Oct. 20, 2016
Amgen has announced that a Phase 3 study evaluating XGEVA® (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority (hazard ratio = 0.98, 95 percent CI, 0.85 – 1.14) 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. XGEVA’s hazard ratio versus zoledronic acid for overall survival was 0.90 (95 percent CI, 0.70 – 1.16).
Adverse events observed in patients treated with XGEVA were generally consistent with its known safety profile. Nausea and diarrhea were the most common adverse events (greater than 25 percent) in the XGEVA arm of the study.
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said: “Bone complications like fracture, spinal cord compression and radiation or surgery to bone are devastating for multiple myeloma patients. Many of these patients suffer from renal impairment, which has limited their treatment options. XGEVA’s unique mechanism of action has the potential to prevent bone complications in multiple myeloma patients regardless of their renal status, fulfilling an important unmet medical need.”