Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma.
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Weber Jeffrey, Mandala Mario, Del Vecchio Michele, Gogas Helen J, Arance Ana M, Cowey C Lance, Dalle Stéphane, Schenker Michael, Chiarion-Sileni Vanna, Marquez-Rodas Ivan, Grob Jean-Jacques, Butler Marcus O, Middleton Mark R, Maio Michele, Atkinson Victoria, Queirolo Paola, Gonzalez Rene, Kudchadkar Ragini R, Smylie Michael, Meyer Nicolas, Mortier Laurent, Atkins Michael B, Long Georgina V, Bhatia Shailender, Lebbé Celeste, Rutkowski Piotr, Yokota Kenji, Yamazaki Naoya, Kim Tae M, de Pril Veerle, Sabater Javier, Qureshi Anila, Larkin James, Ascierto Paolo A, CheckMate 238 Collaborators
Аннотация
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-to-treat 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<0.001). Treatment-related grade 3 or 4 adverse events were reported in 14.4% of the patients in the nivolumab group and in 45.9% of those in the ipilimumab group; treatment was discontinued because of any adverse event in 9.7% and 42.6% of the patients, respectively. Two deaths (0.4%) related to toxic effects were reported in the ipilimumab group more than 100 days after treatment.
CONCLUSIONS: Among patients undergoing resection of stage IIIB, IIIC, or IV melanoma, adjuvant therapy with nivolumab resulted in significantly longer recurrence-free survival and a lower rate of grade 3 or 4 adverse events than adjuvant therapy with ipilimumab. (Funded by Bristol-Myers Squibb and Ono Pharmaceutical; CheckMate 238 ClinicalTrials.gov number, NCT02388906 ; Eudra-CT number, 2014-002351-26 .).