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 Eggermont; Brigitte Dreno; Keith Nolop; Jiang Li; Betty Nelson; Jeannie Hou; Richard J. Lee; Keith T. Flaherty; Grant A. McArthur

doi:10.1056/NEJMoa1103782

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 journal › Article › peer-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 language	English
Pages (from-to)	2507-2516
Number of pages	9
Journal	New England Journal Of Medicine
Volume	364
Issue number	26
DOIs	https://doi.org/10.1056/NEJMoa1103782
Publication status	Published - 30 Jun 2011

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Chapman, P. B., Hauschild, A., Robert, C., Haanen, J. B., Ascierto, P., Larkin, J., Dummer, R., Garbe, C., Testori, A., Maio, M., Hogg, D., Lorigan, P., Lebbe, C., Jouary, T., Schadendorf, D., Ribas, A., O'Day, S. J., Sosman, J. A., Kirkwood, J. M., ... McArthur, G. A. (2011). Improved survival with vemurafenib in melanoma with BRAF V600E mutation. New England Journal Of Medicine, 364(26), 2507-2516. https://doi.org/10.1056/NEJMoa1103782

@article{6f134d68811a43eca343ee049b169b97,

title = "Improved survival with vemurafenib in melanoma with BRAF V600E mutation",

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",

author = "Chapman, {Paul B.} and Axel Hauschild and Caroline Robert and Haanen, {John B.} and Paolo Ascierto and James Larkin and Reinhard Dummer and Claus Garbe and Alessandro Testori and Michele Maio and David Hogg and Paul Lorigan and Celeste Lebbe and Thomas Jouary and Dirk Schadendorf and Antoni Ribas and O'Day, {Steven J.} and Sosman, {Jeffrey A.} and Kirkwood, {John M.} and Eggermont, {Alexander M M} and Brigitte Dreno and Keith Nolop and Jiang Li and Betty Nelson and Jeannie Hou and Lee, {Richard J.} and Flaherty, {Keith T.} and McArthur, {Grant A.}",

year = "2011",

month = jun,

day = "30",

doi = "10.1056/NEJMoa1103782",

language = "English",

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Chapman, PB, Hauschild, A, Robert, C, Haanen, JB, Ascierto, P, Larkin, J, Dummer, R, Garbe, C, Testori, A, Maio, M, Hogg, D, Lorigan, P, Lebbe, C, Jouary, T, Schadendorf, D, Ribas, A, O'Day, SJ, Sosman, JA, Kirkwood, JM, Eggermont, AMM, Dreno, B, Nolop, K, Li, J, Nelson, B, Hou, J, Lee, RJ, Flaherty, KT & McArthur, GA 2011, 'Improved survival with vemurafenib in melanoma with BRAF V600E mutation', New England Journal Of Medicine, vol. 364, no. 26, pp. 2507-2516. https://doi.org/10.1056/NEJMoa1103782

TY - JOUR

T1 - Improved survival with vemurafenib in melanoma with BRAF V600E mutation

AU - Chapman, Paul B.

AU - Hauschild, Axel

AU - Robert, Caroline

AU - Haanen, John B.

AU - Ascierto, Paolo

AU - Larkin, James

AU - Dummer, Reinhard

AU - Garbe, Claus

AU - Testori, Alessandro

AU - Maio, Michele

AU - Hogg, David

AU - Lorigan, Paul

AU - Lebbe, Celeste

AU - Jouary, Thomas

AU - Schadendorf, Dirk

AU - Ribas, Antoni

AU - O'Day, Steven J.

AU - Sosman, Jeffrey A.

AU - Kirkwood, John M.

AU - Eggermont, Alexander M M

AU - Dreno, Brigitte

AU - Nolop, Keith

AU - Li, Jiang

AU - Nelson, Betty

AU - Hou, Jeannie

AU - Lee, Richard J.

AU - Flaherty, Keith T.

AU - McArthur, Grant A.

PY - 2011/6/30

Y1 - 2011/6/30

N2 - 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

AB - 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

U2 - 10.1056/NEJMoa1103782

DO - 10.1056/NEJMoa1103782

M3 - Article

C2 - 21639808

SN - 1533-4406

VL - 364

SP - 2507

EP - 2516

JO - New England Journal Of Medicine

JF - New England Journal Of Medicine

IS - 26

ER -

Improved survival with vemurafenib in melanoma with BRAF V600E mutation

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