Outcomes of ipilimumab treatment-related adverse events in patients with metastatic melanoma (MM) who received systemic corticosteroids in a phase III trial.

8539 Background: Ipilimumab (ipi) is a fully human monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4 to augment antitumor immune responses. In a phase III trial, ipi at 10 mg/kg plus dacarbazine (DTIC) improved overall survival in previously untreated patients (pts) with MM. In ipi studies, the most common drug-related adverse events (AEs) were immune-related, which were generally reversible using treatment guidelines involving prompt recognition, intervention (corticosteroids, and rarely, alternative immunosuppressive agents), and possible discontinuation of therapy. The purpose of this analysis is to evaluate outcomes of ipi treatment-related AEs with use of systemic corticosteroids. Methods: AEs were reported from the first ipi dose up to 70 days after the last dose. Immune-mediated adverse reactions (imARs) were used to characterize inflammatory AEs in previously untreated pts with MM who received ipi plus DTIC in a phase III trial. This analysis includes the imAR categories of hepatiti...