Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma

Abstract

BACKGROUND Nivolumab plus ipilimumab or nivolumab alone resulted in longer progression-free and overall survival than ipilimumab alone in a trial involving patients with advanced melanoma. We now report 5-year outcomes in the trial. METHODS We randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared with the ipilimumab group. RESULTS At a minimum follow-up of 60 months, the median overall survival was more than 60.0 months (median not reached) in the nivolumab-plus-ipilimumab group and 36.9 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, 0.52; hazard ratio for death with nivolumab vs. ipilimumab, 0.63). Overall survival at 5 years was 52% in the nivolumab-plus-ipilimumab group and 44% in the nivolumab group, as compared with 26% in the ipilimumab group. No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone. No new late toxic effects were noted. CONCLUSIONS Among patients with advanced melanoma, sustained long-term overall survival at 5 years was observed in a greater percentage of patients who received nivolumab plus ipilimumab or nivolumab alone than in those who received ipilimumab alone, with no apparent loss of quality of life in the patients who received regimens containing nivolumab. (Funded by Bristol-Myers Squibb and others; CheckMate 067 ClinicalTrials.gov number, NCT01844505.). © 2019 Massachusetts Medical Society.

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Affiliated Institutions

• KU Leuven BE
• Odense University Hospital DK
• Université Paris Cité FR
• The Netherlands Cancer Institute NL
• Assistance Publique – Hôpitaux de Paris FR
• Assistance Publique Hôpitaux de Marseille FR
• Texas Oncology US
• Trans Tasman Radiation Oncology Group AU
• Aix-Marseille Université FR
• Swansea University GB
• Istituti di Ricovero e Cura a Carattere Scientifico IT
• See-Spital CH
• Royal Marsden NHS Foundation Trust GB
• Princess Margaret Cancer Centre CA
• Melanoma Institute Australia AU
• Istituto Oncologico Veneto IT
• Peter MacCallum Cancer Centre AU
• German Cancer Research Center DE
• Centro de Investigación Biomédica en Red ES
• Deutschen Konsortium für Translationale Krebsforschung
• Inserm FR
• University of Colorado Cancer Center US
• Bristol-Myers Squibb (United States) US
• European Institute of Oncology IT
• The Maria Sklodowska-Curie National Research Institute of Oncology PL
• University of California, San Diego US
• University of Colorado Denver US
• University of Michigan US
• Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IT
• Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" IT
• Dana-Farber Cancer Institute US
• Cancer Institute (WIA) IN
• The University of Sydney AU
• Cornell University US
• Memorial Sloan Kettering Cancer Center US
• Mater Hospital GB

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