Robert, CarolineLong, Georgina V.Brady, BenjaminDutriaux, CarolineDi Giacomo, Anna MariaMortier, LaurentRutkowski, PiotrHassel, Jessica C.McNeil, Catriona M.Kalinka, Ewa AnnaLebbe, CelesteCharles, JulieHernberg, Micaela M.Savage, Kerry J.Chiarion-Sileni, VannaMihalcioiu, CatalinMauch, CorneliaArance, AnaCognetti, FrancescoNy, LarsSchmidt, HenrikSchadendorf, DirkGogas, HelenZoco, JesusRe, SandraAscierto, Paolo A.Atkinson, Victoria2021-01-132021-01-132020-11-20Robert, C, Long, G V, Brady, B, Dutriaux, C, Di Giacomo, A M, Mortier, L, Rutkowski, P, Hassel, J C, McNeil, C M, Kalinka, E A, Lebbe, C, Charles, J, Hernberg, M M, Savage, K J, Chiarion-Sileni, V, Mihalcioiu, C, Mauch, C, Arance, A, Cognetti, F, Ny, L, Schmidt, H, Schadendorf, D, Gogas, H, Zoco, J, Re, S, Ascierto, P A & Atkinson, V 2020, 'Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma', Journal of Clinical Oncology, vol. 38, no. 33. https://doi.org/10.1200/JCO.20.00995http://hdl.handle.net/10138/324446PURPOSEThe 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 METHODSIn 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/m(2) 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.RESULTSPatients 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 = 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.CONCLUSIONResults 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 mono-therapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.12enginfo:eu-repo/semantics/openAccessMETASTATIC MELANOMACOMPLETE RESPONSEPEMBROLIZUMABIPILIMUMABSURVIVALCancersArticleopenAccess6b6aa76e-9b94-4691-b7ef-e36b40f5b771000595708800013