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Акалабрутиниб в терапии хронического лимфолейкоза: обзор актуальных данных
Петренко А.А., Кислова М.И., Дмитриева Е.А., Никитин Е.А. Акалабрутиниб в терапии хронического лимфолейкоза: обзор актуальных данных. Современная Онкология. 2021; 23 (2): 332–338.
DOI: 10.26442/18151434.2021.2.200957
DOI: 10.26442/18151434.2021.2.200957
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Petrenko AA, Kislova MI, Dmitrieva EA, Nikitin EA. Acalabrutinib in the treatment of chronic lymphocytic leukemia: a review of recent evidence. Journal of Modern Oncology. 2021; 23 (2): 332–338.
DOI: 10.26442/18151434.2021.2.200957
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Аннотация
В последнее время в связи с разработкой лекарств, мишенью которых являются звенья сигнального пути В-клеточного рецептора (B-cell receptor – BCR), существенно изменились подходы к терапии хронического лимфолейкоза (ХЛЛ). В 2020 г. в Российской Федерации для лечения пациентов с ХЛЛ одобрен акалабрутиниб, ингибитор тирозинкиназы Брутона II поколения. Акалабрутиниб разработан как более селективный ингибитор тирозинкиназы Брутона по сравнению с ибрутинибом. Данный препарат нацелен на уменьшение ограничивающих применение ибрутиниба нежелательных явлений, таких как фибрилляция предсердий и кровотечения. Многоцентровые исследования I/II фазы продемонстрировали эффективность и безопасность монотерапии акалабрутинибом у пациентов с ХЛЛ, ранее не получавших лечение, и у пациентов с рефрактерным/рецидивирующим ХЛЛ, а также непереносимостью ибрутиниба. Исследования III фазы, ASCEND и ELEVATE-TN, сравнивали монотерапию акалабрутинибом или комбинацию акалабрутиниба и обинутузумаба со стандартными методами лечения и продемонстрировали бóльшую эффективность и лучшую переносимость акалабрутиниба. Ко времени написания обзора продолжалось исследование III фазы – сравнение акалабрутиниба и монотерапии ибрутинибом (ELEVATE-RR). Результаты этого исследования и данные реальной клинической практики помогут прояснить оптимальное использование акалабрутиниба в лечении ХЛЛ.
Ключевые слова: акалабрутиниб, ибрутиниб, ингибиторы тирозинкиназы Брутона, таргетные препараты, хронический лимфолейкоз, фибрилляция предсердий, кровотечение
Ключевые слова: акалабрутиниб, ибрутиниб, ингибиторы тирозинкиназы Брутона, таргетные препараты, хронический лимфолейкоз, фибрилляция предсердий, кровотечение
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Chronic lymphocytic leukemia (CLL) treatment landscape has changed dramatically with the recently developed drugs targeting the B-cell receptor (BCR) signalling pathway. Acalabrutinib, a second generation Bruton tyrosine kinase inhibitor, was approved in 2020 in Russia for the treatment of patients with CLL. Acalabrutinib was developed as a more selective Bruton tyrosine kinase inhibitor then ibrutinib. This drug is aimed at reducing the adverse events that limit the use of ibrutinib, such as atrial fibrillation and bleeding. Phase I/II multicenter studies have demonstrated the efficacy and safety of acalabrutinib monotherapy in untreated CLL patients and in patients with relapsed/refractory CLL and ibrutinib intolerance. Phase III trials, ASCEND and ELEVATE-TN, compared acalabrutinib monotherapy and a combination of acalabrutinib and obinutuzumab versus standard therapies and demonstrated improved efficacy and tolerability of acalabrutinib. A phase III trial comparing acalabrutinib and ibrutinib monotherapy (ELEVATE-RR) is ongoing. The results of this study along with real-life clinical data could determine the place of acalabrutinib in CLL treatment.
Keywords: acalabrutinib, ibrutinib, Bruton tyrosine kinase inhibitors, target agents, chronic lymphocytic leukemia, atrial fibrillation, bleeding
Полный текст
Список литературы
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17. Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9:21. DOI:10.1186/s13045-016-0250-9
18. Barf T, Covey T, Izumi R, et al. Acalabrutinib (ACP-196): A Covalent Bruton Tyrosine Kinase Inhibitor with a Differentiated Selectivity and In Vivo Potency Profile. J Pharmacol Exp Ther. 2017;363(2):240-52. DOI:10.1124/jpet.117.242909
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20. Ghia P, Pluta A, Wach M, et al. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020;38(25):2849-61. DOI:10.1200/JCO.19.03355
21. Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020;395(10232):1278-91. DOI:10.1016/S0140-6736(20)30262-2. Erratum in: Lancet. 2020;395(10238):1694.
22. Buggy JJ, Elias L. Bruton tyrosine kinase (BTK) and its role in B-cell malignancy. Int Rev Immunol. 2012;31(2):119-32. DOI:10.3109/08830185.2012.664797. Erratum in: Int Rev Immunol. 2012;31(5):428.
23. Hendriks RW, Bredius RG, Pike-Overzet K, Staal FJ. Biology and novel treatment options for XLA, the most common monogenetic immunodeficiency in man. Expert Opin Ther Targets. 2011;15(8):1003-21. DOI:10.1517/14728222.2011.585971
24. Alinari L, Quinion C, Blum KA. Bruton’s tyrosine kinase inhibitors in B-cell non-Hodgkin’s lymphomas. Clin Pharmacol Ther. 2015;97(5):469-77. DOI:10.1002/cpt.65
25. Chiorazzi N, Ferrarini M. B cell chronic lymphocytic leukemia: lessons learned from studies of the B cell antigen receptor. Annu Rev Immunol. 2003;21:841-94. DOI:10.1146/annurev.immunol.21.120601.141018
26. Küppers R. Mechanisms of B-cell lymphoma pathogenesis. Nat Rev Cancer. 2005;5(4):251-62. DOI:10.1038/nrc1589. PMID: 15803153
27. Byrd JC, Harrington B, O’Brien S, et al. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374(4):323-32. DOI:10.1056/NEJMoa1509981
28. 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):13075-80. DOI:10.1073/pnas.1004594107
29. Patel V, Balakrishnan K, Bibikova E, et al. Comparison of Acalabrutinib, A Selective Bruton Tyrosine Kinase Inhibitor, with Ibrutinib in Chronic Lymphocytic Leukemia Cells. Clin Cancer Res. 2017;23(14):3734-43. DOI:10.1158/1078-0432.CCR-16-1446
30. Series J, Garcia C, Levade M, et al. Differences and similarities in the effects of ibrutinib and acalabrutinib on platelet functions. Haematologica. 2019;104(11):2292-9. DOI:10.3324/haematol.2018.207183
31. AstraZeneca Pharmaceuticals LP. Calquence approved in the US for adult patients with chronic lymphocytic leukaemia [press release]; [cited 2019 December 17]. Available at: https://www.astrazeneca.com/media-centre/press-releases/2019/calquence-approved-in-the-us-for-adult-.... Accessed: 04.03.2021.
32. Byrd JC, Wierda WG, Schuh A, et al. Acalabrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia: updated phase 2 results. Blood. 2020;135(15):1204-13. Available at: https://pubmed.ncbi.nlm.nih.gov/
?term=Byrd+JC%2C+Wierda+WG%2C+Schuh+A%2C+et+al.+Acalabrutinib+monotherapy+in+patients+with+relapsed%2Frefractory+chronic+lymphocytic+leukemia%3A+updated+phase+2+results.+Blood.+2020%3B135%2815%29%3A1204-13&filter=simsearch1.fha&filter=simsearch2.ffrft&filter=simsearch3.fft&filter=
pubt.clinicaltrial&filter=pubt.meta-analysis&filter=pubt.systematicreview. Accessed: 04.03.2021.
33. Awan FT, Schuh A, Brown JR, et al. Acalabrutinib monotherapy in patients with chronic lymphocytic leukemia who are intolerant to ibrutinib. Blood Adv. 2019;3(9):1553-62. DOI:10.1182/bloodadvances.2018030007
34. Byrd JC, WoyachJA, Furman RR, et al. Acalabrutinib in treatment-naive chronic lymphocytic leukemia: Mature results from phase II study demonstrating durable remissions and long-term tolerability. J Clin Oncol. 2020;38(15 suppl.):8024. DOI:10.1200/JCO.2020.38.15_suppl.8024
35. Rogers KA, Thompson PA, Allan JN, et al. Phase 2 study of acalabrutinib in ibrutinib (IBR)-intolerant patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). J Clin Oncol. 2019;37(15 suppl.):7530. DOI:10.1200/JCO.2019.37.15_suppl.7530
36. Woyach JA, Blachly JS, Rogers KA, et al. Acalabrutinib plus Obinutuzumab in Treatment-Naive and Relapsed/Refractory Chronic Lymphocytic Leukemia. Cancer Discov. 2020;10(3):394-405. DOI:10.1158/2159-8290.CD-19-1130
37. Woyach JA, Ruppert AS, Heerema NA, et al. Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL. N Engl J Med. 2018;379(26):2517-28. DOI:10.1056/NEJMoa1812836
38. Moreno C, Greil R, Demirkan F, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20(1):43-56. DOI:10.1016/S1470-2045(18)30788-5
39. Byrd, J et al. First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia. Abstract #7500 Oral Abstract Session Hematologic Malignancies 7 June 2021.
40. Brown JR, Eichhorst BF, Ghia P, et al. A phase 3 trial comparing the efficacy and safety of acalabrutinib in combination with venetoclax with or without obinutuzumab, compared with investigator’s choice of chemoimmunotherapy in patients with previously untreated chronic lymphocytic leukemia (CLL) without Del(17p) or TP53 mutation. Blood. 2019;134(Suppl. 1):4318.
41. Lampson B, Tyekucheva S, Crombie J, et al. Preliminary safety and efficacy results from a phase 2 study of acalabrutinib, venetoclax and obinutuzumab in patients with previously untreated chronic lymphocytic leukemia (CLL). Blood. 2019;134(Suppl. 1):32.
42. Byrd JC, Owen R, O’Brien SM, et al. Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in hematologic malignancies. Blood. 2017;130(Suppl. 1):4326.
43. 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. DOI:10.1056/NEJMoa1215637
44. Stephens DM, Byrd JC. How I manage ibrutinib intolerance and complications in patients with chronic lymphocytic leukemia. Blood. 2019;133(12):1298-307. DOI:10.1182/blood-2018-11-846808
45. Shafaattalab S, Lin E, Christidi E, et al. Ibrutinib Displays Atrial-Specific Toxicity in Human Stem Cell-Derived Cardiomyocytes. Stem Cell Reports. 2019;12(5):996-1006. DOI:10.1016/j.stemcr.2019.03.011
46. Salem JE, Manouchehri A, Bretagne M, et al. Cardiovascular toxicities associated with ibrutinib. J Am Coll Cardiol. 2019;74(13):1667-8.
47. Furman RR, Byrd JC, Owen RG, et al. Safety of acalabrutinib (Acala) monotherapy in hematologic malignancies: pooled analysis from clinical trials. J Clin Oncol. 2020;38(Suppl. 15):8064.
48. Lipsky A, Lamanna N. Managing toxicities of Bruton tyrosine kinase inhibitors. Hematology Am Soc Hematol Educ Program. 2020;2020(1):336-45. DOI:10.1182/hematology.2020000118
49. In an interview with Targeted Oncology, Jeff P. Sharman, MD, discussed the updated ELEVATE-TN data and ongoing research that is poised to define the optimal role of acalabrutinib in CLL at the 2019 ASH Annual Meeting.
50. Ed. Byrd JC, Woyach JA, Furman RR, et al. Acalabrutinib in treatment-naive chronic lymphocytic leukemia: mature results from phase 2 Study demonstrating durable remissions and long-term tolerability. Vol. 294983.Virtual Edition of the 25th European Hematology Association Annual Meeting. EHA Library, 2020. P. S163.
________________________________________________
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34. Byrd JC, WoyachJA, Furman RR, et al. Acalabrutinib in treatment-naive chronic lymphocytic leukemia: Mature results from phase II study demonstrating durable remissions and long-term tolerability. J Clin Oncol. 2020;38(15 suppl.):8024. DOI:10.1200/JCO.2020.38.15_suppl.8024
35. Rogers KA, Thompson PA, Allan JN, et al. Phase 2 study of acalabrutinib in ibrutinib (IBR)-intolerant patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). J Clin Oncol. 2019;37(15 suppl.):7530. DOI:10.1200/JCO.2019.37.15_suppl.7530
36. Woyach JA, Blachly JS, Rogers KA, et al. Acalabrutinib plus Obinutuzumab in Treatment-Naive and Relapsed/Refractory Chronic Lymphocytic Leukemia. Cancer Discov. 2020;10(3):394-405. DOI:10.1158/2159-8290.CD-19-1130
37. Woyach JA, Ruppert AS, Heerema NA, et al. Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL. N Engl J Med. 2018;379(26):2517-28. DOI:10.1056/NEJMoa1812836
38. Moreno C, Greil R, Demirkan F, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20(1):43-56. DOI:10.1016/S1470-2045(18)30788-5
39. Byrd, J et al. First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia. Abstract #7500 Oral Abstract Session Hematologic Malignancies 7 June 2021.
40. Brown JR, Eichhorst BF, Ghia P, et al. A phase 3 trial comparing the efficacy and safety of acalabrutinib in combination with venetoclax with or without obinutuzumab, compared with investigator’s choice of chemoimmunotherapy in patients with previously untreated chronic lymphocytic leukemia (CLL) without Del(17p) or TP53 mutation. Blood. 2019;134(Suppl. 1):4318.
41. Lampson B, Tyekucheva S, Crombie J, et al. Preliminary safety and efficacy results from a phase 2 study of acalabrutinib, venetoclax and obinutuzumab in patients with previously untreated chronic lymphocytic leukemia (CLL). Blood. 2019;134(Suppl. 1):32.
42. Byrd JC, Owen R, O’Brien SM, et al. Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in hematologic malignancies. Blood. 2017;130(Suppl. 1):4326.
43. 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. DOI:10.1056/NEJMoa1215637
44. Stephens DM, Byrd JC. How I manage ibrutinib intolerance and complications in patients with chronic lymphocytic leukemia. Blood. 2019;133(12):1298-307. DOI:10.1182/blood-2018-11-846808
45. Shafaattalab S, Lin E, Christidi E, et al. Ibrutinib Displays Atrial-Specific Toxicity in Human Stem Cell-Derived Cardiomyocytes. Stem Cell Reports. 2019;12(5):996-1006. DOI:10.1016/j.stemcr.2019.03.011
46. Salem JE, Manouchehri A, Bretagne M, et al. Cardiovascular toxicities associated with ibrutinib. J Am Coll Cardiol. 2019;74(13):1667-8.
47. Furman RR, Byrd JC, Owen RG, et al. Safety of acalabrutinib (Acala) monotherapy in hematologic malignancies: pooled analysis from clinical trials. J Clin Oncol. 2020;38(Suppl. 15):8064.
48. Lipsky A, Lamanna N. Managing toxicities of Bruton tyrosine kinase inhibitors. Hematology Am Soc Hematol Educ Program. 2020;2020(1):336-45. DOI:10.1182/hematology.2020000118
49. In an interview with Targeted Oncology, Jeff P. Sharman, MD, discussed the updated ELEVATE-TN data and ongoing research that is poised to define the optimal role of acalabrutinib in CLL at the 2019 ASH Annual Meeting.
50. Ed. Byrd JC, Woyach JA, Furman RR, et al. Acalabrutinib in treatment-naive chronic lymphocytic leukemia: mature results from phase 2 Study demonstrating durable remissions and long-term tolerability. Vol. 294983.Virtual Edition of the 25th European Hematology Association Annual Meeting. EHA Library, 2020. P. S163.
Авторы
А.А. Петренко*1,2, М.И. Кислова3,4, Е.А. Дмитриева1, Е.А. Никитин1,2
1 ГБУЗ «Городская клиническая больница им. С.П. Боткина» Департамента здравоохранения г. Москвы, Москва, Россия;
2 ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
3 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
4 ФГБУ «Национальный медицинский исследовательский центр гематологии» Минздрава России, Москва, Россия
*petrenkoandrei13@gmail.com
1 ГБУЗ «Городская клиническая больница им. С.П. Боткина» Департамента здравоохранения г. Москвы, Москва, Россия;
2 ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
3 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
4 ФГБУ «Национальный медицинский исследовательский центр гематологии» Минздрава России, Москва, Россия
*petrenkoandrei13@gmail.com
________________________________________________
Andrei A. Petrenko*1,2, Maria I. Kislova3,4, Elena A. Dmitrieva1, Eugene A. Nikitin1,2
1 Botkin City Clinical Hospital, Moscow, Russia;
2 Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
3 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
4 National Research Center for Hematology, Moscow, Russia
*petrenkoandrei13@gmail.com
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