Amgen's Phase 3 clinical trial to assess XGEVA compared to zoledronic acid has achieved its primary goal of proving to delay the time to the first skeletal-related event (SRE) on-study for multiple myeloma patients.
The secondary goals, which included delaying the time to first SRE as well as the first-and subsequent CRE, were not achieved by the trial.
"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," Amgen Executive Vice President of Research and Development Dr. Sean Harper said. "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."
Patients who encountered adverse events, including the most common of diarrhea and nausea, while taking XGEVA proved to be constant with the medication’s safety profile.
Amgen will submit the detailed results of the trial for publication at a forthcoming medical conference and to regulatory authorities.