Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma

J. Weber, M. Mandala, M. Del Vecchio, H.J. Gogas, A.M. Arance, C.L. Cowey, S. Dalle, M. Schenker, V. Chiarion-Sileni, I. Marquez-Rodas, J.-J. Grob, M.O. Butler, M.R. Middleton, M. Maio, V. Atkinson, P. Queirolo, R. Gonzalez, R.R. Kudchadkar, M. Smylie, N. MeyerL. Mortier, M.B. Atkins, G.V. Long, S. Bhatia, C. Lebbé, P. Rutkowski, K. Yokota, N. Yamazaki, T.M. Kim, V. De Pril, J. Sabater, A. Qureshi, J. Larkin, P.A. Ascierto

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Abstract

BACKGROUND: Nivolumab and ipilimumab are immune checkpoint inhibitors that have been approved for the treatment of advanced melanoma. In the United States, ipilimumab has also been approved as adjuvant therapy for melanoma on the basis of recurrence- free and overall survival rates that were higher than those with placebo in a phase 3 trial. We wanted to determine the efficacy of nivolumab versus ipilimumab for adjuvant therapy in patients with resected advanced melanoma. METHODS: In this randomized, double-blind, phase 3 trial, we randomly assigned 906 patients (≥15 years of age) who were undergoing complete resection of stage IIIB, IIIC, or IV melanoma to receive an intravenous infusion of either nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks (453 patients) or ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks (453 patients). The patients were treated for a period of up to 1 year or until disease recurrence, a report of unacceptable toxic effects, or withdrawal of consent. The primary end point was recurrence-free survival in the intention-totreat population. RESULTS: At a minimum follow-up of 18 months, the 12-month rate of recurrence-free survival was 70.5% (95% confidence interval [CI], 66.1 to 74.5) in the nivolumab group and 60.8% (95% CI, 56.0 to 65.2) in the ipilimumab group (hazard ratio for disease recurrence or death, 0.65; 97.56% CI, 0.51 to 0.83; P
Original languageEnglish
Pages (from-to)1824-1835
Number of pages12
JournalNew England Journal of Medicine
Volume377
Issue number19
DOIs
Publication statusPublished - Nov 9 2017

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Weber, J., Mandala, M., Del Vecchio, M., Gogas, H. J., Arance, A. M., Cowey, C. L., Dalle, S., Schenker, M., Chiarion-Sileni, V., Marquez-Rodas, I., Grob, J-J., Butler, M. O., Middleton, M. R., Maio, M., Atkinson, V., Queirolo, P., Gonzalez, R., Kudchadkar, R. R., Smylie, M., ... Ascierto, P. A. (2017). Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. New England Journal of Medicine, 377(19), 1824-1835. https://doi.org/10.1056/NEJMoa1709030