Amgen said results were positive from the Phase III '482 clinical trial that evaluated Xgeva (denosumab) versus zoledronic acid in preventing fractures and other skeletal-related issues in patients with multiple myeloma.
"Preventing fractures and other bone complications and preserving renal function are two of the most important aspects to consider when caring for patients with multiple myeloma," Amgen Executive Vice President of Research and Development Sean Harper said in a release. "Up to 40 percent of patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis, underscoring the need for alternative treatment options. We look forward to making Xgeva, a novel treatment option, available to multiple myeloma patients."
Multiple myeloma, a hematologic cancer, develops in the plasma cells in the bone marrow. It causes osteolytic bone lesions. The plasma cells also produce abnormal proteins that can lead to renal failure. The current treatments, including zoledronic acid, are cleared through the kidneys. Xgeva is a monoclonal antibody and is not cleared by the kidneys.
The Phase III trial enrolled 1,718 patients, with 859 participants in each group. The study met its primary endpoint in delaying skeletal-related events during the trial. It also showed that when compared to zoledronic acid, Xgeva had a lower rate of renal adverse events.
"Bone complications in multiple myeloma patients, including fractures, can have a devastating impact on patients," Massachusetts General Hospital Cancer Center, Center for Multiple Myeloma Director Noopur Raje said in the release. "Current treatment options for these complications are limited to bisphosphonates, including zoledronic acid, which are cleared by the kidneys and can be associated with increased renal toxicity. Renal impairment is a common complication in multiple myeloma patients. Denosumab, which is not cleared by the kidneys, may offer a novel, safe and effective option for multiple myeloma patients."
Amgen presented data on the trial at the recent meeti g of the American Society of Clinical Oncology.