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Title: Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.
Austin Authors: Wolchok, Jedd D;Chiarion-Sileni, Vanna;Gonzalez, Rene;Rutkowski, Piotr;Grob, Jean-Jacques;Cowey, C Lance;Lao, Christopher D;Wagstaff, John;Schadendorf, Dirk;Ferrucci, Pier F;Smylie, Michael;Dummer, Reinhard;Hill, Andrew;Hogg, David;Haanen, John;Carlino, Matteo S;Bechter, Oliver;Maio, Michele;Marquez-Rodas, Ivan;Guidoboni, Massimo;McArthur, Grant;Lebbé, Celeste;Ascierto, Paolo A;Long, Georgina V;Cebon, Jonathan S ;Sosman, Jeffrey;Postow, Michael A;Callahan, Margaret K;Walker, Dana;Rollin, Linda;Bhore, Rafia;Hodi, F Stephen;Larkin, James
Affiliation: Texas Oncology-Baylor Cancer Center, Dallas
Bristol-Myers Squibb, Princeton, NJ
niversity Hospitals Leuven, KU Leuven, Leuven, Belgium
General University Hospital Gregorio Marañón, Madrid
Northwestern University, Chicago
Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York
Oncology Institute of Veneto Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italy
European Institute of Oncology, Milan, Italy
Center for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy
Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy
Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy
University of Michigan, Ann Arbor
the College of Medicine, Swansea University, Swansea, United Kingdom
Royal Marsden NHS Foundation Trust, London, United Kingdom
Department of Dermatology, University of Essen, Essen, Germany
German Cancer Consortium, Heidelberg, Germany
Cross Cancer Institute, Edmonton, AB, Canada
Princess Margaret Cancer Centre, Toronto, Canada
Universitäts Spital, Zurich, Switzerland
Tasman Oncology Research, Southport Gold Coast, QLD
Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, Australia
Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, Australia
Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia
Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia
University of Colorado, Denver
Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland
Aix-Marseille University, Hôpital de la Timone, Marseille, France
Assistance Publique-Hôpitaux de Paris, Dermatology and Centres d'Investigation Clinique, INSERM Unité 976, Hôpital Saint-Louis, Université Paris Diderot, Paris, France
Netherlands Cancer Institute, Amsterdam
Dana-Farber Cancer Institute, Boston
Issue Date: 5-Oct-2017 2017-09-11
Publication information: The New England Journal of Medicine 2017; 377(14): 1345-1356
Abstract: BACKGROUND: Nivolumab combined with ipilimumab resulted in longer progression-free survival and a higher objective response rate than ipilimumab alone in a phase 3 trial involving patients with advanced melanoma. We now report 3-year overall survival outcomes in this trial. METHODS: We randomly assigned, in a 1:1:1 ratio, patients with previously untreated advanced melanoma to receive nivolumab at a dose of 1 mg per kilogram of body weight plus ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses, followed by nivolumab at a dose of 3 mg per kilogram every 2 weeks; nivolumab at a dose of 3 mg per kilogram every 2 weeks plus placebo; or ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses plus placebo, until progression, the occurrence of unacceptable toxic effects, or withdrawal of consent. Randomization was stratified according to programmed death ligand 1 (PD-L1) status, BRAF mutation status, and metastasis stage. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group versus the ipilimumab group. RESULTS: At a minimum follow-up of 36 months, the median overall survival had not been reached in the nivolumab-plus-ipilimumab group and was 37.6 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.55 [P<0.001]; hazard ratio for death with nivolumab vs. ipilimumab, 0.65 [P<0.001]). The overall survival rate at 3 years was 58% in the nivolumab-plus-ipilimumab group and 52% in the nivolumab group, as compared with 34% in the ipilimumab group. The safety profile was unchanged from the initial report. Treatment-related adverse events of grade 3 or 4 occurred in 59% of the patients in the nivolumab-plus-ipilimumab group, in 21% of those in the nivolumab group, and in 28% of those in the ipilimumab group. CONCLUSIONS: Among patients with advanced melanoma, significantly longer overall survival occurred with combination therapy with nivolumab plus ipilimumab or with nivolumab alone than with ipilimumab alone. (Funded by Bristol-Myers Squibb and others; CheckMate 067 number, NCT01844505 .).
DOI: 10.1056/NEJMoa1709684
ORCID: 0000-0002-3898-950X
Journal: The New England Journal of Medicine
PubMed URL: 28889792
Type: Journal Article
Appears in Collections:Journal articles

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