TY - JOUR
T1 - Five-year outcomes with nivolumab in patients with wild-type BRAF advanced melanoma
AU - Robert, Caroline
AU - Long, Georgina V.
AU - Brady, Benjamin
AU - Dutriaux, Caroline
AU - Di Giacomo, Anna Maria
AU - Mortier, Laurent
AU - Rutkowski, Piotr
AU - Hassel, Jessica C.
AU - McNeil, Catriona M.
AU - Kalinka, Ewa Anna
AU - Lebbé, Céleste
AU - Charles, Julie
AU - Hernberg, Micaela M.
AU - Savage, Kerry J.
AU - Chiarion-Sileni, Vanna
AU - Mihalcioiu, Catalin
AU - Mauch, Cornelia
AU - Arance, Ana
AU - Cognetti, Francesco
AU - Ny, Lars
AU - Schmidt, Henrik
AU - Schadendorf, Dirk
AU - Gogas, Helen
AU - Zoco, Jesús
AU - Re, Sandra
AU - Ascierto, Paolo A.
AU - Atkinson, Victoria
N1 - Funding Information: Supported by Bristol Myers Squibb. Funding Information: We thank the patients who participated in the CheckMate 066 trial and the clinical study teams. We acknowledge ONO Pharmaceutical Company, Ltd (Osaka, Japan), for contributions to nivolumab development and Dako, an Agilent Technologies, Inc company (Santa Clara, CA), for collaborative development of the PD-L1 immunohistochemistry 28-8 pharmDx assay. Professional medical writing and editorial assistance were provided by Melissa Kirk, PhD; Jessica R. Augello, PhD; and Michele Salernitano at Ashfield Healthcare Communications (Lyndhurst, NJ), funded by Bristol Myers Squibb. Publisher Copyright: © 2020 by American Society of Clinical Oncology Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/11/20
Y1 - 2020/11/20
N2 - 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 5 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 monotherapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.
AB - 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 5 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 monotherapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.
U2 - 10.1200/JCO.20.00995
DO - 10.1200/JCO.20.00995
M3 - Article
VL - 38
SP - 3937
EP - 3946
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 33
ER -