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The Journal of Clinical Oncology Publishes Phase 3 XGEVA™ (Denosumab) Results in Advanced Cancer Patients With Solid Tumors or Multiple Myeloma
Date:2/22/2011

th XGEVA was not statistically superior compared to Zometa based upon the statistical testing strategy (adjusted p=0.06) (secondary endpoint). The time to first- and subsequent SRE was also numerically greater but not statistically superior compared to Zometa (hazard ratio 0.90, 95 percent CI: 0.77-1.04, p=0.14) (secondary endpoint).

In a subgroup analysis of patients with multiple myeloma, mortality appeared to be higher for denosumab-treated patients compared to those in the control arm (hazard ratio [95 percent CI] of 2.26 [1.13, 4.50]; n = 180).  The limited number of patients in this subgroup, however, precludes definitive conclusions regarding the effects of XGEVA in multiple myeloma patients.

In the study, hypocalcemia occurred more frequently with XGEVA, while osteonecrosis of the jaw (ONJ) occurred at similar rates in both groups. Acute phase reactions after the first dose occurred more frequently in the Zometa arm, as did renal adverse events and elevation in serum creatinine. No dose adjustments or dose withholding for renal function are required for XGEVA.

Study Design This 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 (or equivalent creatinine clearance-adjusted dose in patients with baseline creatinine clearance less than or equal to 60 mL/min) every four weeks as per the labeled instructions (N=890). All patients were strongly recommended to take daily calcium and vitamin D supplements. The primary endpoint was time to first on-study SRE.

XGEVA Important Safety InformationXGEVA can cause severe hypocalcemia.  Correct pre-existing hypocalcemia prior to XGEVA treatment.  Monitor calcium levels and administ
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SOURCE Amgen
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