Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma

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Robert , 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 .

Title: Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma
Author: Robert, Caroline; Long, Georgina V.; Brady, Benjamin; Dutriaux, Caroline; Di Giacomo, Anna Maria; Mortier, Laurent; Rutkowski, Piotr; Hassel, Jessica C.; McNeil, Catriona M.; Kalinka, Ewa Anna; Lebbe, Celeste; Charles, Julie; Hernberg, Micaela M.; Savage, Kerry J.; Chiarion-Sileni, Vanna; Mihalcioiu, Catalin; Mauch, Cornelia; Arance, Ana; Cognetti, Francesco; Ny, Lars; Schmidt, Henrik; Schadendorf, Dirk; Gogas, Helen; Zoco, Jesus; Re, Sandra; Ascierto, Paolo A.; Atkinson, Victoria
Contributor: University of Helsinki, HUS Comprehensive Cancer Center
Date: 2020-11-20
Language: eng
Number of pages: 12
Belongs to series: Journal of Clinical Oncology
ISSN: 0732-183X
Abstract: PURPOSEThe 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.
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