The following is a summary of “Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma,” published in the January 2023 issue of Oncology by Weber, et al.
Both ipilimumab and nivolumab demonstrated efficacy as therapeutic agents for high-risk resected melanoma. Nivolumab adjuvant with ipilimumab was compared to nivolumab alone in the phase III CheckMate 915 study for patients with resected stage IIIB-D or IV melanoma.
In the randomized, double-blind, phase III study, 1,833 patients received either nivolumab 480 mg once every four weeks (917 patients) or nivolumab 240 mg once every two weeks with ipilimumab 1 mg/kg once every six weeks (916 patients) for ≤1 year. Following random assignment, patients were divided into groups according to the expression and stage of the tumor’s PD-L1 protein. Recurrence-free survival (RFS) and tumor PD-L1 expression level <1% were the two main endpoints. Patients were randomized at random.
With a minimum follow-up of about 23.7 months, there was no discernible difference in RFS between treatment groups in the population of patients who were all randomly assigned (hazard ratio, 0.92; 95% CI, 0.77 to 1.09; P =.269) or in those who had PD-L1 expression levels <1% (hazard ratio, 0.91; 95% CI, 0.73 to 1.14). RFS rates at 24 months were 64.6% (combination) and 63.2% for all patients (nivolumab). 32.6% of patients in the combination group and 12.8% of patients receiving nivolumab reported experiencing treatment-related grade 3 or 4 adverse events. 0.4% of patients in the combination group and none of the nivolumab-treated individuals experienced treatment-related fatalities.
In patients with stage IIIB-D or stage IV melanoma, nivolumab 240 mg once every two weeks + ipilimumab 1 mg/kg once every six weeks did not improve RFS compared to nivolumab 480 mg once every four weeks. Nivolumab demonstrated effectiveness in line with prior adjuvant trials in a population representative of current practice utilizing the eighth edition of the American Joint Committee on Cancer, reiterating nivolumab as the gold standard for melanoma adjuvant therapy.