Amgen (AMGN) Announces XGEVA vs. Zoledronic Acid Study Met Primary Endpoint; Secondary Endpoints Missed
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Amgen Announces Positive Top-Line Results From XGEVA® (Denosumab) Phase 3 Trial For Delay Of Bone Complications In Multiple Myeloma Patients
October 20, 2016 4:19 PM EDTTHOUSAND OAKS, Calif., Oct. 20, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today 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... More
