Purpose The main objective was to quantify any potential differences in pharmacokinetic (PK) parameters (AUC and C ) max between RTXM83, a proposed rituximab biosimilar, and its reference product, using a population PK model approach. Methods Rituximab PK and PD data were obtained from a randomized, double-blind, phase III clinical study (RTXM83- AC-01-11) in patients with diffuse large B- cell lymphoma (DLBCL) that received 375 mg/m intravenous RTXM83 or its reference product with CHOP regimen, every 3 weeks, for six cycles. Rituximab levels were quantified by Meso Scale Dis- covery assay. PK analysis was performed using NONMEM 7.3.0. The effect of disease and patient covariates on RXTM83 PK was investigated. Model was evaluated using visual predictive check and non-parametric bootstrap. Results In total, 251 DLBCL patients (127 and 124 in RXTM83-CHOP and rituximab-CHOP arms, respectively) and 5341 serum concentrations (2703 for RXTM83 and 2638 for rituximab, respectively) were available for the population PK analysis. The volume of distribution of the central compartment (V ) and clearance of RXTM83 were estimated at 3.19 L and 12.5 mL/h, respectively. Body surface area allowed to explain the interindividual variability for V . A statistical analysis showed that systemic exposure (AUC and C ) of RTXM83
Cancer Chemotherapy and Pharmacology – Springer Journals
Published: Jan 24, 2018
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