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Cited by 361

The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.

Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL

Open access
Tam, Constantine S., Trotman, Judith, Opat, Stephen, Burger, Jan A., Cull, Gavin, Gottlieb, David, Harrup, Rosemary, Johnston, Patrick B., Marlton, Paula, Munoz, Javier, Seymour, John F., Simpson, David, Tedeschi, Alessandra, Elstrom, Rebecca, Yu, Yiling, Tang, Zhiyu, Han, Lynn, Huang, Jane, Novotny, William, Wang, Lai, Roberts, Andrew W.·2019·Blood
DOI 10.1182/blood.2019001160
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Abstract

Zanubrutinib is a potent and highly selective inhibitor of Bruton tyrosine kinase (BTK). In this first-in-human, open-label, multicenter, phase 1 study, patients in part 1 (3 + 3 dose escalation) had relapsed/refractory B-cell malignancies and received zanubrutinib 40, 80, 160, or 320 mg once daily or 160 mg twice daily. Part 2 (expansion) consisted of disease-specific cohorts, including treatment-naive or relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The primary end points were safety and tolerability, and definition of the maximum tolerated dose (part 1). Additional end points included pharmacokinetics/pharmacodynamics and preliminary efficacy. Reported herein are results from 144 patients enrolled in the dose-finding and CLL/SLL cohorts. No dose-limiting toxicities occurred in dose escalation. Median BTK occupancy in peripheral blood mononuclear cells was >95% at all doses. Sustained complete (>95%) BTK occupancy in lymph node biopsy specimens was more frequent with 160 mg twice daily than 320 mg once daily (89% vs 50%; P = .0342). Consequently, 160 mg twice daily was selected for further investigation. With median follow-up of 13.7 months (range, 0.4-30.5 months), 89 CLL/SLL patients (94.7%) remain on study. Most toxicities were grade 1/2; neutropenia was the only grade 3/4 toxicity observed in >2 patients. One patient experienced a grade 3 subcutaneous hemorrhage. Among 78 efficacy-evaluable CLL/SLL patients, the overall response rate was 96.2% (95% confidence interval, 89.2-99.2). Estimated progression-free survival at 12 months was 100%. Zanubrutinib demonstrated encouraging activity in CLL/SLL patients, with a low incidence of major toxicities. This trial was registered at www.clinicaltrials.gov as #NCT02343120.

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Metadata

Authors
Tam, C. S., Trotman, J., Opat, S., Burger, J. A., Cull, G., Gottlieb, D., Harrup, R., Johnston, P. B., Marlton, P., Munoz, J., Seymour, J. F., Simpson, D., Tedeschi, A., Elstrom, R., Yu, Y., Tang, Z., Han, L., Huang, J., Novotny, W., Wang, L., & Roberts, A. W.
Venue
Blood
Publisher
American Society of Hematology
Published
2019-09-12
Volume
134
Issue
11
Pages
851-859
ISSN
  • 0006-4971 (ISSN-L)
  • 1528-0020
DOI
10.1182/blood.2019001160
OpenAlex
W2964310707
Cited by
361
References
27
FWCI
23.73
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. https://app.cochat.ai/papers/10.1182/blood.2019001160
The paper
Tam, C. S., Trotman, J., Opat, S., Burger, J. A., Cull, G., Gottlieb, D., Harrup, R., Johnston, P. B., Marlton, P., Munoz, J., Seymour, J. F., Simpson, D., Tedeschi, A., Elstrom, R., Yu, Y., Tang, Z., Han, L., Huang, J., Novotny, W., . . . Roberts, A. W. (2019). Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. https://doi.org/10.1182/blood.2019001160

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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.