Robert, Caroline ORCID: 0000-0002-9493-0238, 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. and Atkinson, Victoria (2020). Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma. J. Clin. Oncol., 38 (33). ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Robert, CarolineUNSPECIFIEDorcid.org/0000-0002-9493-0238UNSPECIFIED
Long, Georgina V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brady, BenjaminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dutriaux, CarolineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Di Giacomo, Anna MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mortier, LaurentUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rutkowski, PiotrUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hassel, Jessica C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
McNeil, Catriona M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kalinka, Ewa AnnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lebbe, CelesteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Charles, JulieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hernberg, Micaela M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Savage, Kerry J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chiarion-Sileni, VannaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mihalcioiu, CatalinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mauch, CorneliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Arance, AnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cognetti, FrancescoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ny, LarsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, HenrikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schadendorf, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gogas, HelenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zoco, JesusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Re, SandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ascierto, Paolo A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Atkinson, VictoriaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-310990
DOI: 10.1200/JCO.20.00995
Journal or Publication Title: J. Clin. Oncol.
Volume: 38
Number: 33
Date: 2020
Publisher: AMER SOC CLINICAL ONCOLOGY
Place of Publication: ALEXANDRIA
ISSN: 1527-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
METASTATIC MELANOMA; COMPLETE RESPONSE; PEMBROLIZUMAB; IPILIMUMAB; SURVIVALMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/31099

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