Klinická farmakologie a farmacie – 3/2021

KLINICKÁ FARMAKOLOGIE A FARMACIE / Klin Farmakol Farm 2021; 35(3): 56–60 / www.klinickafarmakologie.cz 60 HLAVNÍ TÉMA Léčba pacientů přípravkem buněčné terapie axikabtagen ciloleucel Literatura 1. Friedberg JW. Relapsed/refractory diffuse large B‑cell lym‑ phoma. Hematology Am Soc Hematol Educ Program 2011; 2011(1): 498–505. 2. Crump M, Neelapu SS, Farooq U et al. Outcomes in refracto‑ ry diffuse large B‑cell lymphoma: results from the interna‑ tional SCHOLAR-1 study. Blood 2017; 130(16): 1800–1808. 3. Polgárová K, Trněný M. Imunoterapie v léčbě lymfomů. Postgraduální medicína 2020; 22(1): 9–18. 4. Agresivní lymfomy. In: Belada D, Trněný M (editoři). Dia‑ gnostické a léčebné postupy u nemocných s lymfomy, XI. vydání. KAP CZ Brno 2020: 97–102. 5. Ross J, Carver ML. MediaKite announces Yescarta® CAR T­ ‑cell therapy improved event‑free survival by 60% over che‑ motherapy plus stem cell transplant in second‑line relapsed or refractory large B‑cell lymphoma [online]. 2021 [cit. 2021- 10-11]. Dostupné z: https://www.businesswire.com/news/ home/20210628005449/en/ 6. Lee DW, Santomasso BD, Locke FL et al. ASTCT consensus grading for cytokine release syndrome and neurologic toxi‑ city associated with immune effector cells. Biol Blood Ma‑ rrow Transplant 2019; 25: 625–638. 7. Yakoub‑Agha I, Chabannon C, Bader P et al. Management of adults and children undergoing chimeric antigen recep‑ tor T‑cell therapy: best practice recommendations of the Eu‑ ropean society for blood and marrow transplantation (EBMT) and the Joint accreditation committee of ISCT and EBMT (JA‑ CIE). Haematologica 2020; 105(2): 297–316. 8. Yescarta, Souhrn údajů o přípravku, verze z 22. 6. 2020. 9. Neelapu SS, Locke FL, Bartlett NL et al. Axicabtagene cilo‑ leucel CAR T‑cell therapy in refractory large B‑cell lympho‑ ma. N Engl J Med 2017; 377: 2531–2544. 10. Locke FL, Ghobadi A, Jacobson CA et al. Long‑term safe‑ ty and activity of axicabtagene ciloleucel in refractory large B‑cell lymphoma (ZUMA-1): a single‑arm, multicentre, pha‑ se 1–2 trial. Lancet Oncol 2019; 20: 31–42. 11. Jacobson C, Chavez JC, Sehgal AR et al. Primary analy‑ sis of Zuma-5: A phase 2 study of axicabtagene ciloleucel (axi‑cel) in patients with relapsed/refractory (R/R) indolent non‑Hodgkin lymphoma (iNHL). Blood 2020; 136(Supple‑ ment 1): 40–41. 12. Jacobson CA, Westin JR, Miklos DB et al. Phase 1/2 prima‑ ry analysis of ZUMA-6: Axicabtagene ciloleucel (Axi‑Cel) in combination with atezolizumab (Atezo) for the treatment of patients (Pts) with refractory diffuse large B cell lymphoma (DLBCL). Cancer Res 2020; 80(16 Suppl): Abstract nr CT055. 13. Oluwole OO, Bishop MR, Gisselbrecht C et al. ZUMA-7: A phase 3 randomized trial of axicabtagene ciloleucel (Axi­ ‑Cel) versus standard‑of‑care (SOC) therapy in patients with relapsed/refractory diffuse large B cell lymphoma (R/R DLB‑ CL). J Clin Oncol 2018; 36(15_suppl): TPS7585. 14. Jacobson CA, Locke FL, Miklos DB et al. Outcomes of patients (Pts) in ZUMA-9, a multicenter, open‑label study of axicabtagene ciloleucel (Axi‑cel) in relapsed/refractory large B cell lymphoma (R/R LBCL) for expanded access and commercial out‑of‑specification (OOS) product. Blood 2020; 136(Supplement 1): 2–3. 15. Reshef R, Miklos DB, Timmerman JM et al. ZUMA-11: A pha‑ se 1/2 multicenter study of axicabtagene ciloleucel (Axi‑cel) + utomilumab patients with refractory large B cell lympho‑ ma. Blood 2019; 134(Supplement_1): 4084. 16. Neelapu SS, Dickinson M, Ulrickson ML et al. Interim Ana‑ lysis of ZUMA-12: A phase 2 study of axicabtagene ciloleu‑ cel (Axi‑cel) as first‑line therapy in patients (Pts) with high­ ‑risk large B cell lymphoma (LBCL). Blood 2020; 136(Supple‑ ment 1): 49. 17. Neelapu SS, Kharfan‑Dabaja MA, Oluwole OO et al. A pha‑ se 2, open‑label, multicenter study evaluating the safety and efficacy of axicabtagene ciloleucel in combination with either rituximab or lenalidomide in patients with refractory large B‑cell lymphoma (ZUMA-14). Blood 2019; 134(Supple‑ ment_1): 4093. 18. Catlett G, Lada A. Humanigen reports positive data with lenzilumab in the ZUMA-19 CAR‑T phase 1 b study in DLBCL and plans to initiate a potential registrational study [online]. 2021 [cit. 2021-10-11]. Dostupné z: https://www.businesswi‑ re.com/news/home/20210419005250/en/ 19. Jacobson CA, Hunter B, Armand P et al. Axicabtagene cilo‑ leucel in the real world: outcomes and predictors of respon‑ se, resistance and toxicity. Blood 2018; 132(Supplement 1): 92. 20. Jacobson CA, Hunter BR, Redd R et al. Axicabtagene ci‑ loleucel in the non‑trial setting: outcomes and correlates of response, resistance, and toxicity. J Clin Oncol 2020; 38: 3095–3106. 21. Nastoupil LJ, Jain MD, Feng L et al. Standard‑of‑care axi‑ cabtagene ciloleucel for relapsed or refractory large B‑cell lymphoma: results from the US lymphoma CAR T consorti‑ um. J Clin Oncol 2020; 38: 3119–3128. 22. Vercellino L, Di Blasi R, Kanoun S et al. Predictive factors of early progression after CAR T‑cell therapy in relapsed/ refractory diffuse large B‑cell lymphoma. Blood Adv 2020; 4(22): 5607–5615. 23. Bethge WA, Holtick U, Wagner‑Drouet EM, et al. Standard­ ‑of‑care CAR‑T cell therapy for large B‑cell lymphoma: real world data Germany. EBMT annual meeting 2021, abstract AA2–2. 24. Folber F. Update ZUMA-1 (4leté sledování ) a dlouho‑ dobé zkušenosti s léčbou přípravkem Yescarta v ČR a v za‑ hraničí. II. Český hematologický a transfuziologický sjezd, 13. 9. 2021, Olomouc. 25. Wang M, Munoz J, Goy A et al. KTE‑X19 CAR T‑cell thera‑ py in relapsed or refractory mantle‑cell lymphoma. N Engl J Med 2020; 382: 1331–1342. 26. Shah BD, Bishop MR, Oluwole OO et al. End of phase I re‑ sults of ZUMA-3, a phase 1/2 study of KTE‑X19, anti‑CD19 chi‑ meric antigen receptor (CAR) T cell therapy, in adult patients (pts) with relapsed/refractory (R/R) acute lymphoblastic leu‑ kemia (ALL). J Clin Oncol 2019; 37(15_suppl): 7006.