Journal article

Bayesian Population Model of the Pharmacokinetics of Venetoclax in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase III MURANO Study

Rong Deng, Leonid Gibiansky, Tong Lu, Priya Agarwal, Hao Ding, Xiaobin Li, Smita Kshirsagar, Dan Lu, Chunze Li, Sandhya Girish, Jue Wang, Michelle Boyer, Kathryn Humphrey, Kevin J Freise, Ahmed Hamed Salem, John F Seymour, Arnon P Kater, Dale Miles

Clinical Pharmacokinetics | ADIS INT LTD | Published : 2019

Abstract

BACKGROUND: Venetoclax is a selective B-cell lymphoma-2 (BCL-2) inhibitor approved for use as monotherapy or with rituximab in patients with chronic lymphocytic leukemia (CLL). The objectives of the current analysis of observed data from adult patients randomized to venetoclax-rituximab in the phase III MURANO study were to characterize venetoclax pharmacokinetics (PKs) using a Bayesian approach, evaluate whether a previously developed population PK model for venetoclax can describe the PKs of venetoclax when administered with rituximab, and to determine post hoc estimates of PK parameters for the exposure-response analysis. METHODS: Parameter estimates and uncertainty estimated by a populat..

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Grants

Funding Acknowledgements

Genentech and AbbVie provided financial support for this study.