Targeting BTK with Ibrutinib in Relapsed Chronic Lymphocytic Leukemia
Open accessAbstract
BACKGROUND: The treatment of relapsed chronic lymphocytic leukemia (CLL) has resulted in few durable remissions. Bruton's tyrosine kinase (BTK), an essential component of B-cell-receptor signaling, mediates interactions with the tumor microenvironment and promotes the survival and proliferation of CLL cells. METHODS: We conducted a phase 1b-2 multicenter study to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ibrutinib (PCI-32765), a first-in-class, oral covalent inhibitor of BTK designed for treatment of B-cell cancers, in patients with relapsed or refractory CLL or small lymphocytic lymphoma. A total of 85 patients, the majority of whom were considered to have high-risk disease, received ibrutinib orally once daily; 51 received 420 mg, and 34 received 840 mg. RESULTS: Toxic effects were predominantly grade 1 or 2 and included transient diarrhea, fatigue, and upper respiratory tract infection; thus, patients could receive extended treatment with minimal hematologic toxic effects. The overall response rate was the same in the group that received 420 mg and the group that received 840 mg (71%), and an additional 20% and 15% of patients in the respective groups had a partial response with lymphocytosis. The response was independent of clinical and genomic risk factors present before treatment, including advanced-stage disease, the number of previous therapies, and the 17p13.1 deletion. At 26 months, the estimated progression-free survival rate was 75% and the rate of overall survival was 83%. CONCLUSIONS: Ibrutinib was associated with a high frequency of durable remissions in patients with relapsed or refractory CLL and small lymphocytic lymphoma, including patients with high-risk genetic lesions. (Funded by Pharmacyclics and others; ClinicalTrials.gov number, NCT01105247.).
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At 26 months, the estimated progression-free survival rate among patients treated with ibrutinib is 75%.
“At 26 months, the estimated progression-free survival rate among patients treated with ibrutinib is 75%.9”
From Resistance Mechanisms for the Bruton's Tyrosine Kinase Inhibitor Ibrutinib (2014) · cites this paper as [9]
Ibrutinib has clinically significant activity in patients with relapsed CLL, with 71% objective complete or partial response and an additional 15 to 20% partial response with persistent lymphocytosis.
“Ibrutinib has been shown to have clinically significant activity in patients with relapsed CLL, with 71% of patients having an objective complete or partial response and an additional 15 to 20% of patients having a partial response with persistent lymphocytosis.”
From Resistance Mechanisms for the Bruton's Tyrosine Kinase Inhibitor Ibrutinib (2014) · cites this paper as [9]
Resistance to ibrutinib emerges due to a cysteine to serine mutation (C418S) at the ibrutinib binding site in BTK.
“the resistance to ibrutinib emerges due to a cysteine to serine mutation (C418S) at the ibrutinib binding site in BTK [113, 114].”
From Proteolysis targeting chimeras (PROTACs) are emerging therapeutics for hematologic malignancies (2020) · cites this paper as [113]
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Revised response criteria for malignant lymphoma.
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- Authors
- Byrd, J. C., Furman, R. R., Coutre, S. E., Flinn, I. W., Burger, J. A., Blum, K. A., Grant, B., Sharman, J. P., Coleman, M., Wierda, W. G., Jones, J. A., Zhao, W., Heerema, N. A., Johnson, A. J., Sukbuntherng, J., Chang, B. Y., Clow, F., Hedrick, E., Buggy, J. J., James, D. F., & O'Brien, S.
- Affiliations
- The Ohio State University (US)
- Weill Cornell Medicine (US)
- Stanford Medicine (US)
- The University of Texas MD Anderson Cancer Center (US)
- University of Vermont (US)
- Willamette Valley Cancer Institute and Research Center (US)
- Pharmacyclics (United States) (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2013-07-04
- Volume
- 369
- Issue
- 1
- Pages
- 32-42
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3772525
- OpenAlex
- W2071549499
- Cited by
- 2,270
- References
- 38
- Citations by year
- 2026: 56 · 2025: 70 · 2024: 95 · 2023: 105 · 2022: 134 · 2021: 190 · 2020: 172 · 2019: 191 · 2018: 205 · 2017: 242 · 2016: 231 · 2015: 273 · 2014: 231 · 2013: 67 · 2012: 3
- FWCI
- 131.59
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- American Society of Hematology
- Leukemia and Lymphoma Society (P01 CA095426)
- D. Warren Brown Family Foundation
- National Institutes of Health (4p01ca081534-16, CA095426, CA140158)
- Pharmacyclics
- National Cancer Institute (P01CA095426, P50CA140158, P30CA016672, P30CA016058, K12CA133250, R01CA177292, P01-CA-081534)
- Janssen Research and Development
- Topics
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Acute Lymphoblastic Leukemia research
- Keywords
- ibrutinib, BTK inhibitors, relapsed chronic lymphocytic leukemia, small lymphocytic lymphoma, B cell receptor signaling, 17p13.1 deletion, progression-free survival, overall survival, drug safety and tolerability, pharmacokinetics, pharmacodynamics, high-risk disease
- MeSH terms
- Agammaglobulinaemia Tyrosine Kinase, Adenine, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Female, Humans, Male, Middle Aged, Piperidines, Protein-Tyrosine Kinases, Pyrazoles, Pyrimidines, Recurrence, Remission Induction, Leukemia, Lymphocytic, Chronic, B-Cell, Treatment Outcome, Disease-Free Survival
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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