Journal article

A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia: the ASPEN study

Constantine S Tam, Stephen Opat, Shirley D'Sa, Wojciech Jurczak, Hui-Peng Lee, Gavin Cull, Roger G Owen, Paula Marlton, Bjorn E Wahlin, Ramon Garcia Sanz, Helen McCarthy, Stephen Mulligan, Alessandra Tedeschi, Jorge J Castillo, Jaroslaw Czyz, Carlos Fernandez de Larrea, David Belada, Edward Libby, Jeffrey Matous, Marina Motta Show all

Blood | AMER SOC HEMATOLOGY | Published : 2020

Abstract

Bruton tyrosine kinase (BTK) inhibition is an effective treatment approach for patients with Waldenström macroglobulinemia (WM). The phase 3 ASPEN study compared the efficacy and safety of ibrutinib, a first-generation BTK inhibitor, with zanubrutinib, a novel highly selective BTK inhibitor, in patients with WM. Patients with MYD88L265P disease were randomly assigned 1:1 to treatment with ibrutinib or zanubrutinib. The primary end point was the proportion of patients achieving a complete response (CR) or a very good partial response (VGPR) by independent review. Key secondary end points included major response rate (MRR), progression-free survival (PFS), duration of response (DOR), disease b..

View full abstract

Grants

Funding Acknowledgements

The authors thank the patients who participated in the study, their supporters, and the investigators and clinical research staff from the study centers. This study was supported by research funding from BeiGene Inc, US medical writing and editorial assistance were funded by BeiGene and provided by Gordon Bray and Alessandra Richardson (Bio Connections, LLC). The study sponsor confirmed the accuracy of the data and compiled the data for analysis.