Amgen announces positive top-line results from XGEVA® (denosumab) Phase 3 trial for delay of bone complications in multiple myeloma patients.
Amgen 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. The hazard ratio of XGEVA 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 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.
“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,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “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.”
Detailed results will be submitted to a future medical conference and for publication. The Company plans to submit these data to regulatory authorities.
About ‘482 Study (NCT01345019)
The ‘482 study was an international, randomized, double-blind, multicenter trial of XGEVA compared with zoledronic acid in the prevention of bone complications in patients with newly diagnosed multiple myeloma. 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). Secondary endpoints included superiority of XGEVA versus zoledronic acid with respect to time to first on-study SRE and first-and-subsequent on-study SRE and overall survival.The safety and tolerability of XGEVA were also compared with zoledronic acid.
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Filed Under: Drug Discovery