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Cited by 489

The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index.

Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia

Open access
Brown, Jennifer R., Eichhorst, Barbara, Hillmen, Peter, Jurczak, Wojciech, Kaźmierczak, Maciej, Lamanna, Nicole, O’Brien, Susan M., Tam, Constantine S., Qiu, Lugui, Zhou, Keshu, Simkovic, Martin, Mayer, Jiri, Gillespie-Twardy, Amanda, Ferrajoli, Alessandra, Ganly, Peter S., Weinkove, Robert, Grosicki, Sebastian, Mital, Andrzej, Robak, Tadeusz, Osterborg, Anders, Yimer, Habte A., Salmi, Tommi, Wang, Megan-Der-Yu, Fu, Lina, Li, Jessica, Wu, Kenneth, Cohen, Aileen, Shadman, Mazyar·2023·New England Journal of Medicine

Abstract

BACKGROUND: In a multinational, phase 3, head-to-head trial, ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, was compared with zanubrutinib, a BTK inhibitor with greater specificity, as treatment for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In prespecified interim analyses, zanubrutinib was superior to ibrutinib with respect to overall response (the primary end point). Data from the final analysis of progression-free survival are now available. METHODS: We randomly assigned, in a 1:1 ratio, patients with relapsed or refractory CLL or SLL who had received at least one previous course of therapy to receive zanubrutinib or ibrutinib until the occurrence of disease progression or unacceptable toxic effects. In this final analysis, progression-free survival (a key secondary end point) was assessed with the use of a hierarchical testing strategy to determine whether zanubrutinib was noninferior to ibrutinib. If noninferiority was established, the superiority of zanubrutinib was assessed and claimed if the two-sided P value was less than 0.05. RESULTS: mutation, or both, those who received zanubrutinib had longer progression-free survival than those who received ibrutinib (hazard ratio for disease progression or death, 0.53; 95% CI, 0.31 to 0.88); progression-free survival across other major subgroups consistently favored zanubrutinib. The percentage of patients with an overall response was higher in the zanubrutinib group than in the ibrutinib group. The safety profile of zanubrutinib was better than that of ibrutinib, with fewer adverse events leading to treatment discontinuation and fewer cardiac events, including fewer cardiac events leading to treatment discontinuation or death. CONCLUSIONS: In patients with relapsed or refractory CLL or SLL, progression-free survival was significantly longer among patients who received zanubrutinib than among those who received ibrutinib, and zanubrutinib was associated with fewer cardiac adverse events. (Funded by BeiGene; ALPINE ClinicalTrials.gov number, NCT03734016.).

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Metadata

Authors
Brown, J. R., Eichhorst, B., Hillmen, P., Jurczak, W., Kaźmierczak, M., Lamanna, N., O’Brien, S. M., Tam, C. S., Qiu, L., Zhou, K., Simkovic, M., Mayer, J., Gillespie-Twardy, A., Ferrajoli, A., Ganly, P. S., Weinkove, R., Grosicki, S., Mital, A., Robak, T., Osterborg, A., Yimer, H. A., Salmi, T., Wang, M.-D.-Y., Fu, L., Li, J., Wu, K., Cohen, A., & Shadman, M.
Venue
New England Journal of Medicine
Published
2023-01-26
Volume
388
Issue
4
Pages
319-332
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W4311293040
Cited by
489
References
26
FWCI
48.57
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia. https://app.cochat.ai/papers/10.1056/nejmoa2211582
The paper
Brown, J. R., Eichhorst, B., Hillmen, P., Jurczak, W., Kaźmierczak, M., Lamanna, N., O’Brien, S. M., Tam, C. S., Qiu, L., Zhou, K., Simkovic, M., Mayer, J., Gillespie-Twardy, A., Ferrajoli, A., Ganly, P. S., Weinkove, R., Grosicki, S., Mital, A., Robak, T., . . . Shadman, M. (2023). Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2211582

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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.