Amgen has announced results from a phase III study of 1,776 advanced cancer patients with different types of solid tumors (not including breast and prostate cancer) or multiple myeloma, which compared Xgeva (denosumab) to Zometa (zoledronic acid) in preventing skeletal-related events (SREs). The study found XGEVA was non-inferior to Zometa in delaying or preventing SREs.
The study was an international, randomized, double-blind, double-dummy, active-controlled study, in which advanced cancer patients with solid tumors or multiple myeloma were randomized to receive either subcutaneous denosumab 120 mg and intravenous placebo (N=886), or Zometa administered intravenously as at least a 15-minute infusion at a dose of 4 mg every four weeks.
Xgeva, a Rank Ligand inhibitor indicated for the prevention of SREs in patients with bone metastases from solid tumors, was approved by the FDA Nov. 18, 2010. Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.