Ipilimumab in metastatic malignant melanoma: The Irish experience.

Abstract

e19059 Background: Ipilimumab (Ipi) is a potent anti CLA-4 immunotherapy recently shown to improve overall survival (OS) in a phase III study in patients (pts) with previously-treated, unresectable or metastatic malignant melanoma. Ipilimumab (3 mg/kg) has been available on compassionate grounds to pts in Ireland since June 2010. Methods: In this retrospective observational study we examine the Irish experience with ipilimumab specifically regarding patient-factors, treatment toxicity, and outcomes including response rate and survival. Results: Between June 2010 and December 2011, a total of 93 patients received ipilimumab. Data available for analyses was conducted in 46patients. Median age of patients was 56 yrs (ranging 28 – 84). M1c disease was identified in 40 patients (83.3%). Median number of prior lines of chemotherapy is 1 (ranging from 1-4). 22 (47.8%) patients received all four planned induction doses of ipilimumab. All patients received full doses of treatment and on schedule. There are no grade 4 toxicities reported and 13% (n= 6) had grade 3 adverse events. This included renal autoimmune toxicity (n=3), diarrhoea (n=1) elevated AST/ALT (n=1), ocular toxicity (n=1) and skin (n=1). Grade 3 adverse events occurred in 3 patients who received all 4 cycles of Ipilimumab. No intestinal perforations or hypophysitis were noted. There were no drug-related deaths. From available survival follow-up data there are 22 reported deaths. Due to paucity of the data, surrogate marker for response of treatment was expressed as absence of disease progression at the time of assessment. Among the 11 (23.9%) patients who responded to treatment, 45.5% of these patients received 4 cycles of ipilimumab. Conclusions: Ipilimumab was well tolerated with a manageable side effect profile. Response rates to ipilimumab in metastatic melanoma in an Irish population are in keeping with internationally reported figures. Comprehensive survival data will be reported as well as correlation of response with hematologic and biochemical blood tests.