Advanced search
Publication Cover
Leukemia & Lymphoma Volume 62, 2021 - Issue 10
Submit an article Journal homepage
445
Views
1
CrossRef citations to date
0
Altmetric
Original Articles

Phase I, first-in-human trial of Bruton’s tyrosine kinase inhibitor M7583 in patients with B-cell malignancies

Wojciech Jurczaka Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Kraków, PolandView further author information
,
Simon Ruleb Department of Haematology, Plymouth University Medical School, Plymouth, UKORCID Iconhttps://orcid.org/0000-0001-8937-6351View further author information
ORCID Icon,
William Townsendc Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK;d NIHR/UCLH Clinical Research Facility, University College London Hospitals NHS Foundation Trust, London, UKView further author information
,
David Tuckere Department of Haematology, Royal Cornwall Hospitals NHS Trust, Truro, UKView further author information
,
Barbara Sarholzf R&D Global Biostatistics & Epidemiology, Merck KGaA, Darmstadt, GermanyView further author information
,
Jürgen Scheeleg EMD Serono Research & Development Institute, Inc., Billerica, MA, USA(an affiliate of Merck KGaA, Darmstadt, Germany)Correspondence[email protected]
View further author information
,
Martin Dyroffg EMD Serono Research & Development Institute, Inc., Billerica, MA, USA(an affiliate of Merck KGaA, Darmstadt, Germany)View further author information
,
John G. Gribbenh Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UKView further author information
,
Monika Długosz-Daneckaa Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Kraków, PolandView further author information
&
Pier Luigi Zinzanii Institute of Haematology "Seràgnoli" University of Bologna, Bologna, ItalyView further author information
 show all
Pages 2392-2399 | Received 24 Jun 2020, Accepted 24 Mar 2021, Published online: 24 Apr 2021

References

  • Tan SL, Liao C, Lucas MC, et al. Targeting the SYK-BTK axis for the treatment of immunological and hematological disorders: recent progress and therapeutic perspectives. Pharmacol Ther. 2013;138(2):294–309.
  • Honigberg LA, Smith AM, Sirisawad M, et al. The Bruton tyrosine kinase inhibitor PCI-32765 blocks B-cell activation and is efficacious in models of autoimmune disease and B-cell malignancy. Proc Natl Acad Sci USA. 2010;107(29):13075–13080.
  • Food and Drug Administration. Highlights of prescribing information: Imbruvica; 2018; [cited 2020 Aug 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563-orig2lbl.pdf
  • Byrd JC, Brown JR, O'Brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371(3):213–223.
  • Wang ML, Rule S, Martin P, et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013;369(6):507–516.
  • Treon SP, Tripsas CK, Meid K, et al. Ibrutinib in previously treated Waldenstrom's macroglobulinemia. N Engl J Med. 2015;372(15):1430–1440.
  • Jerkeman M, Hallek M, Dreyling M, et al. Targeting of B-cell receptor signalling in B-cell malignancies. J Intern Med. 2017;282(5):415–428.
  • Goodstal SM, Ma J, Lin J, et al. M7583 is a highly selective and potent second generation BTK inhibitor for treatment of B-cell malignancies. Blood. 2017;130:3845.
  • Bender AT, Pereira A, Fu K, et al. Btk inhibition treats TLR7/IFN driven murine lupus. Clin Immunol. 2016;164:65–77.
  • Jurczak W, Rule S, Townsend W, et al. First in human, phase I/II trial of the Bruton's tyrosine kinase inhibitor (BTKi) M7583 in patients with B cell malignancies: study design and initial outcomes. Blood. 2017;130:2778.
  • Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25(5):579–586.
  • Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008;111(12):5446–5456.
  • Owen RG, Kyle RA, Stone MJ, et al. Response assessment in Waldenström macroglobulinaemia: update from the VIth International Workshop. Br J Haematol. 2013;160(2):171–176.
  • Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018;391(10121):659–667.
  • Byrd JC, Harrington B, O'Brien S, et al. Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. N Engl J Med. 2016;374(4):323–332.
  • Brown JR, Hillmen P, O'Brien S, et al. Extended follow-up and impact of high-risk prognostic factors from the phase 3 RESONATE study in patients with previously treated CLL/SLL. Leukemia. 2018;32(1):83–91.
  • Byrd JC, Furman RR, Coutre SE, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369(1):32–42.
  • Dimopoulos MA, Trotman J, Tedeschi A, et al. Ibrutinib for patients with rituximab-refractory Waldenstrom's macroglobulinaemia (iNNOVATE): an open-label substudy of an international, multicentre, phase 3 trial. Lancet Oncol. 2017;18(2):241–250.
  • Leong DP, Caron F, Hillis C, et al. The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis. Blood. 2016;128(1):138–140.
  • Caron F, Leong DP, Hillis C, et al. Current understanding of bleeding with ibrutinib use: a systematic review and meta-analysis. Blood Adv. 2017;1(12):772–778.
  • Treon SP, Meid K, Gustine J, et al. Long-term follow-up of previously treated patients who received ibrutinib for symptomatic Waldenstrom's macroglobulinemia: update of pivotal clinical trial. Blood. 2017;130:2766.
  • Trotman J, Opat S, Marlton P, et al. Bruton’s tyrosine kinase (BTK) inhibitor BGB-3111 demonstrates high very good partial response (VGPR) rate in patients with Waldenstrom macroglobulinemia (WM). Hematol Oncol. 2017;35:70–71.
  • Wang ML, Blum KA, Martin P, et al. Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results. Blood. 2015;126(6):739–745.
  • Tam C, Grigg AP, Opat S, et al. The BTK inhibitor, BGB-3111, is safe, tolerable, and highly active in patients with relapsed/refractory B-cell malignancies: initial report of a phase 1 first-in-human trial. Blood. 2015;126(23):832.
  • Davids MS, Kim HT, Nicotra A, et al. Umbralisib in combination with ibrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia or mantle cell lymphoma: a multicentre phase 1-1b study. Lancet Haematol. 2019;6(1):e38–e47.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.