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Bruton Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765) Has Significant Activity in Patients With Relapsed/Refractory B-Cell Malignancies
Open accessAbstract
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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“The rapid clearance of ibrutinib (which has a half-life of 2–3 h) could also enable kinase selectivity; ibrutinib should maintain activity against BTK owing to prolonged covalent engagement, while the reversible inhibition of off-targets is minimized65.”
From Advances in covalent drug discovery (2022) · cites this paper as [65]
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Ibrutinib: a paradigm shift in management of CLL
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“demonstrate greater activity and are undergoing active investigation [26].”
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“Ibrutinib has shown to be active also in NHL [63].”
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“(9) Chronic activation of BTK-mediated signaling represents a key driver for a number types of cancers, (10-14) including AML.”
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“NCT01109069) in patients with chronic lymphocytic leukemia and B-cell lymphoma, including EBV-associated lymphoma (72), and may therefore be another candidate drug against KS that would merit evaluation in clinical trials.”
BackgroundIbrutinib in primary central nervous system diffuse large B-cell lymphoma
Low, J., & Peters, K. B. (2020) · CNS Oncology · doi:10.2217/cns-2019-0022 · Cited by 16
“A large, single-institution retrospective study found an overall invasive fungal infection incidence of 3.2% among 1191 patients admitted for chronic lymphoproliferative disorders, including CLL, Hodgkin lymphoma, non-Hodgkin lymphoma and multiple myeloma [43].”
BackgroundInfluentialIbrutinib Inhibits Angiogenesis and Tumorigenesis in a BTK-Independent Manner
Liu, J., Liu, Z., Zhang, J., Chen, X., Chen, J., Sui, L., & Yu, J. (2022) · Pharmaceutics · doi:10.3390/pharmaceutics14091876 · Cited by 16
“Ibrutinib is the first-class BTKi approved by FDA in 2013, binding to Cys-481 residue in the ATP binding domain of BTK irreversibly, and thereby impairing tumor-cell survival via inhibiting BCR signaling [4].”
BackgroundImproving the Solubility and Dissolution of Ibrutinib by Preparing Solvates
Shi, X., Song, S., Ding, Z., Fan, B., Xu, T., & Huang, W. Z. (2019) · Journal of Pharmaceutical Innovation · doi:10.1007/s12247-019-09402-7 · Cited by 16
Long-Term Efficacy and Safety of Ibrutinib in the Treatment of CLL Patients: A Real Life Experience
Broccoli, A., Argnani, L., Morigi, A., Nanni, L., Casadei, B., Pellegrini, C., Stefoni, V., & Zinzani, P. L. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10245845 · Cited by 14
“Despite the undisputed benefit on survival functions and the significant incidence of responses, the amount of complete responses (CR) remains low [3–7]: this means that a continuous administration of the drug is required to keep patients in remission, as a tonic inhibition of BTK is necessary to counteract the contin…”
Backgroundde Rooij, M. F. M., Thus, Y. J., Swier, N., Beijersbergen, R. L., Pals, S. T., & Spaargaren, M. (2022) · Nature Communications · doi:10.1038/s41467-022-29835-y · Cited by 15
Vargas-Blanco, D. A., Hepworth, O. W., Basham, K. J., Simaku, P., Crossen, A. J., Timmer, K. D., Hopke, A. R., Brown, H. E., Vandal, S. R., Jensen, K. N., et al. (2024) · JCI Insight · doi:10.1172/jci.insight.176162 · Cited by 16
Dielschneider, R. F., Xiao, W., Yoon, J.-Y., Noh, E., Banerji, V., Li, H., Marshall, A. J., Johnston, J. B., & Gibson, S. B. (2014) · Cell Death and Disease · doi:10.1038/cddis.2014.391 · Cited by 15
Mato, A. R., Jauhari, S., & Schuster, S. J. (2015) · American Journal of Hematology · doi:10.1002/ajh.24021 · Cited by 15
Batlle‐López, A., de Villambrosía, S. G., Núñez, J., Cagigal, M. L., Montes‐Moreno, S., Conde, E., & Piris, M. A. (2016) · Expert Review of Anticancer Therapy · doi:10.1586/14737140.2016.1149065 · Cited by 15
“The deregulated expression of these molecules has been clearly shown by Nicolae and coworkers in a series of young patients with EVB-positive DLBCL.[19] It is very likely that these molecules are also expressed in elderly patients, but this requires confirmation.”
BackgroundInfluentialSmith, C. I. E. (2016) · Seminars in Cancer Biology · doi:10.1016/j.semcancer.2016.11.008 · Cited by 15
Rodgers, T. D., & Reagan, P. M. (2018) · Expert Opinion on Emerging Drugs · doi:10.1080/14728214.2018.1479396 · Cited by 16
“Of the nine patients with relapsed/refractory MCL, seven had at least a partial response [68].”
BackgroundNinomoto, J. S., Mokatrin, A., Kinoshita, T., Marimpietri, C., Barrett, T. D., Chang, B. Y., Sukbuntherng, J., James, D. F., & Crowther, M. A. (2020) · Hematology · doi:10.1080/16078454.2020.1730080 · Cited by 15
Self-citationSmall, S. H., & Ma, S. (2021) · Current Hematologic Malignancy Reports · doi:10.1007/s11899-021-00637-1 · Cited by 15
Campregher, P. V., & Hamerschlak, N. (2014) · Clinical Lymphoma Myeloma & Leukemia · doi:10.1016/j.clml.2013.12.016 · Cited by 16
Ibrutinib for treatment of chronic lymphocytic leukemia
Vela, C. M., McBride, A., Jaglowski, S. M., & Andritsos, L. A. (2016) · American Journal of Health-System Pharmacy · doi:10.2146/ajhp140760 · Cited by 15
“of grade 3 allergic hypersensitivity and 1 patient who interrupted ibrutinib treatment for more than 7 days as a result of a transient grade 2 neutropenia.(24) Twenty patients died during the study periods or within 30 days of their last ibrutinib treatment.”
BackgroundInfluentialWaldron, M., Winter, A. M., & Hill, B. T. (2017) · Clinical Pharmacokinetics · doi:10.1007/s40262-017-0529-1 · Cited by 15
“In a phase I open-label study of ibrutinib in patients with relapsed or refractory non-Hodgkin lymphoma (NHL), CLL, or Waldenström macroglobulinemia, 56 patients received ibrutinib oral capsules once daily in one of seven dosing cohorts [14].”
BackgroundSawalha, Y., Bond, D. A., & Alinari, L. (2020) · OncoTargets and Therapy · doi:10.2147/ott.s238832 · Cited by 15
Edlund, H., Buil‐Bruna, N., Vishwanathan, K., Wei, H., Raman, R. K., de Kock, M., He, Z., Liu, H. L., Baek, M. S., Ware, J. A., et al. (2021) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.15087 · Cited by 14
“Similar results for BTK occupancy have been reported for ibrutinib (>95% BTK occupancy in PBMCs following QD regimens) and zanubrutinib (>95% BTK occupancy in PBMCs and lymph nodes in the majority of patients following 160-mg BID regimen).(24,25)”
ResultNon-Hodgkin Lymphoma Metabolism
Kirsch, B. J., Chang, S., Betenbaugh, M. J., & Le, A. (2021) · Advances in experimental medicine and biology · doi:10.1007/978-3-030-65768-0_7 · Cited by 17
Mantle cell lymphoma management trends and novel agents: where are we going?
Pu, J. J., Savani, M., Huang, N., & Epner, E. M. (2022) · Therapeutic Advances in Hematology · doi:10.1177/20406207221080743 · Cited by 15
Bravo-González, A., Alasfour, M., Soong, D., Noy, J., & Pongas, G. N. (2024) · Cancers · doi:10.3390/cancers16203434 · Cited by 14
“The first clinical data demonstrating the fundamental therapeutic role of BTKi in patients with relapsed/refractory B-cell lymphoma and CLL were described in a phase I trial by Advani et al., where Ibrutinib (Imbruvica) showed an objective response rate (ORR) of 60% (Table 1) [23].”
BackgroundChung, C., & Lee, R. (2014) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1002/phar.1509 · Cited by 14
Nikitin, E. A., Kislova, M. I., Morozov, D., Belyakova, V., Suvorova, A., Sveshnikova, J., Vyscub, G., Matveeva, I., Shirokova, M., Шипаева, А. Л., et al. (2023) · Leukemia · doi:10.1038/s41375-023-01891-3 · Cited by 15
Current approach to Waldenström macroglobulinemia
Kapoor, P., & Rajkumar, S. V. (2023) · Blood Reviews · doi:10.1016/j.blre.2023.101129 · Cited by 14
Lone, W., Bouska, A. C., Herek, T. A., Amador, C., Song, J. Y., Xu, A. M., Jochum, D. T., Issa, I. I., Weisenburger, D. D., Zhang, X., et al. (2024) · American Journal of Hematology · doi:10.1002/ajh.27513 · Cited by 14
“30 Currently, ibrutinib is approved for several B-cell malignancies, 39 and is active for ABC-DLBCL with MYD88 / CD79A/B mutations.”
Palomba, M., Piersanti, K., Ziegler, C. G. K., Decker, H., Cotari, J., Bantilan, K., Rijo, I., Gardner, J., Heaney, M., Bemis, D., et al. (2014) · PLoS ONE · doi:10.1371/journal.pone.0079987 · Cited by 13
Transplantation for mantle cell lymphoma: is it the right thing to do?
Williams, M. E. (2013) · Hematology · doi:10.1182/asheducation-2013.1.568 · Cited by 14
Evaluating ibrutinib in the treatment of symptomatic Waldenstrom’s macroglobulinemia
Παπανώτα, Α.-Μ., Ntanasis‐Stathopoulos, I., Kastritis, E., Dimopoulos, M. A., & Gavriatopoulou, M. (2019) · Journal of Blood Medicine · doi:10.2147/jbm.s183997 · Cited by 14
“Three of four WM patients responded to ibrutinib.(34) Efficacy of ibrutinib in symptomatic WM patients that have received at least one prior therapy was tested in a landmark Phase II study conducted by Treon et al (Table 1).”
BackgroundUminski, K., Brown, K. R., Bucher, O., Hibbert, I., Dhaliwal, D. H. S., Johnston, J. B., Geirnaert, M., Dawe, D. E., & Banerji, V. (2019) · Current Oncology · doi:10.3747/co.26.4957 · Cited by 14
Metadata
- 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
- Venue
- Journal of Clinical Oncology
- Published
- 2013-01-01
- Volume
- 31
- Issue
- 1
- Pages
- 88-94
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- 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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