versus vemurafenib + cobimetinib in previously
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ORAL PRESENTATION
Open Access
coBRIM: a phase 3, double-blind, placebocontrolled study of vemurafenib versus vemurafenib + cobimetinib in previously untreated BRAFV600 mutation–positive patients with unresectable locally advanced or metastatic melanoma (NCT01689519) Paolo A Ascierto1*, Grant A McArthur2, Brigitte Dréno3, James Larkin4, Gabriella Liszkay5, Michele Maio6, Mario Mandala7, Lev Demidov8, Daniil Stroyakovskiy9, Luc Thomas10, Luis de la Cruz-Merino11, Victoria Atkinson12, Caroline Dutriaux13, Claus Garbe14, Ilsung Chang15, Stephen P. Hack15, Antoni Ribas16 From Melanoma Bridge Meeting 2014 Naples, Italy. 03-06 December 2014 Background Combined inhibition of BRAF and MEK is hypothesized to improve clinical outcomes by preventing or delaying 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. Materials and methods 495 patients were randomly assigned to receive vemurafenib + cobimetinib (60 mg QD, 21 days on/7 days off) or vemurafenib (960 mg BID) + placebo. Eligibility included treatment-naive BRAFV600 mutation–positive patients with unresectable locally advanced or metastatic melanoma and adequate performance status and organ function. The primary end point was investigatorassessed progression-free survival (PFS). Safety monitoring included serial cardiac and ophthalmic evaluation and measurement of creatine phosphokinase. Results Median PFS was 9.9 months with the combination compared with 6.2 months with the control (HR, 0.51; 95% CI, 0.39-0.68; P
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