TY - JOUR
T1 - Adjuvant Therapy of Nivolumab Combined with Ipilimumab Versus Nivolumab Alone in Patients with Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915)
AU - Weber, Jeffrey S.
AU - Schadendorf, Dirk
AU - Del Vecchio, Michele
AU - Larkin, James
AU - Atkinson, Victoria
AU - Schenker, Michael
AU - Pigozzo, Jacopo
AU - Gogas, Helen
AU - Dalle, Stéphane
AU - Meyer, Nicolas
AU - Ascierto, Paolo A.
AU - Sandhu, Shahneen
AU - Eigentler, Thomas
AU - Gutzmer, Ralf
AU - Hassel, Jessica C.
AU - Robert, Caroline
AU - Carlino, Matteo S.
AU - Di Giacomo, Anna Maria
AU - Butler, Marcus O.
AU - Muñoz-Couselo, Eva
AU - Brown, Michael P.
AU - Rutkowski, Piotr
AU - Haydon, Andrew
AU - Grob, Jean Jacques
AU - Schachter, Jacob
AU - Queirolo, Paola
AU - De La Cruz-Merino, Luis
AU - Van Der Westhuizen, Andre
AU - Menzies, Alexander M.
AU - Re, Sandra
AU - Bas, Tuba
AU - De Pril, Veerle
AU - Braverman, Julia
AU - Tenney, Daniel J.
AU - Tang, Hao
AU - Long, Georgina V.
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/1/20
Y1 - 2023/1/20
N2 - PURPOSEIpilimumab and nivolumab have each shown treatment benefit for high-risk resected melanoma. The phase III CheckMate 915 trial evaluated adjuvant nivolumab plus ipilimumab versus nivolumab alone in patients with resected stage IIIB-D or IV melanoma.PATIENTS AND METHODSIn this randomized, double-blind, phase III trial, 1,833 patients received nivolumab 240 mg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks (916 patients) or nivolumab 480 mg once every 4 weeks (917 patients) for ≤ 1 year. After random assignment, patients were stratified by tumor programmed death ligand 1 (PD-L1) expression and stage. Dual primary end points were recurrence-free survival (RFS) in randomly assigned patients and in the tumor PD-L1 expression-level < 1% subgroup.RESULTSAt a minimum follow-up of approximately 23.7 months, there was no significant difference between treatment groups for RFS in the all-randomly assigned patient population (hazard ratio, 0.92; 95% CI, 0.77 to 1.09; P =.269) or in patients with PD-L1 expression < 1% (hazard ratio, 0.91; 95% CI, 0.73 to 1.14). In all patients, 24-month RFS rates were 64.6% (combination) and 63.2% (nivolumab). Treatment-related grade 3 or 4 adverse events were reported in 32.6% of patients in the combination group and 12.8% in the nivolumab group. Treatment-related deaths were reported in 0.4% of patients in the combination group and in no nivolumab-treated patients.CONCLUSIONNivolumab 240 mg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks did not improve RFS versus nivolumab 480 mg once every 4 weeks in patients with stage IIIB-D or stage IV melanoma. Nivolumab showed efficacy consistent with previous adjuvant studies in a population resembling current practice using American Joint Committee on Cancer eighth edition, reaffirming nivolumab as a standard of care for melanoma adjuvant treatment.
AB - PURPOSEIpilimumab and nivolumab have each shown treatment benefit for high-risk resected melanoma. The phase III CheckMate 915 trial evaluated adjuvant nivolumab plus ipilimumab versus nivolumab alone in patients with resected stage IIIB-D or IV melanoma.PATIENTS AND METHODSIn this randomized, double-blind, phase III trial, 1,833 patients received nivolumab 240 mg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks (916 patients) or nivolumab 480 mg once every 4 weeks (917 patients) for ≤ 1 year. After random assignment, patients were stratified by tumor programmed death ligand 1 (PD-L1) expression and stage. Dual primary end points were recurrence-free survival (RFS) in randomly assigned patients and in the tumor PD-L1 expression-level < 1% subgroup.RESULTSAt a minimum follow-up of approximately 23.7 months, there was no significant difference between treatment groups for RFS in the all-randomly assigned patient population (hazard ratio, 0.92; 95% CI, 0.77 to 1.09; P =.269) or in patients with PD-L1 expression < 1% (hazard ratio, 0.91; 95% CI, 0.73 to 1.14). In all patients, 24-month RFS rates were 64.6% (combination) and 63.2% (nivolumab). Treatment-related grade 3 or 4 adverse events were reported in 32.6% of patients in the combination group and 12.8% in the nivolumab group. Treatment-related deaths were reported in 0.4% of patients in the combination group and in no nivolumab-treated patients.CONCLUSIONNivolumab 240 mg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks did not improve RFS versus nivolumab 480 mg once every 4 weeks in patients with stage IIIB-D or stage IV melanoma. Nivolumab showed efficacy consistent with previous adjuvant studies in a population resembling current practice using American Joint Committee on Cancer eighth edition, reaffirming nivolumab as a standard of care for melanoma adjuvant treatment.
UR - http://www.scopus.com/inward/record.url?scp=85143235746&partnerID=8YFLogxK
U2 - 10.1200/JCO.22.00533
DO - 10.1200/JCO.22.00533
M3 - Article
C2 - 36162037
AN - SCOPUS:85143235746
SN - 0732-183X
VL - 41
SP - 517
EP - 527
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 3
ER -