1149 - Ipilimumab for Advanced Melanoma in an Expanded Access Programme (EAP): Ocular, Mucosal and Acral Subtype UK Experience

Abstract

ABSTRACT Background Ipilimumab (Ipi) is a fully human monoclonal antibody against CTLA-4 which acts to promote an anti-tumour immune response. Previous phase III randomised controlled trials showing improved overall survival (OS) in metastatic or unresectable cutaneous melanoma excluded those of ocular (OM) or mucosal (MuM) origin and provided no data for acral melanoma (AM). These patients (pts) were permitted Ipi treatment in the setting of the EAP. Participating UK centres were asked to report data relating to the outcome of Ipi treatment in pts with rare melanoma types. Methods Patients with unresectable stage III/IV disease were treated within the Ipi EAP protocol at an induction dose of 3mg/kg for up to 4 cycles. RECIST criteria were used for response assessment at baseline, 12 weeks and every 12 weeks thereafter. Documentation of adverse events (AEs) and immune-related AEs (ir-AEs) was according to CTCAE v3.0. Results 27 pts; 18 ocular (66%), 5 acral (19%) and 4 mucosal (15%); received at least one cycle of Ipi across 8 UK centres. All had previously received one or more lines of therapy for their disease. Two pts (40%) with AM had a partial response (PR), with a median duration of response of 22 wks (range: 20-24).One pt (25%) with MuM and 3 pts (17%) with OM had stable disease (SD), with a further OM pt demonstrating a mixed response. The median progression free survival (PFS) was 12 wks for the single MuM case and 14.5 wks (range: 6-64) in OM. 5 episodes of G3 ir-AEs were reported in 4 pts (3 colitis, 2 hepatitis), and 2 G3/4 AEs of fatigue. These resolved on steroid therapy. Conclusion Partial responses were seen in metastatic acral but not mucosal or ocular melanoma in this setting. Given the small sample size it is difficult to accurately interpret outcome data. Activity of ipilimumab in rare melanoma subtypes needs to be assessed in prospective studies. Disclosure J. Larkin: I have received honoraria from BMS. P. Corrie: I have undertaken consultancy work and advisory Boards for BMS. J. Nobes: I have been sponsored by BMS to attend conferences. E. Marshall: I have received previous honoraria for serving on an advisory board for BMS. S. Kumar: I have served on the advisory board for BMS. R. Plummer: I have received honoraria for advisory boards to BMS. P. Nathan: I have received compensation for advisory board and speakers panel from BMS. All other authors have declared no conflicts of interest.