Phase III trial of Xgeva (denosumab) meets primary endpoint in skeletal-related event in patients with multiple myeloma- Amgen

Amgen has announced that a Phase III study evaluating Xgeva (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma. The secondary endpoints of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were not met. The hazard ratio of Xgeva versus zoledronic acid for overall survival was 0.90. Adverse events observed in patients treated with Xgeva were generally consistent with the known safety profile of Xgeva. The most common adverse events (greater than 25 percent) in the Xgeva arm of the study were diarrhea and nausea.

In the study, a total of 1,718 patients (859 on each arm) were randomized to receive either subcutaneous Xgeva 120 mg and intravenous placebo every four weeks, or intravenous zoledronic acid 4 mg (adjusted for renal function) and subcutaneous placebo every four weeks. The primary endpoint of the study was non-inferiority of Xgeva versus zoledronic acid with respect to time to first on-study SRE (fracture, radiation to bone, surgery to bone or spinal cord compression). Detailed results will be submitted to a future medical conference and for publication. The Company plans to submit these data to regulatory authorities.