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ASPEN: 5.8-year follow-up of zanubrutinib in patients with WM

By Abhilasha Verma

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Jan 28, 2025

Learning objective: After reading this article, learners will be able to cite a new clinical development in Waldenström’s macroglobulinemia.



Zanubrutinib is a covalent BTK inhibitor that has been approved for adult patients with WM by the EMA and the FDA. ASPEN (NCT03053440) is a phase III, open-label trial of zanubrutinib vs ibrutinib in patients with WM.1 Full details of the study design were previously summarized on the Lymphoma Hub. LTE1, a long-term extension phase, enrolled 75 patients with WM treated with zanubrutinib in the APSEN trial.1 Results were presented at the 66th ASH Annual Meeting and Exposition by D’Sa.1 


Key learnings
At a median follow-up of 5.8 years, the ORR was 96.1% in MYD88mut patients and 84.6% MYD88WT in patients.
The median DoR was 55.7 months and 41.1 months in MYD88mut and MYD88WT patients, respectively. The 60-month event-free PFS rate was 74.8% and 39.3% in MYD88mut and MYD88WTpatients, respectively.
Grade ≥3 TEAEs occurred in 29.2% of patients, with serious TEAEs in 23.6% of patients.
Long-term data from the ASPEN trial demonstrate deep and durable efficacy and tolerable safety profile of zanubrutinib regardless of mutation status, supporting its use in patients with WM.

Abbreviations: BTK, Bruton’s tyrosine kinase inhibitor; DoR, duration of response; EMA, European Medical Agency; FDA, U.S. Food and Drug Administration; LTE1, long-term extension; ORR, overall response rate; PFS, progression-free survival; mut, mutated; TEAE, treatment-emergent adverse event; WM, Waldenstrom’s macroglobulinemia; WT, wild type.

References

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