Cited by 1,128Chronic Lymphocytic Leukemia ResearchLymphoma Diagnosis and TreatmentCutaneous lymphoproliferative disorders research

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Bruton Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765) Has Significant Activity in Patients With Relapsed/Refractory B-Cell Malignancies

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Advani, Ranjana H., Buggy, Joseph J., Sharman, Jeff P., Smith, Sonali M., Boyd, Thomas E., Grant, Barbara, Kolibaba, Kathryn S., Furman, Richard R., Rodriguez, Sara, Chang, Betty Y., Sukbuntherng, Juthamas, Izumi, Raquel, Hamdy, Ahmed, Hedrick, Eric, Fowler, Nathan H.·2013·Journal of Clinical Oncology

DOI 10.1200/jco.2012.42.7906PMC PMC5505166

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Abstract

Purpose: Survival and progression of mature B-cell malignancies depend on signals from the B-cell antigen receptor, and Bruton tyrosine kinase (BTK) is a critical signaling kinase in this pathway. We evaluated ibrutinib (PCI-32765), a small-molecule irreversible inhibitor of BTK, in patients with B-cell malignancies. Patients and Methods: Patients with relapsed or refractory B-cell lymphoma and chronic lymphocytic leukemia received escalating oral doses of ibrutinib. Two schedules were evaluated: one, 28 days on, 7 days off; and two, once-daily continuous dosing. Occupancy of BTK by ibrutinib in peripheral blood was monitored using a fluorescent affinity probe. Dose escalation proceeded until either the maximum-tolerated dose (MTD) was achieved or, in the absence of MTD, until three dose levels above full BTK occupancy by ibrutinib. Response was evaluated every two cycles. Results: Fifty-six patients with a variety of B-cell malignancies were treated over seven cohorts. Most adverse events were grade 1 and 2 in severity and self-limited. Dose-limiting events were not observed, even with prolonged dosing. Full occupancy of the BTK active site occurred at 2.5 mg/kg per day, and dose escalation continued to 12.5 mg/kg per day without reaching MTD. Pharmacokinetic data indicated rapid absorption and elimination, yet BTK occupancy was maintained for at least 24 hours, consistent with the irreversible mechanism. Objective response rate in 50 evaluable patients was 60%, including complete response of 16%. Median progression-free survival in all patients was 13.6 months. Conclusion: Ibrutinib, a novel BTK-targeting inhibitor, is well tolerated, with substantial activity across B-cell histologies.

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Khan, W. N., Lacoume, G. M., & Greidinger, E. L. (2025) · Autoimmunity · doi:10.1080/08916934.2025.2531766 · Cited by 4
A decade of ibrutinib for CLL with and without TP53 aberration: final report on an investigator-sponsored phase 2 study
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A Case of Hypophosphatemiawith Increased Urinary Excretion of Phosphorus Associated with Ibrutinib
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A phase I study of nedaplatin, pemetrexed and thoracic intensity-modulated radiotherapy for inoperable stage III lung adenocarcinoma
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Walking a tightrope: clinical use of ibrutinib in mantle cell lymphoma in the elderly
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“Across the studies in r/r MCL, single-agent ibrutinib led to an ORR of 67% to 72% and complete responses of 19% to 33%.(14,17,18) In a subgroup analysis of the trial comparing ibrutinib with temsirolimus, the PFS advantage of ibrutinib was maintained in the elderly population.”
Background
Ibrutinib in the Treatment of Refractory Chronic Lymphocytic Leukemia
Nikitin, E. A., Dmitrieva, E. A., Panteleev, M. A., Emelina, E. L., Ivanova, V. L., Kochkareva, Y. B., Arshanskaya, E. G., Lazarev, I. E., Markova, E. E., Mukha, L. A., et al. (2017) · Clinical oncohematology · doi:10.21320/2500-2139-2017-10-3-271-281 · Cited by 3
Venetoclax for the treatment of mantle cell lymphoma
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“Ibrutinib is an oral covalent inhibitor of Bruton’s tyrosine kinase (BTK), an essential component of the B cell receptor (BCR) signalling pathway, which has shown high clinical efficacy across a range of B cell cancers including CLL and MCL (62,63).”
Background
An evaluation of Ibrutinib for the treatment of Waldenstrom macroglobulinaemia
Lim, K. J. C., & Tam, C. S. L. (2020) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2020.1770727 · Cited by 3
“No accumulation of Ibrutinib was found with a daily dosing schedule [28].”
Background
Evaluating ibrutinib for the treatment of relapsed/refractory marginal zone lymphoma
Cavalloni, C., Varettoni, M., Rattotti, S., & Arcaini, L. (2021) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2021.1941864 · Cited by 3
“a biphasic manner, with an initial mean half-life of 2–3 hours and a terminal elimination half-life of 4–8 hours [13,15].”
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Chronic Lymphocytic Leukemia (CLL): Biology and Therapy
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Lymphomes spléniques : diagnostic et prise en charge
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How We Manage Patients with Indolent B-Cell Malignancies on Bruton’s Tyrosine Kinase Inhibitors: Practical Considerations for Nurses and Pharmacists
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Fatal Cryptococcal Meningitis in a Patient With Chronic Lymphocytic Leukemia Treated With Ibrutinib
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“These side effects are generally transient and often do not require therapeutic intervention or interruption of treatment [9-12].”
Background
Quantitative Systems Pharmacology Model to Predict Target Occupancy by Bruton Tyrosine Kinase Inhibitors in Patients With B‐Cell Malignancies
Demin, O. O., Ou, Y. C., Kolesova, G., Shchelokov, D., Stepanov, A. A., Musatova, V., Sahasranaman, S., Zhao, Y., Liu, X., Tang, Z., et al. (2025) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.13307 · Cited by 3
“BTK occupancy to assess target engagement following treat-ment with BTK inhibitors is one of the key biomarkers thought to correlate with clinical activity [4].”
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“Ibrutinib semble efficace dans d’autres hémopathies B telles que la maladie de Waldenström où son administration a été approuvée aux États-Unis en janvier 2015.”
Influential
Functional imaging in combination with mutation status aids prediction of response to inhibiting B-cell receptor signaling in lymphoma
Jacobs, L., Habringer, S., Slawska, J., Huber, K., Hauf, E., Li, Z., Refaeli, Y., Schwaiger, M., Rudelius, M., Walch, A. K., et al. (2017) · Oncotarget · doi:10.18632/oncotarget.20551 · Cited by 3
“The BTK inhibitor ibrutinib has been approved for lymphomas such as CLL [28], mantle cell lymphoma [29] and Waldenström’s disease [30, 31] that critically depend on constitutively activated BCR signaling.”
BackgroundInfluential
Analiza skuteczności ibrutynibu w podgrupie chorych na przewlekłą białaczkę limfocytową z delecją 17p: badanie obserwacyjne Polskiej Grupy ds. Leczenia Białaczek u Dorosłych (PALG)
Puła, B., Iskierka‐Jazdzewska, E., Hus, M., Szymczyk, A., Gołoś, A., Piotrowska, M., Zawirska, D., Zaucha, J. M., Steckiewicz, P., Pasiarski, M., et al. (2017) · Acta Haematologica Polonica · doi:10.1016/j.achaem.2017.10.004 · Cited by 3
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Background
Management of ibrutinib treatment in patients with B-cell malignancies: clinical practice in Portugal and multidisciplinary recommendations
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Zanubrutinib for the treatment of adults with Waldenstrom macroglobulinemia
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“The safety of the first BTK inhibitor, ibrutinib, was initially evaluated in a phase I clinical trial of relapsed and refractory non-Hodgkin lymphoma, including four patients with WM [14].”
Background
New oral small molecules in the treatment of chronic lymphocytic leukemia
Lamanna, N. (2015) · Cancer · doi:10.1002/cncr.29130 · Cited by 3
“In an early phase 1 trial with ibrutinib, there was no maximum tolerated dose (MTD) reached with mild to moderate toxicity and clinical activity was noted in 56 patients with recurrent/refractory B-cell malignancies.(11) The me-”
Background
Role of Tyrosine Kinase Inhibitors in Indolent and Other Mature B-Cell Neoplasms
Kutsch, N., Marks, R., Ratei, R., Held, T. K., & Schmidt‐Hieber, M. (2015) · Biomarker Insights · doi:10.4137/bmi.s22434 · Cited by 3
Emerging protein kinase inhibitors for the treatment of non-Hodgkin’s lymphoma
Jahangiri, S., Friedberg, J. W., & Barr, P. M. (2014) · Expert Opinion on Emerging Drugs · doi:10.1517/14728214.2014.929663 · Cited by 3
Section II: Hematolymphoid malignancies
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Small-Molecule Inhibitors of Bruton’s Tyrosine Kinase
Zuo, Y., & Pan, Z. (2017) · Topics in medicinal chemistry · doi:10.1007/7355_2017_6 · Cited by 3
A phase II trial of bendamustine in combination with ofatumumab in patients with relapsed or refractory marginal zone B‐cell lymphomas
Vannata, B., Vanazzi, A., Negri, M., Liptrott, S. J., Bartosek, A. A., Miani, M., Sanzo, A. D., Cavalli, F., Zucca, E., & Stathis, A. (2020) · Hematological Oncology · doi:10.1002/hon.2822 · Cited by 3
“In the United States, the Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, has been approved by the Food and Drug Administration (FDA) for relapsed/refractory MZL based on the results of a small phase II trial.(3,4) The relative rarity and heterogeneity of MZLs result in lack of dedicated clinical trials, and soli…”
Background
Successful treatment of second-time CAR-T 19 therapy after failure of first-time CAR-T 19 and ibrutinib therapy in relapsed mantle cell lymphoma
Mu, J., Liu, M., Wang, J., Meng, J., Zhang, R., Jiang, Y., & Deng, Q. (2022) · Advances in Clinical and Experimental Medicine · doi:10.17219/acem/145948 · Cited by 3
Ibrutinib dose and clinical outcome in chronic lymphocytic leukemia - learning from the ‘real world’
Bose, P., Chen, L. S., & Gandhi, V. V. (2019) · Leukemia & lymphoma/Leukemia and lymphoma · doi:10.1080/10428194.2019.1571207 · Cited by 3
“175mg/day for an average 70-kg patient [11].”
Designing Dose-Finding Phase I Clinical Trials: Top Questions That Should Be Discussed With Your Clinical Pharmacologist
Ratain, M. J. (2021) · JCO Precision Oncology · doi:10.1200/po.21.00065 · Cited by 3
Ibrutinib for the treatment of chronic lymphocytic leukemia
Farooqui, M. Z. H., & Wiestner, A. U. (2013) · Expert Opinion on Orphan Drugs · doi:10.1517/21678707.2013.850413 · Cited by 2
“This so-called redistribution lymphocytosis [37] is a direct effect of ibrutinib as illustrated in studies using intermittent dosing, which resulted in a saw tooth pattern of rising ALC on drug, and falling ALC off drug [48].”
BackgroundResultInfluential
Emerging Immunotherapy and Strategies Directly Targeting B Cells for the Treatment of Diffuse Large B-cell Lymphoma
Witkowska, M., & Smolewski, P. (2015) · Immunotherapy · doi:10.2217/imt.14.93 · Cited by 2
Rationnel et modalités de prescription de l’ibrutinib dans les hémopathies lymphoïdes B
Dougé, A., Ravinet, A., Bay, J., Tournilhac, O., Guièze, R., & Lemal, R. (2016) · Bulletin du Cancer · doi:10.1016/j.bulcan.2015.12.003 · Cited by 2
Personalized Cancer Therapy
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Targeting Bruton Tyrosine Kinase: A novel strategy in the treatment of B-cell lymphomas
Sklavenitis‐Pistofidis, R., Κoletsa, T., Lazaridou, A., & Goulas, A. (2017) · Forum of Clinical Oncology · doi:10.1515/fco-2015-0026 · Cited by 2
“6 months.[43] Subsequently, a phase 1b-2 study of ibrutinib in relapsed CLL patients registered an overall response rate of 71% with 83% overall survival (OS); the responses were sustained and only varied according to IGHV mutation status (77% response in U-CLL and 33% in M-CLL).”
Background
Rapid but reversible progression and transformation of chronic lymphocytic leukemia after temporary ibrutinib discontinuation due to off-target toxicity: two interesting cases
Coppola, P. E., Broccoli, A., Argnani, L., Casadei, B., Stefoni, V., Bertuzzi, C., Sabattini, E., & Zinzani, P. L. (2021) · Leukemia & lymphoma/Leukemia and lymphoma · doi:10.1080/10428194.2021.1961241 · Cited by 2
“The Bruton’s tyrosine kinase (BTK) is a key component of proximal BCR signaling: its expression is upregulated in CLL cells relative to nonmalignant B-cells, and the use of BTK-inhibitors leads to direct cytotoxicity, inhibition of proliferation, disruption in cytokine and chemokine signaling and inhibition of cell mi…”
Background
Non-Hodgkin Lymphoma
Hochberg, J. C., El‐Mallawany, N. K., Brugières, L., McMillan, A., & Cairo, M. S. (2016) · Pediatric oncology · doi:10.1007/978-3-319-33679-4_4 · Cited by 2
Ibrutinib Associated with Rituximab-Platinum Salt-Based Immunochemotherapy in B-Cell Lymphomas: Results of a Phase 1b-II Study of the LYSA Group
Bonnet, C. M., Dupuis, J., Tilly, H., Lamy, T., Fruchart, C., Gouill, S. L., Thiéblemont, C., Morschhauser, F., Casasnovas, O., Bouabdallah, K. K., et al. (2022) · Cancers · doi:10.3390/cancers14071761 · Cited by 2
“Patients with second-line treatment or relapse after ASCT now have access to CAR-T cell therapy [4,5].”
BackgroundInfluential
The Use of Bruton Tyrosine Kinase Inhibitors in Waldenström’s Macroglobulinemia
Khan, A. (2022) · Journal of Personalized Medicine · doi:10.3390/jpm12050676 · Cited by 2
“In a phase I trial of ibrutinib in patients with relapsed/refractory (R/R) NHL, three out of four WM patients demonstrated a partial response (PR) and the fourth had stable disease (SD) [18].”
Background
Cardiac toxicity in a pilot study of duvelisib and ibrutinib combination therapy for chronic lymphocytic leukaemia
Paul, S. R., Rosing, D. R., Haigney, M. C., Peer, C. J., Figg, W. D., Wiestner, A. U., & Sun, C. (2022) · British Journal of Haematology · doi:10.1111/bjh.18558 · Cited by 2
Racial disparities in the incidence and survival outcomes in diffuse large B‐cell lymphoma in adolescents and young adults
Wasifuddin, M., Ilerhunmwuwa, N. P., Becerra, H., Hakobyan, N., Shrestha, N., Uche, I. N., Lin, H., Abowali, H. A., Zheng, J., Yadav, R., et al. (2024) · European Journal Of Haematology · doi:10.1111/ejh.14255 · Cited by 2
Discovery of Covalent Bruton's Tyrosine Kinase Inhibitors with Decreased CYP2C8 Inhibitory Activity
Qiu, H., Ali, Z., Bowlan, J., Caldwell, R. D., Gardberg, A. S., Glaser, N., Goutopoulos, A., Head, J. C., Johnson, T. L., Maurer, C. K., et al. (2021) · ChemMedChem · doi:10.1002/cmdc.202100453 · Cited by 2
Personalized Therapy of Cancer
Jain, K. K. (2015) · Springer eBooks · doi:10.1007/978-1-4939-2553-7_10 · Cited by 2
The emerging role of ibrutinib in the treatment of chronic lymphocytic leukemia
Molica, S. (2013) · Expert Review of Hematology · doi:10.1586/17474086.2013.831324 · Cited by 2
Chronic Lymphocytic Leukemia-Era of Targeted Therapy
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“최근 재발/불응성 B세 포 종양을 가진 56명의 환자를 대상으로 시행되었던 임상시 험의 결과가 보고되었는데, 이중에 포함되었던 16명의 만성 림프구성백혈병 환자 모두에서 25% 이상의 종양부담의 감 소를 보여준 바 있다[51].”

Authors: Advani, R. H., Buggy, J. J., Sharman, J. P., Smith, S. M., Boyd, T. E., Grant, B., Kolibaba, K. S., Furman, R. R., Rodriguez, S., Chang, B. Y., Sukbuntherng, J., Izumi, R., Hamdy, A., Hedrick, E., & Fowler, N. H.
Affiliations: University of Vermont (US)
Corresponding author: Advani, Ranjana H.
ORCID: Advani, Ranjana H.
Sharman, Jeff P.
Smith, Sonali M.
Kolibaba, Kathryn S.
Furman, Richard R.
Chang, Betty Y.
Izumi, Raquel
Hamdy, Ahmed
Fowler, Nathan H.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2013-01-01
Volume: 31
Issue: 1
Pages: 88-94
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2012.42.7906
PMC: PMC5505166
OpenAlex: W2171771895
Cited by: 1,128
References: 32
Citations by year: 2026: 17 · 2025: 38 · 2024: 47 · 2023: 44 · 2022: 46 · 2021: 90 · 2020: 79 · 2019: 92 · 2018: 73 · 2017: 117 · 2016: 94 · 2015: 135 · 2014: 134 · 2013: 110
FWCI: 58.95
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Journal of Clinical Oncology (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: Abbott Laboratories
GlaxoSmithKline
Gilead Sciences
Celgene
Genentech
Takeda Oncology
Pharmacyclics
National Cancer Institute (P30CA016672)
Topics: Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
Health Sciences › Medicine › Dermatology › Cutaneous lymphoproliferative disorders research
Keywords: ibrutinib, BTK inhibitors, relapsed/refractory B-cell malignancies, B-cell lymphoma, chronic lymphocytic leukemia, B cell receptor signaling, irreversible kinase inhibitors, BTK occupancy, dose-limiting toxicity, pharmacokinetics, progression-free survival
MeSH terms: Agammaglobulinaemia Tyrosine Kinase, Adenine, Administration, Oral, Adult, Aged, Aged, 80 and over, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Piperidines, Prognosis, Protein-Tyrosine Kinases, Pyrazoles, Pyrimidines, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Salvage Therapy, Drug Resistance, Neoplasm, Maximum Tolerated Dose, Protein Kinase Inhibitors

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Bruton Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765) Has Significant Activity in Patients With Relapsed/Refractory B-Cell Malignancies

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