Denosumab Versus Zoledronic Acid for Treating Myeloma With Bone Disease
Posted: Tuesday, April 3, 2018
The monoclonal antibody denosumab is a potential additional therapeutic option for patients who have multiple myeloma with bone disease, possibly as a standard-of-care treatment choice along with the bisphosphonate zoledronic acid, according to the results of a phase III study published in The Lancet Oncology.
A team led by Noopur Raje, MD, of the Center for Multiple Myeloma at Massachusetts General Hospital Cancer Center in Boston, conducted a double-blind, randomized study to see whether denosumab would be noninferior to zoledronic acid in preventing skeletal-related events (SREs) in 1,718 newly diagnosed patients from 29 countries. SREs commonly occur in patients with multiple myeloma and include spinal cord compression and pathologic fracture.
One patient group (n = 859) received subcutaneous denosumab at 120 mg plus intravenous placebo every 4 weeks, whereas the other group (n = 859) received subcutaneous placebo plus intravenous zoledronic acid at 4 mg every 4 weeks. Both cohorts received investigators’ choice of first-line multiple myeloma therapy.
“The primary endpoint was met: Denosumab was noninferior to zoledronic acid in delaying time to first SRE,” wrote the authors. The median times to the first SRE were 22.8 and 24.0 months in the denosumab and zoledronic acid groups, respectively, and overall survival rates were also similar. Plus, “the lower risk of renal adverse events compared with zoledronic acid makes denosumab an attractive option for patients with multiple myeloma, in whom renal disease is a substantial challenge,” noted Dr. Raje and her colleagues.