Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study—Asian Subgroup Analysis

• DOI: 10.1007/s12325-020-01395-x
• Publication Date: 2020-06-10T17:02:38Z
• Authors: Shang-Yi Huang; Sung-Soo Yoon; Kazuyuki Shimizu; Wee Joo Chng; Cheng-Shyong Chang; Raymond Siu-Ming ...; Seasea Gao; Yang Wang; Steve W. Gordon; Anthony Glennane; Chang-Ki Min
• Keywords: Zoledronic Acid; Denosumab; Subgroup analysis

The primary analysis of a global phase 3 study that evaluated the efficacy and safety denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated was noninferior to time first on-study SREs. Here we present subgroup evaluate Asian patients. Patients were randomized 1:1 receive 120 mg subcutaneously or intravenously 4 every weeks double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient either drug until an estimated 676 experienced at least one SRE analyses completed. Of 1718 total enrolled patients, 196 (denosumab, n = 103; acid, 93) included this analysis. Fewer group developed compared group; crude incidence SREs cutoff 38.8% 50.5%, respectively (HR [95% CI], 0.77 [0.48–1.26]). 194 receiving dose treatment-emergent AE. most common AEs reported acid) diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred 9/102 (8.8%) 20/92 (21.7%) respectively. Similar rates positively adjudicated osteonecrosis jaw (7 [6.9%] vs 5 [5.4%]) hypocalcemia (19 [18.6%] 17 [18.5%]) groups, Efficacy outcomes from comparable those full population. Overall, supports as additional treatment option standard care MM lytic bone lesions. ClinicalTrials.gov NCT01345019.