Influence of Disease and Patient Characteristics on Daratumumab Exposure and Clinical Outcomes in Relapsed or Refractory Multiple Myeloma

• DOI: 10.1007/s40262-017-0598-1
• Publication Date: 2017-10-05T06:50:19Z
• Authors: Xiaoyu Yan; Pamela L. Clemens; Thomas Puchalski; Sagar Lonial; Henk Lokhorst; Peter M. Voorhees; Saad Usmani; Paul G. Richardson; Torben Plesner; Kevin Liu; Robert Z. Orlowski; Nedjad Losic; Richard Jansson; Tahamtan Ahmadi; Kristen Lantz; Juan Jose Perez R...; Honghui Zhou; Xu Steven Xu
• Keywords: Daratumumab; Refractory (planetary science)

The aim of this study was to understand the influence disease and patient characteristics on exposure daratumumab, an immunoglobulin Gκ (IgGκ) monoclonal antibody, clinical outcomes in relapsed or refractory multiple myeloma (MM). Baseline type, albumin levels, renal/hepatic function, age, sex, race, weight, Eastern Cooperative Oncology Group (ECOG) status, number prior therapies were evaluated using data from two studies—GEN501 (N = 104) SIRIUS 124). Daratumumab clearance approximately 110% higher IgG patients than non-IgG patients, leading significantly lower based maximum trough serum concentrations (p < 0.0001). However, overall response rate similar for (odds ratio 1.08, 95% confidence interval 0.54–2.17, p 0.82). For a given exposure, drug effect (approximately times) versus 0.03). other daratumumab minimal no significant efficacy observed ≥ 0.1). incidences infections grade 3 adverse events subpopulations generally consistent with that population. Due competition MM-produced M-protein neonatal Fc receptor protection clearance, IgG-based antibodies general may have MM compared patients. Careful evaluation impact safety is warranted all used MM.