AustralieFrV1, Main, Exploration, bibRecord, 004242

Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma

Identifieur interne : 004242 ( Main/Exploration ); précédent : 004241; suivant : 004243

Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma

Auteurs : James Larkin [Royaume-Uni] ; Paolo A. Ascierto [Italie] ; Brigitte Dreno [Italie] ; Victoria Atkinson [Australie] ; Gabriella Liszkay [Hongrie] ; Michele Maio [Italie] ; Mario Mandala [Italie] ; Lev Demidov [Russie] ; Daniil Stroyakovskiy [Russie] ; Luc Thomas [France] ; Luis De La Cruz-Merino [Espagne] ; Caroline Dutriaux [France] ; Claus Garbe [Allemagne] ; Mika A. Sovak [États-Unis] ; ILSUNG CHANG [États-Unis] ; Nicholas Choong [États-Unis] ; Stephen P. Hack [États-Unis] ; Grant A. Mcarthur [Australie] ; Antoni Ribas [États-Unis]

Source :

The New England journal of medicine [ 0028-4793 ] ; 2014.

RBID : Pascal:14-0265572

Descripteurs français

Pascal (Inist)
- Mélanome malin, Médecine.
Wicri :
- topic : Médecine.

English descriptors

KwdEn :
- Malignant melanoma, Medicine.

Abstract

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<0.001). The rate of complete or partial response in the combination group was 68%, as compared with 45% in the control group (P<0.001), including rates of complete response of 10% in the combination group and 4% in the control group. Progression-free survival as assessed by independent review was similar to investigator-assessed progression-free survival. Interim analyses of overall survival showed 9-month survival rates of 81% (95% CI, 75 to 87) in the combination group and 73% (95% CI, 65 to 80) in the control group. Vemurafenib and cobimetinib was associated with a nonsignificantly higher incidence of adverse events of grade 3 or higher, as compared with vemurafenib and placebo (65% vs. 59%), and there was no significant difference in the rate of study-drug discontinuation. The number of secondary cutaneous cancers decreased with the combination therapy. CONCLUSIONS The addition of cobimetinib to vemurafenib was associated with a significant improvement in progression-free survival among patients with BRAF V600-mutated metastatic melanoma, at the cost of some increase in toxicity.

Affiliations:

Allemagne, Australie, Espagne, France, Hongrie, Italie, Royaume-Uni, Russie, États-Unis
Angleterre, Aquitaine, Bade-Wurtemberg, Californie, District de Tübingen, District fédéral central, Grand Londres, Hongrie centrale, Nouvelle-Aquitaine
Bordeaux, Budapest, Londres, Los Angeles, Moscou, Tübingen

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma</title>
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</affiliation>
</author>
<author><name sortKey="Ilsung Chang" sort="Ilsung Chang" uniqKey="Ilsung Chang" last="Ilsung Chang">ILSUNG CHANG</name>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Genentech</s1>
<s2>South San Francisco, CA</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Genentech</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Choong, Nicholas" sort="Choong, Nicholas" uniqKey="Choong N" first="Nicholas" last="Choong">Nicholas Choong</name>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Genentech</s1>
<s2>South San Francisco, CA</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Genentech</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hack, Stephen P" sort="Hack, Stephen P" uniqKey="Hack S" first="Stephen P." last="Hack">Stephen P. Hack</name>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Genentech</s1>
<s2>South San Francisco, CA</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Genentech</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mcarthur, Grant A" sort="Mcarthur, Grant A" uniqKey="Mcarthur G" first="Grant A." last="Mcarthur">Grant A. Mcarthur</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Peter MacCallum Cancer Centre</s1>
<s2>Melbourne, VIC</s2>
<s3>AUS</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Peter MacCallum Cancer Centre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
<affiliation wicri:level="3"><inist:fA14 i1="16"><s1>Jonsson Comprehensive Cancer Center at the University of California</s1>
<s2>Los Angeles, Los Angeles</s2>
<s3>USA</s3>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Los Angeles</settlement>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Malignant melanoma</term>
<term>Medicine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Mélanome malin</term>
<term>Médecine</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">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<0.001). The rate of complete or partial response in the combination group was 68%, as compared with 45% in the control group (P<0.001), including rates of complete response of 10% in the combination group and 4% in the control group. Progression-free survival as assessed by independent review was similar to investigator-assessed progression-free survival. Interim analyses of overall survival showed 9-month survival rates of 81% (95% CI, 75 to 87) in the combination group and 73% (95% CI, 65 to 80) in the control group. Vemurafenib and cobimetinib was associated with a nonsignificantly higher incidence of adverse events of grade 3 or higher, as compared with vemurafenib and placebo (65% vs. 59%), and there was no significant difference in the rate of study-drug discontinuation. The number of secondary cutaneous cancers decreased with the combination therapy. CONCLUSIONS The addition of cobimetinib to vemurafenib was associated with a significant improvement in progression-free survival among patients with BRAF V600-mutated metastatic melanoma, at the cost of some increase in toxicity.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Espagne</li>
<li>France</li>
<li>Hongrie</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>Russie</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Aquitaine</li>
<li>Bade-Wurtemberg</li>
<li>Californie</li>
<li>District de Tübingen</li>
<li>District fédéral central</li>
<li>Grand Londres</li>
<li>Hongrie centrale</li>
<li>Nouvelle-Aquitaine</li>
</region>
<settlement><li>Bordeaux</li>
<li>Budapest</li>
<li>Londres</li>
<li>Los Angeles</li>
<li>Moscou</li>
<li>Tübingen</li>
</settlement>
</list>
<tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Larkin, James" sort="Larkin, James" uniqKey="Larkin J" first="James" last="Larkin">James Larkin</name>
</region>
</country>
<country name="Italie"><noRegion><name sortKey="Ascierto, Paolo A" sort="Ascierto, Paolo A" uniqKey="Ascierto P" first="Paolo A." last="Ascierto">Paolo A. Ascierto</name>
</noRegion>
<name sortKey="Dreno, Brigitte" sort="Dreno, Brigitte" uniqKey="Dreno B" first="Brigitte" last="Dreno">Brigitte Dreno</name>
<name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name>
<name sortKey="Mandala, Mario" sort="Mandala, Mario" uniqKey="Mandala M" first="Mario" last="Mandala">Mario Mandala</name>
</country>
<country name="Australie"><noRegion><name sortKey="Atkinson, Victoria" sort="Atkinson, Victoria" uniqKey="Atkinson V" first="Victoria" last="Atkinson">Victoria Atkinson</name>
</noRegion>
<name sortKey="Mcarthur, Grant A" sort="Mcarthur, Grant A" uniqKey="Mcarthur G" first="Grant A." last="Mcarthur">Grant A. Mcarthur</name>
</country>
<country name="Hongrie"><region name="Hongrie centrale"><name sortKey="Liszkay, Gabriella" sort="Liszkay, Gabriella" uniqKey="Liszkay G" first="Gabriella" last="Liszkay">Gabriella Liszkay</name>
</region>
</country>
<country name="Russie"><region name="District fédéral central"><name sortKey="Demidov, Lev" sort="Demidov, Lev" uniqKey="Demidov L" first="Lev" last="Demidov">Lev Demidov</name>
</region>
<name sortKey="Stroyakovskiy, Daniil" sort="Stroyakovskiy, Daniil" uniqKey="Stroyakovskiy D" first="Daniil" last="Stroyakovskiy">Daniil Stroyakovskiy</name>
</country>
<country name="France"><noRegion><name sortKey="Thomas, Luc" sort="Thomas, Luc" uniqKey="Thomas L" first="Luc" last="Thomas">Luc Thomas</name>
</noRegion>
<name sortKey="Dutriaux, Caroline" sort="Dutriaux, Caroline" uniqKey="Dutriaux C" first="Caroline" last="Dutriaux">Caroline Dutriaux</name>
</country>
<country name="Espagne"><noRegion><name sortKey="De La Cruz Merino, Luis" sort="De La Cruz Merino, Luis" uniqKey="De La Cruz Merino L" first="Luis" last="De La Cruz-Merino">Luis De La Cruz-Merino</name>
</noRegion>
</country>
<country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name>
</region>
</country>
<country name="États-Unis"><noRegion><name sortKey="Sovak, Mika A" sort="Sovak, Mika A" uniqKey="Sovak M" first="Mika A." last="Sovak">Mika A. Sovak</name>
</noRegion>
<name sortKey="Choong, Nicholas" sort="Choong, Nicholas" uniqKey="Choong N" first="Nicholas" last="Choong">Nicholas Choong</name>
<name sortKey="Hack, Stephen P" sort="Hack, Stephen P" uniqKey="Hack S" first="Stephen P." last="Hack">Stephen P. Hack</name>
<name sortKey="Ilsung Chang" sort="Ilsung Chang" uniqKey="Ilsung Chang" last="Ilsung Chang">ILSUNG CHANG</name>
<name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
</country>
</tree>
</affiliations>
</record>

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Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma

Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma

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