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ASPEN: 5.8-year follow-up of zanubrutinib in patients with WM
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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.
- Shirley D’Sa. Long-term clinical outcomes in patients with Waldenström macroglobulinemia (WM) who received zanubrutinib in the phase 3 ASPEN study: A report from the zanubrutinib extension study. Oral abstract #3031. 66th American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 10, 2024; San Deigo, US.
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