Nivolumab/Ipilimumab in Advanced Melanoma: Comparison of Dosing Regimens
Posted: Wednesday, April 10, 2019
According to Celeste Lebbé, MD, PhD, of the Hospital Saint Louis in Paris, and colleagues, a regimen of nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg (NIVO3+IPI1) seems to have a superior safety profile than a regimen of nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg (NIVO1+IPI3). A first-line treatment for patients with advanced melanoma, NIVO1+IPI3 is associated with a higher rate of treatment discontinuation than either nivolumab or ipilimumab alone, due to treatment-related adverse effects. The results with this modified dosing regimen, focused on a safety comparison, were published in the Journal of Clinical Oncology.
In this phase III, double-blind, international, multicenter study (CheckMate 511), 360 patients with previously untreated, unresectable, stage III or IV melanoma were randomly assigned to receive NIVO3+IPI1 or NIVO1+IPI3 and then maintenance nivolumab. In total, 66% and 56% of patients completed therapy, respectively.
After a median follow-up of 18.8 and 18.6 months, NIVO3+IPI1 resulted in fewer treatment-related adverse events of grade 3 to grade 5 compared with NIVO1+IPI3 (33.9% vs. 48.3%, P = .006). Consequently, the treatment discontinuation rate was lower in the NIVO3+IPI1 group than in the NIVO1+IPI3 group (16.7% vs. 27.5%, respectively). The authors found no significant differences in terms of overall response rate (45.6% vs. 50.6%), progression-free survival (9.9 vs. 8.9 months), and overall survival (not reached in either group); health-related quality-of-life assessments also did not differ significantly between the groups.
“This study provides important information for health-care providers to consider regarding the benefit/risk profile of anti–PD-1 agents combined with [ipilimumab], particularly in certain populations—such as elderly patients,” concluded the authors.
Disclosure: The study authors’ disclosure information may be found at ascopubs.org.