Abstract
Zanubrutinib, a highly selective Bruton tyrosine kinase inhibitor, was evaluated in a phase 1/2 study in patients with various B-cell malignancies. In the subgroup of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), zanubrutinib was administered as 160 mg twice daily (n = 14), 320 mg once daily (n = 18), or =160 mg total dose (n = 5). Herein, we report results for patients receiving a total daily dose of 320 mg (N = 32). Median study follow-up was 18.8 months. Eighteen patients discontinued treatment, 10 because of progressive disease and 8 because of adverse events (AEs); 1 AE (peripheral edema) was considered to be related to zanubrutinib treatment. The most common AEs were diarrhea (43.8%), contusion (37.5%), constipation (31.3%), and upper respiratory tract infection (31.3%). Infection was the most commonly reported AE of interest (18.8% of patients experienced grade =3 infection). At least 1 AE of grade =3 was reported in 59.4% of patients; grade =3 AEs that were reported in >2 patients were anemia (12.5%), pneumonia (9.4%), and myalgia (9.4%). Overall response rate was 84%, with 25% achieving a complete response. Median duration of response was 18.5 months. Median progression-free survival (PFS) was 21.1 months. Zanubrutinib was well tolerated and demonstrated activity in patients with R/R MCL. The trial is registered at www.clinicaltrials.gov as #NCT02343120.
DOI
10.1182/bloodadvances.2020004074
Publication Date
2021-06-22
Publication Title
Blood Advances
Volume
5
Issue
12
Publisher
American Society of Hematology
ISSN
2473-9537
Embargo Period
2024-11-19
First Page
2577
Last Page
2585
Recommended Citation
Tam, C., Opat, S., Simpson, D., Cull, G., & et al. (2021) 'Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma', Blood Advances, 5(12), pp. 2577-2585. American Society of Hematology: Available at: https://doi.org/10.1182/bloodadvances.2020004074
