Five-year outcomes with nivolumab in patients with wild-type BRAF advanced melanoma
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 previous...
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
September 30, 2020
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| In: |
Journal of clinical oncology
Year: 2020, Volume: 38, Issue: 33, Pages: 3937-3946 |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO.20.00995 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.20.00995 Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.20.00995 
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| Author Notes: | Caroline Robert, MD, PhD; Georgina V. Long, PhD, MBBS; Benjamin Brady, MD; Caroline Dutriaux, MD, PhD; Anna Maria Di Giacomo, MD, PhD; Laurent Mortier, MD, PhD; Piotr Rutkowski, MD, PhD; Jessica C. Hassel, MD; Catriona M. McNeil, MD; Ewa Anna Kalinka, MD; Céleste Lebbé, MD; Julie Charles, MD, PhD; Micaela M. Hernberg, MD; Kerry J. Savage, MSc, MD; Vanna Chiarion-Sileni, MD; Catalin Mihalcioiu, MD; Cornelia Mauch, MD, PhD; Ana Arance, MD, PhD; Francesco Cognetti, MD; Lars Ny, MD; Henrik Schmidt, MD; Dirk Schadendorf, MD; Helen Gogas, MD, PhD; Jesús Zoco, MS; Sandra Re, MD,MB; Paolo A. Ascierto, MD; and Victoria Atkinson, MD |
| Summary: | 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/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.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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| Item Description: | Gesehen am 29.01.2021 |
| Physical Description: | Online Resource |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO.20.00995 |