Yervoy ipilimumab: Additional Phase III data

Additional data from the double-blind, international Phase III Study 024 trial in 502 patients with previously untreated, unresectable stage III or IV metastatic melanoma showed that 10 mg/kg IV Yervoy plus dacarbazine significantly improved median OS, the primary endpoint, vs. placebo plus dacarbazine (11.2 vs. 9.1 months, p=0.0009). Additionally, Yervoy plus dacarbazine led to higher 1- (47.3% vs. 36.3%), 2- (28.5% vs. 17.9%) and 3-year (20.8% vs. 12.2%) survival rates compared to placebo plus dacarbazine. On secondary endpoints, Yervoy plus dacarbazine significantly improved median duration of response in patients who achieved an objective response vs. placebo plus dacarbazine (19.3 vs. 8.1 months, p=0.03), but non-significantly improved ORR (15.2% vs. 10.3%, p=0.09) and DCR (33.2% vs. 30.2%, p=0.41). Adverse events included elevated alanine and aspartate aminotransferase levels, diarrhea, pruritis and rash. Data were published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology meeting in Chicago. ...