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Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma
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 u...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Society of Clinical Oncology
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7676881/ https://www.ncbi.nlm.nih.gov/pubmed/32997575 http://dx.doi.org/10.1200/JCO.20.00995 |
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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 Lebbé, Céleste 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, Jesús Re, Sandra Ascierto, Paolo A. Atkinson, Victoria |
author_facet | 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 Lebbé, Céleste 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, Jesús Re, Sandra Ascierto, Paolo A. Atkinson, Victoria |
author_sort | Robert, Caroline |
collection | PubMed |
description | 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/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. 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. |
format | Online Article Text |
id | pubmed-7676881 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | American Society of Clinical Oncology |
record_format | MEDLINE/PubMed |
spelling | pubmed-76768812021-11-20 Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma 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 Lebbé, Céleste 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, Jesús Re, Sandra Ascierto, Paolo A. Atkinson, Victoria J Clin Oncol Original Reports 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/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. 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. American Society of Clinical Oncology 2020-11-20 2020-09-30 /pmc/articles/PMC7676881/ /pubmed/32997575 http://dx.doi.org/10.1200/JCO.20.00995 Text en © 2020 by American Society of Clinical Oncology https://creativecommons.org/licenses/by-nc-nd/4.0/Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: https://creativecommons.org/licenses/by-nc-nd/4.0/ |
spellingShingle | Original Reports 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 Lebbé, Céleste 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, Jesús Re, Sandra Ascierto, Paolo A. Atkinson, Victoria Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma |
title | Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma |
title_full | Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma |
title_fullStr | Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma |
title_full_unstemmed | Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma |
title_short | Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma |
title_sort | five-year outcomes with nivolumab in patients with wild-type braf advanced melanoma |
topic | Original Reports |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7676881/ https://www.ncbi.nlm.nih.gov/pubmed/32997575 http://dx.doi.org/10.1200/JCO.20.00995 |
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