Amgen Presents Data From Phase 3 XGEVA Study In Patients With Multiple Myeloma

(RTTNews) - Amgen (AMGN) announced new data from the XGEVA or denosumab Phase 3 '482 study, the largest international multiple myeloma trial ever conducted. The study met its primary endpoint, demonstrating XGEVA is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95 percent CI: 0.85, 1.14; p=0.01).

The analysis demonstrated that patients on XGEVA had a significantly lower rate of renal adverse events compared to zoledronic acid (10.0 percent versus 17.1 percent, p<0.001).

The results presented today showed that in patients with renal insufficiency, defined as having a creatinine clearance (CrCl) of less than or equal to 60 mL/min, the rate of renal adverse events was double in the zoledronic acid arm compared to the XGEVA arm (26.4 percent versus 12.9 percent, respectively). The zoledronic acid label does not recommend treatment in patients with a CrCl of less than 30 mL/min; therefore, patients with severe renal impairment were excluded from this study.1 Median cumulative exposure to XGEVA was 15.75 months compared to 14.78 months for zoledronic acid.

XGEVA is currently indicated for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors and is the number one prescribed agent for this indication in the United States (U.S.). XGEVA is currently not indicated for the prevention of skeletal-related events in patients with multiple myeloma.