Journal article
Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL
CS Tam, J Trotman, S Opat, JA Burger, G Cull, D Gottlieb, R Harrup, PB Johnston, P Marlton, J Munoz, JF Seymour, D Simpson, A Tedeschi, R Elstrom, Y Yu, Z Tang, L Han, J Huang, W Novotny, L Wang Show all
Blood | AMER SOC HEMATOLOGY | Published : 2019
Abstract
Zanubrutinib is a potent and highly selective inhibitor of Bruton tyrosine kinase (BTK). In this first-in-human, open-label, multicenter, phase 1 study, patients in part 1 (3 1 3 dose escalation) had relapsed/refractory B-cell malignancies and received zanubrutinib 40, 80, 160, or 320 mg once daily or 160 mg twice daily. Part 2 (expansion) consisted of disease-specific cohorts, including treatment-naive or relapsed/refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL). The primary end points were safety and tolerability, and definition of the maximum tolerated dose (part 1). Additional end points included pharmacokinetics/pharmacodynamics and preliminary efficacy. Rep..
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Funding Acknowledgements
This work, including medical writing and editorial assistance, was supported by BeiGene USA, Inc.