@article{3077511,
    title = "Five-year outcomes with nivolumab in patients with wild-type BRAF advanced melanoma",
    author = "Robert, C. and Long, G.V. and Brady, B. and Dutriaux, C. and Di Giacomo, A.M. and Mortier, L. and Rutkowski, P. and Hassel, J.C. and McNeil, C.M. and Kalinka, E.A. and Lebbé, C. and Charles, J. and Hernberg, M.M. and Savage, K.J. and Chiarion-Sileni, V. and Mihalcioiu, C. and Mauch, C. and Arance, A. and Cognetti, F. and Ny, L. and Schmidt, H. and Schadendorf, D. and Gogas, H. and Zoco, J. and Re, S. and Ascierto, P.A. and Atkinson, V.",
    journal = "Journal of Clinical Oncology",
    year = "2020",
    volume = "38",
    number = "33",
    pages = "3937-3946",
    publisher = "American Society of Clinical Oncology",
    issn = "0732-183X, 1527-7755",
    doi = "10.1200/JCO.20.00995",
    keywords = "amylase;  B Raf kinase;  dacarbazine;  nivolumab;  pembrolizumab;  placebo;  programmed death 1 ligand 1;  triacylglycerol lipase;  alkylating agent;  B Raf kinase;  BRAF protein, human;  dacarbazine;  immunological antineoplastic agent;  nivolumab, adult;  advanced cancer;  adverse event;  amylase blood level;  Article;  cancer immunotherapy;  cancer patient;  cancer staging;  clinical feature;  clinical outcome;  controlled study;  double blind procedure;  drug safety;  drug withdrawal;  fatigue;  follow up;  human;  human tissue;  major clinical study;  melanoma;  monotherapy;  multicenter study;  overall survival;  phase 3 clinical trial;  post treatment survival;  priority journal;  progression free survival;  pruritus;  randomized controlled trial;  treatment duration;  treatment response;  triacylglycerol lipase blood level;  vitiligo;  wild type;  clinical trial;  enzymology;  genetics;  melanoma;  metabolism;  survival rate, Antineoplastic Agents, Alkylating;  Antineoplastic Agents, Immunological;  Dacarbazine;  Humans;  Melanoma;  Nivolumab;  Progression-Free Survival;  Proto-Oncogene Proteins B-raf;  Survival Rate",
    abstract = "PURPOSE The CheckMate 066 trial investigated nivolumab monotherapy as first-line treatment for patients with previously untreated BRAF wild-type advanced melanoma. Five-year results are presented herein. PATIENTS AND METHODS In this multicenter, double-blind, phase III study, 418 patients with previously untreated, unresectable, stage III/IV, wild-type BRAF melanoma were randomly assigned 1:1 to receive nivolumab 3 mg/kg every 2 weeks or dacarbazine 1,000 mg/m2 every 3 weeks. The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. RESULTS Patients were followed for a minimum of 60 months from the last patient randomly assigned (median follow-up, 32.0 months for nivolumab and 10.9 months for dacarbazine). Five-year OS rates were 39% with nivolumab and 17% with dacarbazine; PFS rates were 28% and 3%, respectively. Five-year OS was 38% in patients randomly assigned to dacarbazine who had subsequent therapy, including nivolumab (n 5 37). ORR was 42% with nivolumab and 14% with dacarbazine; among patients alive at 5 years, ORR was 81% and 39%, respectively. Of 42 patients treated with nivolumab who had a complete response (20%), 88% (37 of 42) were alive as of the 5-year analysis. Among 75 nivolumab-treated patients alive and evaluable at the 5-year analysis, 83% had not received subsequent therapy; 23% were still on study treatment, and 60% were treatment free. Safety analyses were similar to the 3-year report. CONCLUSION Results from this 5-year analysis confirm the significant benefit of nivolumab over dacarbazine for all end points and add to the growing body of evidence supporting long-term survival with nivolumab monotherapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies. © 2020 by American Society of Clinical Oncology"
}