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Cited by 466

The DOI matches its Crossref record; 31 of the 31 references it cites were found in a registry or an index.

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

Open access
Tam, Constantine S., Opat, Stephen, D'Sa, Shirley, Jurczak, Wojciech, Lee, Hui-Peng, Cull, Gavin, Owen, Roger G., Marlton, Paula, Wahlin, Björn E., Sanz, Ramón Garcia, McCarthy, Helen, Mulligan, Stephen, Tedeschi, Alessandra, Castillo, Jorge J., Czyz, Jaroslaw, Fernández de Larrea, Carlos, Belada, David, Libby, Edward, Matous, Jeffrey V., Motta, Marina, Siddiqi, Tanya, Tani, Monica, Trneny, Marek, Minnema, Monique C., Buske, Christian, Leblond, Veronique, Trotman, Judith, Chan, Wai Y., Schneider, Jingjing, Ro, Sunhee, Cohen, Aileen, Huang, Jane, Dimopoulos, Meletios·2020·Blood
DOI 10.1182/blood.2020006844
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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 burden, and safety. A total of 201 patients were randomized, and 199 received ≥1 dose of study treatment. No patient achieved a CR. Twenty-nine (28%) zanubrutinib patients and 19 (19%) ibrutinib patients achieved a VGPR, a nonstatistically significant difference (P = .09). MRRs were 77% and 78%, respectively. Median DOR and PFS were not reached; 84% and 85% of ibrutinib and zanubrutinib patients were progression free at 18 months. Atrial fibrillation, contusion, diarrhea, peripheral edema, hemorrhage, muscle spasms, and pneumonia, as well as adverse events leading to treatment discontinuation, were less common among zanubrutinib recipients. Incidence of neutropenia was higher with zanubrutinib, although grade ≥3 infection rates were similar in both arms (1.2 and 1.1 events per 100 person-months). These results demonstrate that zanubrutinib and ibrutinib are highly effective in the treatment of WM, but zanubrutinib treatment was associated with a trend toward better response quality and less toxicity, particularly cardiovascular toxicity.

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Metadata

Authors
Tam, C. S., Opat, S., D'Sa, S., Jurczak, W., Lee, H.-P., Cull, G., Owen, R. G., Marlton, P., Wahlin, B. E., Sanz, R. G., McCarthy, H., Mulligan, S., Tedeschi, A., Castillo, J. J., Czyz, J., Fernández de Larrea, C., Belada, D., Libby, E., Matous, J. V., Motta, M., Siddiqi, T., Tani, M., Trneny, M., Minnema, M. C., Buske, C., Leblond, V., Trotman, J., Chan, W. Y., Schneider, J., Ro, S., Cohen, A., Huang, J., & Dimopoulos, M.
Venue
Blood
Publisher
American Society of Hematology
Published
2020-10-29
Volume
136
Issue
18
Pages
2038-2050
ISSN
  • 0006-4971 (ISSN-L)
  • 1528-0020
DOI
10.1182/blood.2020006844
OpenAlex
W3046825703
Cited by
466
References
31
FWCI
30.82
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. https://app.cochat.ai/papers/10.1182/blood.2020006844
The paper
Tam, C. S., Opat, S., D'Sa, S., Jurczak, W., Lee, H.-P., Cull, G., Owen, R. G., Marlton, P., Wahlin, B. E., Sanz, R. G., McCarthy, H., Mulligan, S., Tedeschi, A., Castillo, J. J., Czyz, J., Fernández de Larrea, C., Belada, D., Libby, E., Matous, J. V., . . . Dimopoulos, M. (2020). A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Blood. https://doi.org/10.1182/blood.2020006844

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.