New research published in The Lancet Oncology found that denosumab was noninferior to zoledronic acid for time to skeletal-related events in patients with newly diagnosed multiple myeloma.
Monoclonal paraprotein production and osteolytic lesions resulting from multiple myeloma often lead to skeletal-related issues, such as spinal cord compression or pathological fracture. New research published in The Lancet Oncology found that denosumab (Xgeva) was noninferior to zoledronic acid for time to skeletal-related events in patients with newly diagnosed multiple myeloma.
FDA approved denosumab for the prevention of skeletal-related events in patients with multiple myeloma in January.
The study included 1718 patients in an international, double-blinded, double-dummy, randomized, active-controlled phase 3 study in 259 centers in 29 countries. The patients were randomly assigned 1:1 to receive either subcutaneous denosumab 120 mg plus intravenous placebo every 4 weeks or intravenous zoledronic acid 4 mg plus subcutaneous placebo every 4 weeks.
“Until recently, treatment options for the prevention of skeletal-related events in multiple myeloma were limited to bisphosphonates, which are cleared through the kidneys and can be associated with increased renal impairment,” lead study author Noopur Raje, MD, director of the Center for Multiple Myeloma at Massachusetts General Hospital Cancer Center, said in a press release. “Denosumab, which is not cleared through the kidneys, provides a new treatment option for the prevention of skeletal-related events in patients with multiple myeloma.”
In the trial, the median time to first skeletal-related event was 22.8 months for patients on denosumab compared with 24 months for patients receiving zoledronic acid. The most common grade 3 or worse adverse events, occurring at similar rates, for both treatments were neutropenia, thrombocytopenia, anemia, febrile neutropenia, and pneumonia.
There were fewer reported incidents of renal toxicity reported in the denosumab group (10%) compared with the zoldronic acid group (17%), but more hypocalcaemia adverse events (17% versus 12%).
“The results from this study suggest denosumab could be an additional option for the standard of care for patients with multiple myeloma with bone disease,” the authors concluded.
Raje N, Terpos E, Willenbacher W, et al. Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study. Lancet Oncol. doi/10.1016/ S1470-2045(18)30072-X. Published online February 9, 2018. Accessed on February 15, 2018.