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| |  Ipilimumab Benefits Patients With Advanced Melanoma Regardless of Immune-Related Adverse Events: Presented at ASCO By Walter Alexander ORLANDO, Fla -- June 3, 2009 -- Disease control and survival benefits with ipilimumab are observed among patients regardless of whether or not they develop grade >=2 immune-related adverse events (irAEs), researchers stated here at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). Jose Lutzky, MD, Melanoma Program, Mount Sinai Hospital, Miami, Florida, presented results of an analysis assessing the association between irAEs and disease control rate and overall survival in a poster presentation on June 1. The analysis was based on 3 completed phase 2 studies (CA184-008, CA184-022, and CA184-007) in which 287 patients with advanced melanoma received ipilimumab 10 mg/kg every 3 weeks for 4 cycles; eligible patients could continue to receive maintenance ipilimumab every 12 weeks from week 24. All 3 studies enrolled patients with unresectable stage III/IV melanoma. Disease control was defined by combined rates of complete response, partial response, and stable disease according to modified World Health Organization (WHO) criteria. On-study irAEs were reported in 70.4% to 84.2% of patients in the 3 studies, with grade >=2 events reported in 39.4% to 64.9%. The disease control rate across the 3 studies, in patients with grade 0/1 events was 20% to 24% and 34% to 43% in patients with grade >=2 events. The number of patients with disease control was higher among those who experienced events as compared with those who did not, but the disease control rate difference was not statistically different between grade 0/1 versus grade >=2 events. For patients who lived up to day 81 in studies 008 and 022, median overall survival from day 81 was 14.8 months for those with any irAE and 8.21 months for those with no irAE within 12 weeks; median OS was 13.6 months and 11.3 months respectively for those with any grade >=2 irAE and for those with no grade <2 irAE within 12 weeks. In an interview, Dr. Lutzky emphasised that many responses occurred in patients with no irAEs after 12 weeks of treatment. "The take-home is that if a patient has an immune reaction -- that is encouraging -- but if they don't, it's not discouraging." Most common irAEs were colitis, rash, autoimmune hepatitis, and uveitis. "We try to treat these events and keep patients on treatment, because these are the patients who tend to do the best," he added. [Presentation title: Association Between Immune-Related Adverse Events and Disease Control or Overall Survival in Patients (pts) With Advanced Melanoma Treated With 10 mg/kg Ipilimumab in Three Phase II Clinical Trials. Abstract 9034]
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