TY - JOUR
TI - Five-year outcomes with nivolumab in patients with wild-type BRAF advanced melanoma
AU - Robert, C.
AU - Long, G.V.
AU - Brady, B.
AU - Dutriaux, C.
AU - Di Giacomo, A.M.
AU - Mortier, L.
AU - Rutkowski, P.
AU - Hassel, J.C.
AU - McNeil, C.M.
AU - Kalinka, E.A.
AU - Lebbé, C.
AU - Charles, J.
AU - Hernberg, M.M.
AU - Savage, K.J.
AU - Chiarion-Sileni, V.
AU - Mihalcioiu, C.
AU - Mauch, C.
AU - Arance, A.
AU - Cognetti, F.
AU - Ny, L.
AU - Schmidt, H.
AU - Schadendorf, D.
AU - Gogas, H.
AU - Zoco, J.
AU - Re, S.
AU - Ascierto, P.A.
AU - Atkinson, V.
JO - Journal of Clinical Oncology
PY - 2020
VL - 38
TODO - 33
SP - 3937-3946
PB - American Society of Clinical Oncology
SN - 0732-183X, 1527-7755
TODO - 10.1200/JCO.20.00995
TODO - 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
TODO - 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
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