Xgeva: Additional Phase III data

A post hoc subgroup analysis of 846 men with CRPC and a prostate specific antigen (PSA) doubling time of <6 months in the double-blind, international Phase III 20050147 trial showed that 120 mg subcutaneous Xgeva every 4 weeks significantly improved median time to first occurrence of bone metastasis or death from any cause, the primary endpoint, by 7.2 months vs. placebo (25.9 vs. 18.7 months, p=0.0064). Xgeva also significantly improved the endpoint in men with a PSA doubling time of <=10 months vs. placebo (28.4 vs. 22.4 months, p=0.042). Amgen said previous studies have shown that higher PSA and faster PSA doubling times are associated with a higher risk of bone metastases. Data were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. Amgen previously reported data from all 1,432 patients in the trial showing that that Xgeva met the primary endpoint vs. placebo (29.5 vs. 25.2 months, p=0.028) (see BioCentury, Dec. 20, 2010 & May 23, 2011). ...