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Zanubrutinib is a covalent Bruton tyrosine kinase inhibitor that has been approved for adult patients with Waldenström Macroglobulinemia (WM) by the European Medical Agency and the U.S. Food and Drug Administration. Although the ASPEN (NCT03053440) trial did not meet its primary end point at a median follow-up of 19.4 months, zanubrutinib did exhibit encouraging safety and efficacy data compared to ibrutinib. The Lymphoma Hub is pleased to summarize the recently published long-term efficacy and safety analyses of zanubrutinib versus ibrutinib from the ASPEN trial.
This is a phase III, open-label trial of zanubrutinib versus ibrutinib in patients with WM. Full details of the study design were previously summarized on the Lymphoma Hub. Eligible patients:
Patients with 88-mutant WM were assigned to cohort 1 and those with 88-wild type WM were assigned to cohort 2. The primary endpoint was very good partial response (VGPR) plus complete response (CR) rates. Other endpoints included progression-free survival, overall survival (OS), and safety.
In cohort 1, 99 patients were assigned to ibrutinib and 102 to zanubrutinib and in cohort 2, 28 patients were assigned to zanubrutinib. After 2-year follow-up:
Figure 1. VGPR rates over 5 years*
VGPR, very good partial response.
*Adapted from Dimopoulos, et al.1
Figure 2. Adverse events of interest reported 0-12 months (A) and >36 months after treatment initiation (B) in patients with zanubrutinib versus ibrutinib*
*Adapted from Dimopoulos, et al.1
Extended follow-up results show that treatment with zanubrutinib remained more efficacious than ibrutinib in the long term when comparing VGPR and CR rates. Safety and tolerability of zanubrutinib were comparable to initial results, supporting its use over ibrutinib in patients with WM, regardless of previous treatment or MYD88 mutational status.
‘The International Waldenstrom's Macroglobulinemia Foundation (IWMF) and the Lymphoma Hub are working in collaboration for patients with Waldenstrom's macroglobulinemia. This initiative aims to increase awareness of Waldenstrom's macroglobulinemia among healthcare professionals, patients, caregivers, and the patient advocacy community.
This initiative is funded by Cellectar Biosciences, BeiGene and Eli Lilly. All content is developed independently by SES in collaboration with an expert steering committee; funders are allowed no direct influence on the content of the hub.’
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