Resumen
La tirosina kinasa de Bruton es una tirosina kinasa expresada en todo el linaje hematopoyético, excepto en los progenitores de células T, y cumple un papel esencial en la vía del BCR. La inhibición de la BTK ha probado ser una estrategia efectiva en algunos linfomas y en leucemia linfática crónica. Ibrutinib y acalabrutinib son inhibidores de BTK aprobados en Argentina. Zanubrutinib es un iBTK más específico, lo que explicaría algunas diferencias con los previamente desarrollados. Muchos estudios con zanubrutinib en diferentes síndromes linfoproliferativos B se encuentran en desarrollo o con diferente tiempo de seguimiento y demuestran una inhibición más selectiva por parte de zanubrutinib con ocupación más completa y sostenida de la BTK, lo que resultaría en mayores beneficios en eficacia y seguridad. ia y seguridad.
Citas
2- Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) Disposición No 9440 (11/11/2015) y No 12655 (13/12/2017).
3- Mato AR, Nabhan C, Thompson MC, y col. Toxicities and outcomes of 616 ibrutinib-treated patients in the US: a real-world analysis. Haematologica. 2018;103(5):874–879.
4- Stephens DM, Byrd JC. How I manage ibrutinib intolerance and complications in patients with CLL. Blood. 2019;133(12):1298–1307.
5- Sharman JP, Egyed M, Jurczak W y col. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzumab for treatment-naive CLL (ELEVATE TN): a randomized, controlled, phase 3 trial. Lancet. 2020 Apr 18;395(10232):1278-1291.
6- Ghia P, Pluta A, Wach M y col. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL. J Clin Oncol 2020; 38:25, 2849-2861
7- Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in R/R mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018;391(10121):659-667.
8- ANMAT Disposición No 3549 (22/05/2020) y 5732 (17/07/2019).
9- Dobie G, Kurini F, Omar M y col., Ibrutinib, but not zanubrutinib, induces platelet receptor shedding of GPIb-IX-V complex and integrin αIIbβ3 in mice and humans. Blood Adv 2019; 3 (24): 4298–4311.
10- Flinsenberg TWH, Tromedjo CC, Hu N. y col., Differential effects of BTK inhibitors ibrutinib and zanubrutinib on NK-cell effector function in patients with mantle cell lymphoma. Haematologica 2020;105(2):e76-e79.
11- Tam CS, Trotman J, Opat S. y col. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;134(11):851–859.
12- Song Y., Zhou K., Zou D. y col., Treatment of Patients with R/R Mantle–Cell Lymphoma with Zanubrutinib, a Selective Inhibitor of Bruton's Tyrosine Kinase. Clin Cancer Res 2020;26:4216–24.
13- Sawalha Y. , Bond D., Alinari L. Evaluating the Therapeutic Potential of Zanubrutinib in the Treatment of R/R Mantle Cell Lymphoma: Evidence to Date. OncoTargets Ther 2020; 13: 6573-6581.
14- Tam CS, Opat S, Zhu J. y col. PS1159 pooled analysis of safety data from monotherapy studies of the BTK inhibitor, zanubrutinib (BGB-3111), in B-cell malignancies. HemaSphere. 2019;3(S1):526.
15- Weaver, A.N. and Jimeno, A. Zanubrutinib: a new BTK inhibitor for treatment of R/R mantle cell lymphoma. Drugs Today 2020, 56(8): 531.
16- Tam C, Opat S, Simpson D y col. Zanubrutinib for the treatment of R/R mantle cell lymphoma. Blood Adv 2021; 5 (12): 2577–2585.
17- Song Y. y col, (EP789) Zanubrutinib in patients with R/R MCL: long term efficacy and safety results from a phase 2 study. 2021 European Hematology Association (EHA2021) Congress in June 2021. Available at EHA Open Access Library.
18- Dreyling M, Tam C, Wang M y col., A Phase III study of zanubrutinib plus rituximab versus bendamustine plus rituximab in transplant-ineligible, untreated mantle cell lymphoma. FutureOncol (2021)17(3),255–262.
19- Soumerai J y col. (S214) TOLERABILITY AND EFFICACY OF THE COMBINATION OF PI3KΔ INHIBITOR ZANDELISIB (ME-401) AND BTK INHIBITOR ZANUBRUTINIB IN PATIENTS WITH R/R B-CELL MALIGNANCIES: INITIAL RESULTS. 2021 European Hematology Association (EHA2021) Congress in June 2021. Available at EHA Open Access Library.
20- Opat S, y col (EP783) PHASE 2 STUDY OF ZANUBRUTINIB IN PATIENTS WITH R/R MARGINAL ZONE LYMPHOMA (MAGNOLIA STUDY). 2021 European Hematology Association (EHA 2021) Congress in June 2021. Available at EHA Open Access Library.
21- Xu W, Yang S, Zhou K, y col. Treatment of R/R SLL/CLL with the BTK inhibitor zanubrutinib: phase 2, single-arm, multicenter study. J Hematol Oncol. 2020;13(1):48.
22- Tam CS, Robak T, Ghia P, et al. Efficacy and safety of zanubrutinib in patients with treatment-naive CLL or SLL with del(17p): initial results from arm C of the Sequoia (BGB-3111-304) trial.
23- https://clinicaltrials.gov/ct2/show/NCT03824483
24- https://clinicaltrials.gov/ct2/show/NCT04515238
25- https://clinicaltrials.gov/ct2/show/NCT04458610
26- Shadman M, y col (EP642) PRELIMINARY RESULTS OF THE PHASE 2 STUDY OF ZANUBRUTINIB IN PATIENTS WITH PREVIOUSLY TREATED B-CELL MALIGNANCIES INTOLERANT TO IBRUTINIB and/or acalabrutinib. 2021 European Hematology Association (EHA 2021) Congress in June 2021. Available at EHA Open Access Library.
27- XU W. y col (EP639) ZANUBRUTINIB MONOTHERAPY IN PATIENTS WITH R/R CLL: 34-MONTH FOLLOW-UP RESULTS. 2021 European Hematology Association (EHA2021) Congress in June 2021. Available at EHA Open Access Library.
28- https://www.businesswire.com/news/home/20210729006225/en/BeiGene-Announces-Positive-Topline-Results-from-Phase-3-SEQUOIA-Trial-Comparing-BRUKINSA%C2%AE-Zanubrutinib-to-Bendamustine-Plus-Rituximab-in-Patients-with-Treatment-Na%C3%AFve-Chronic-Lymphocytic-Leukemia.
29- Tam CS, Robak T, Ghia P y col. Zanubrutinib monotherapy for patients with treatment naïve CLL and 17p deletion. Haematologica. 2020 Oct13; Online ahead of print.
30- Brown JR, Robak T, Ghia P y col. Efficacy and safety of zanubrutinib in patients with Treatment-Naïve CLL/SLL with del (17p): follow-up results from arm C of the SEQUOIA (BGB-3111- 304) trial. Blood. 2020;136(Supplement 1):11–12.
31- Tam CS, Flinn IW, Tedeschi A, y col. Zanubrutinib in combination with venetoclax for patients with treatment-naïve CLL/SLL and del(17p): arm D of the SEQUOIA (BGB-3111-304) trial. Blood. 2020;136(Supplement 1):24–25.
32- Hillmen P, Eichhorst B, Brown J y col. (LB1900) FIRST INTERIM ANALYSIS OF ALPINE STUDY: RESULTS OF A PHASE 3 RANDOMIZED STUDY OF ZANUBRUTINIB VS IBRUTINIB IN PATIENTS WITH R/R CLL/SLL. 2021 European Hematology Association (EHA2021) Congress in June 2021. Available at EHA Open Access Library.
33- Tam C, Opat S, D´Sa S y col. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström Macroglobulinemia: the ASPEN study. Blood 2020; 136 (18): 2038–2050.
34- Castillo, J., y col. (EP805) EFFICACY AND SAFETY OF ZANUBRUTINIB VERSUS RITUXIMAB-BASED CHEMOIMMUNOTHERAPY IN WALDENSTRÖM MACROGLOBULINEMIA: MATCHING-ADJUSTED INDIRECT COMPARISONS. 2021 European Hematology Association (EHA2021) Congress in June 2021. Available at EHA Open Access Library.
35- NCCN CLL/SLL. Version 2.2021. https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Published Dec 3, 2020. Accessed Jan 8, 2021.
36- Stephens D. Second-Generation BTK Inhibitors: Simply the Best Treatments for CLL?. Publicado en ascopubs.org/journal/jco on July 26, 2021.
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