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 M M EggermontBrigitte Dreno, Keith Nolop, Jiang Li, Betty Nelson, Jeannie Hou, Richard J. Lee, Keith T. Flaherty, Grant A. McArthur

Research output: Contribution to journalArticlepeer-review

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, response duration, and safety. A final analysis was planned after 196 deaths and an interim analysis after 98 deaths. RESULTS: At 6 months, overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group. In the interim analysis for overall survival and final analysis for progression-free survival, vemurafenib was associated with a relative reduction of 63% in the risk of death and of 74% in the risk of either death or disease progression, as compared with dacarbazine (P

Original languageEnglish
Pages (from-to)2507-2516
Number of pages10
JournalNew England Journal of Medicine
Volume364
Issue number26
DOIs
Publication statusPublished - Jun 30 2011

ASJC Scopus subject areas

  • Medicine(all)

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