Journal article

Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation

Paul B Chapman, Axel Hauschild, Caroline Robert, John B Haanen, Paolo Ascierto, James Larkin, Reinhard Dummer, Claus Garbe, Alessandro Testori, Michele Maio, David Hogg, Paul Lorigan, Celeste Lebbe, Thomas Jouary, Dirk Schadendorf, Antoni Ribas, Steven J O'Day, Jeffrey A Sosman, John M Kirkwood, Alexander MM Eggermont Show all

New England Journal of Medicine | MASSACHUSETTS MEDICAL SOC | Published : 2011

Abstract

BACKGROUND: Phase 1 and 2 clinical trials of the BRAF kinase inhibitor vemurafenib (PLX4032) have shown response rates of more than 50% in patients with metastatic melanoma with the BRAF V600E mutation. METHODS: We conducted a phase 3 randomized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated, metastatic melanoma with the BRAF V600E mutation. Patients were randomly assigned to receive either vemurafenib (960 mg orally twice daily) or dacarbazine (1000 mg per square meter of body-surface area intravenously every 3 weeks). Coprimary end points were rates of overall and progression-free survival. Secondary end points included the response rate, re..

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University of Melbourne Researchers

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Funding Acknowledgements

Supported by Hoffmann-La Roche.Dr. Chapman reports receiving consulting fees, payment for serving on scientific advisory boards, and grant support from Roche and consulting fees from GlaxoSmithKline; Dr. Hauschild, receiving consulting fees from Abraxis/Celgene, AstraZeneca, Bayer, Biovex, Bristol-Myers Squibb, Boehringer Ingleheim, Eisai, GlaxoSmithKline, Merck, Novartis, and Roche, grant support from Bayer and Merck, and lecture fees from Abraxis/Celgene, AstraZeneca, Biovex, Bristol-Myers Squibb, Merck, Novartis, and Roche; Dr. Robert, receiving consulting fees from Roche, Bristol-Myers Squibb, GlaxoSmithKline, and Merck and travel payments from Bristol-Myers Squibb; Dr. Ascierto, serving as a board member for Bristol-Myers Squibb, GlaxoSmithKline, Schering-Plough, Merck, and Roche and lecture fees from Schering-Plough and Merck; Dr. Garbe, receiving consulting fees from Bristol-Myers Squibb, Merck, GlaxoSmithKline, and Philogen, grant support from Bristol-Myers Squibb, Philogen, and Swedish Orphan, and travel payments from Bristol- Myers Squibb, Roche, and Merck; Dr. Maio, serving on advisory boards for Bristol-Myers Squibb and Pfizer and receiving lecture fees from Bristol-Myers Squibb; Dr. Hogg, receiving consulting fees from Roche, GlaxoSmithKline, and Bristol-Myers Squibb and lecture fees from Roche; Dr. Lorigan, receiving consulting fees from Roche and an educational grant from Roche; Dr. Lebbe, serving on paid advisory boards for Roche and Bristol- Myers Squibb and receiving payments for the development of educational presentations and travel payments from Bristol-Myers Squibb; Dr. Jouary, serving on an advisory board for Bristol-Myers Squibb and receiving consulting fees from Bristol-Myers Squibb and Schering-Plough; Dr. Schadendorf, receiving consulting fees from Roche, GlaxoSmithKline, Bristol-Myers Squibb, and Merck, serving on advisory boards for Roche, GlaxoSmithKline, Bristol-Myers Squibb, Merck, and Schering-Plough, receiving grant support from Schering-Plough and Plexxikon, receiving lecture fees from Bristol-Myers Squibb, Merck, Schering-Plough, and Roche, and receiving payment for developing presentations for Bristol-Myers Squibb; Dr. Ribas, receiving consulting fees from Roche/Genentech; Dr. O'Day, receiving consulting fees from Glaxo-SmithKline, receiving consulting fees, grant support, lecture fees, and payment for the development of educational presentations from Bristol-Myers Squibb, and serving as an expert witness in a private lawsuit; Dr. Sosman, receiving grant support from Roche, Millennium, and GlaxoSmithKline and consulting fees from Roche and Millennium; Dr. Kirkwood, serving as a board member for Morphotek and receiving consulting fees from GlaxoSmithKline and Vical, lecture fees from Merck, and payment for the development of educational presentations from Imedex; Dr. Eggermont, receiving consulting fees from Bristol-Myers Squibb, Merck, and GlaxoSmithKline; Dr. Dreno, receiving consulting fees from Roche; Dr. Nolop, being an employee of and having an equity interest in Plexxikon; Mrs. Li and Dr. Lee, being employees of Roche; Miss Nelson and Dr. Hou, being employees of Genentech and having an equity interest in Roche; Dr. Flaherty, receiving consulting fees from GlaxoSmithKline; and Dr. McArthur, receiving grant support from Pfizer. No other potential conflict of interest relevant to this article was reported. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.