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Denosumab Versus Zoledronic Acid for Myeloma-Related Bone Disease

By: Sarah Campen, PharmD
Posted: Friday, September 4, 2020

Denosumab appears to be an effective alternative treatment option to zoledronic acid in the care of Asian patients with newly diagnosed multiple myeloma (MM) and osteolytic lesions, according to the Asian subgroup analysis of a global phase III study. Chang-Ki Min, MD, PhD, of Seoul St. Mary’s Hospital, Seoul, Korea, and colleagues found that fewer Asian patients in the denosumab group developed first on-study skeletal-related events compared with those in the zoledronic acid group, consistent with results from the full study population. Their findings were published in Advances in Therapy.

Of the 1,718 patients enrolled in the double-blind trial, 196 Asian patients were included in the subgroup analysis. Patients were randomly assigned 1:1 to receive denosumab subcutaneously at 120 mg (n = 103) or zoledronic acid intravenously at 4 mg (n = 93) every 4 weeks. All patients also received standard-of-care first line antimyeloma treatment.

The rate of first on-study skeletal-related events in Asian patients was lower in the denosumab group than in the zoledronic acid group; the crude incidence of skeletal-related events at the primary analysis cutoff was 38.8% versus 50.5%, respectively. The median progression-free survival was 29.7 months in the denosumab group and 30.2 months in the zoledronic acid group (P = .26).

Treatment-emergent adverse events were reported in all 194 patients who received at least one dose of the study drug. The most common adverse events reported in the denosumab and zoledronic acid groups were diarrhea (51.0% and 51.1%), nausea (42.2% and 46.7%), and pyrexia (38.2% and 41.3%). Treatment-emergent renal toxicity occurred in 8.8% and 21.7% of patients, respectively. Similar rates of osteonecrosis of the jaw and treatment-emergent hypocalcemia were reported in both groups.

Disclosure: For full disclosures of the study authors, visit

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