Efficacy and Safety of Ipilimumab Reinduction Therapy Patients with Pretreated Advanced Melanoma Participating in an Expanded Access Programme (EAP) in Italy

ABSTRACT Purpose In the registrational phase III trial of ipilimumab, patients who progressed after initially responding to ipilimumab treatment could subsequently receive additional ipilimumab therapy with the same treatment regimen (reinduction). Here, we describe efficacy and safety data from the Italian subgroup of patients in the EAP who received reinduction with ipilimumab outside of a clinical trial setting. Methods Ipilimumab was available upon physician request for patients aged ≥16 years with life-threatening, unresectable stage III/IV melanoma who failed or did not tolerate previous treatments and for whom no therapeutic option was available. Induction therapy with ipilimumab was 3 mg/kg every 3 weeks for 4 doses. Patients who progressed after stable disease (SD) lasting ≥3 months or an initial partial response (PR) or complete response (CR) were eligible for reinduction therapy at the same dose/schedule. Tumour assessments were conducted at baseline and after completion of induction therapy using immune-related response criteria. Patients were monitored for adverse events (AEs), including immune-related AEs, within 3 to 4 days of each ipilimumab dose using Common Terminology Criteria for Adverse Events v.3.0. Results Of 848 patients participating in the EAP in Italy, 59 received reinduction treatment. After a median follow-up of 10 months, the disease control rate among 26 reinduced patients with data available was 100%; comprising nine patients with a PR and 17 with SD. Overall, only two reinduced patients died as a result of disease progression, after 11 and 13 months. As of April 2012, median overall survival for patients that received reinduction therapy had not yet been reached. In total, 57% patients reported grade 1/2 AEs. Grade 3/4 AEs were reported by 15% patients, but were only considered drug-related in one patient. AEs were generally reversible with treatment as per protocol-specific guidelines. Conclusions Considering available data, reinduction with ipilimumab resulted in durable objective responses and/or stable disease. No new types of toxicities occurred during reinduction and most events were mild-to-moderate. Disclosure P.A. Ascierto: PA has served as a consultant for Merck Sharp u0026 Dohme, and as an advisor to Bristol-Myers Squibb (BMS), Merck Sharp u0026 Dohme, Roche, GlaxoSmithKline, Amgen, Celgene, Medimmune and Novartis. He has received honoraria from BMS, Merck Sharp u0026 Dohme and Roche. P. Queirolo: Paola Queirolo has acted as an advisor for Roche, GlaxoSmithKline, Bristol-Myers Squibb and Schering-Plough and received honoraria from Bristol-Myers Squibb and Roche. M.G. Bernengo: Maria Grazia Bernengo has acted as an advisor to Bristol-Myers Squibb, Novartis and Pfizer. All other authors have declared no conflicts of interest.