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

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  • Caroline Robert, Institut Gustave Roussy, Universite Paris-Saclay
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  • Georgina V. Long, University of Sydney, Royal North Shore and Mater Hospitals
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  • Benjamin Brady, Cabrini Health, Melbourne
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  • Caroline Dutriaux, Hopital Saint-Andre
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  • Anna Maria Di Giacomo, University Hospital of Siena
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  • Laurent Mortier, Université de Lille
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  • Piotr Rutkowski, Maria Sklodowska-Curie Institute of Oncology
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  • Jessica C. Hassel, HIT, University Hospital, Heidelberg
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  • Catriona M. McNeil, Chris O'Brien Lifehouse, Royal Prince Alfred Hospital, Melanoma Institute Australia.
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  • Ewa Anna Kalinka, Polish Mother’s Memorial Hospital-Research Institute
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  • Céleste Lebbé, Hôpital Saint-Louis
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  • Julie Charles, Universite Grenoble Alpes
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  • Micaela M. Hernberg, Helsinki University Hospital
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  • Kerry J. Savage, University of British Columbia
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  • Vanna Chiarion-Sileni, IRCCS Istituto Oncologico Veneto - Padova
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  • Catalin Mihalcioiu, McGill University
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  • Cornelia Mauch, University Hospital Cologne and Centrum für Integrierte Onkologie Köln
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  • Ana Arance, Hospital Clinic de Barcelona
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  • Francesco Cognetti, IRCCS Istituti fisioterapici ospitalieri - Istituto Regina Elena
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  • Lars Ny, University of Gothenburg
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  • Henrik Schmidt
  • Dirk Schadendorf, University Hospital Essen, German Cancer Consortium (DKTK)
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  • Helen Gogas, National and Kapodistrian University of Athens
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  • Jesús Zoco, Syneos Health
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  • Sandra Re, Bristol-Myers Squibb
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  • Paolo A. Ascierto, IRCCS Istituto nazionale tumori Fondazione Giovanni Pascale - Napoli
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  • Victoria Atkinson, Greenslopes Private Hospital

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 = 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 mono-therapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.

Original languageEnglish
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume38
Issue33
Pages (from-to)3937-3946
Number of pages10
ISSN0732-183X
DOIs
Publication statusPublished - Nov 2020

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