Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.

Content Provider	Semantic Scholar
Author	Wolchok, Jedd D. Chiarion-Sileni, Vanna González, René Antiga Dr. Rutkowski, Piotr Z. Grob, Jean-Jacques Cowey, Charles Lance Lao, Christopher D. Wagstaff, John Paul Schadendorf, Dirk Ferrucci, Pier Francesco Smylie, Michael G. B. Dummer, Reinhard Hill, Andrew J. Hogg, David Forbes Haanen, John B. A. G. Carlino, Matteo Bechter, Oliver E. Maio, Michele De Jerez, Andrea García Guidoboni, Massimo Mcarthur, Grant Lebbé, Celeste Ascierto, Paolo Antonio Long, Georgina V. Cebon, Jonathan Sosman, Jeffrey A. Postow, Michael A. Callahan, Margaret K. Walker, Dana Rollin, Linda M. Bhore, Rafia Hodi, Frank Stephen Larkin, J. Bradley
Copyright Year	2017
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 ClinicalTrials.gov number, NCT01844505 .).
Starting Page	1345
Ending Page	1356
Page Count	12
File Format	PDF HTM / HTML
Alternate Webpage(s)	http://wp.vcu.edu/hemeoncfellowship/wp-content/uploads/sites/3982/2017/09/Overall-Survival-with-Combined-Nivolumab-and-Ipilimumab-in-Advanced-Melanoma-NEJM-2017.pdf
PubMed reference number	28889792v1
Alternate Webpage(s)	https://doi.org/10.1056/NEJMoa1709684
DOI	10.1056/NEJMoa1709684
Journal	The New England journal of medicine
Volume Number	377
Issue Number	14
Language	English
Access Restriction	Open
Subject Keyword	Adverse reaction to drug CD274 gene CD274 wt Allele Cessation of life Fifty Nine Follow-Up Report Kilogram Ligands Mutation Overall Survival Patients PersonNameUse - assigned Progression-Free Survival ipilimumab melanoma nivolumab
Content Type	Text
Resource Type	Article