Investigating the Influence of Covariates on Axicabtagene Ciloleucel (axi-cel) Kinetics in Patients with Non-Hodgkin’s Lymphoma

US FDA. US prescribing information: Yescarta (axicabtagene ciloleucel). Santa Monica (CA): Kite Pharma, Inc; 2022. Available from: https://www.fda.gov/media/108377/download. Accessed 31 Jan 2023.

King AC, Orozco JS. Axicabtagene ciloleucel: the first FDA-approved CAR T-cell therapy for relapsed/refractory large B-cell lymphoma. J Adv Pract Oncol. 2019;10:878–82.

PubMed  PubMed Central  Google Scholar 

Westin JR, Kersten MJ, Salles G, Abramson JS, Schuster SJ, Locke FL, et al. Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: observations from the JULIET, ZUMA-1, and TRANSCEND trials. Am J Hematol. 2021;96:1295–312.

Article  PubMed  PubMed Central  Google Scholar 

Wang K, Wei G, Liu D. CD19: a biomarker for B cell development, lymphoma diagnosis and therapy. Exp Hematol Oncol. 2012;1:36.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Sadelain M, Brentjens R, Rivière I. The basic principles of chimeric antigen receptor design. Cancer Discov. 2013;3:388–98.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, et al. Phase 1 results of ZUMA-1: a multicenter study of KTE-C19 Anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther J Am Soc Gene Ther. 2017;25:285–95.

Article  CAS  Google Scholar 

Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377:2531–44.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jacobson CA, Chavez JC, Sehgal AR, William BM, Munoz J, Salles G, et al. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022;23:91–103.

Article  CAS  PubMed  Google Scholar 

Locke FL, Miklos DB, Jacobson CA, Perales M-A, Kersten M-J, Oluwole OO, et al. Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma. N Engl J Med. 2022;386:640–54.

Article  CAS  PubMed  Google Scholar 

Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1–2 trial. Lancet Oncol. 2019;20:31–42.

Article  CAS  PubMed  Google Scholar 

Neelapu SS, Jacobson CA, Ghobadi A, Miklos DB, Lekakis LJ, Oluwole OO, et al. 5-Year follow-up supports curative potential of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1). Blood. 2023; p. blood.2022018893.

Westin JR, Oluwole OO, Kersten MJ, Miklos DB, Perales M-A, Ghobadi A, et al. Survival with axicabtagene ciloleucel in large B-cell lymphoma. N Engl J Med. 2023;389:148–57.

Article  CAS  PubMed  Google Scholar 

Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014;124:188–95.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Sterner RC, Sterner RM. CAR-T cell therapy: current limitations and potential strategies. Blood Cancer J. 2021;11:69.

Article  PubMed  Google Scholar 

Tallantyre EC, Evans NA, Parry-Jones J, Morgan MPG, Jones CH, Ingram W. Neurological updates: neurological complications of CAR-T therapy. J Neurol. 2021;268:1544–54.

Article  PubMed  Google Scholar 

US Food and Drug Administration. Center for Biologics Evaluation and Research. Considerations for the development of chimeric antigen receptor (CAR) T cell products. Draft guidance for industry. 2022. Available from: https://www.fda.gov/media/156896/download. Accessed 2 Jul 2023.

European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products. EMEA/149995/2008 rev.1.; 2018. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-safety-efficacy-follow-risk-management-advanced-therapy-medicinal-products-revision_en.pdf. Accessed 2 Jul 2023.

Locke FL, Rossi JM, Neelapu SS, Jacobson CA, Miklos DB, Ghobadi A, et al. Tumor burden, inflammation, and product attributes determine outcomes of axicabtagene ciloleucel in large B-cell lymphoma. Blood Adv. 2020;4:4898–911.

Article  PubMed  PubMed Central  Google Scholar 

Beal SL. Ways to fit a PK model with some data below the quantification limit. J Pharmacokinet Pharmacodyn. 2001;28:481–504.

Article  CAS  PubMed  Google Scholar 

Savic RM, Karlsson MO. Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J. 2009;11:558–69.

Article  PubMed  PubMed Central  Google Scholar 

Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579–86.

Article  PubMed  Google Scholar 

Strati P, Ahmed S, Furqan F, Fayad LE, Lee HJ, Iyer SP, et al. Prognostic impact of corticosteroids on efficacy of chimeric antigen receptor T-cell therapy in large B-cell lymphoma. Blood. 2021;137:3272–6.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Nguyen THT, Mouksassi M-S, Holford N, Al-Huniti N, Freedman I, Hooker AC, et al. Model evaluation of continuous data pharmacometric models: metrics and graphics. CPT Pharmacomet Syst Pharmacol. 2017;6:87–109.

Article  CAS  Google Scholar 

Bergstrand M, Hooker AC, Wallin JE, Karlsson MO. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 2011;13:143–51.

Article  PubMed  PubMed Central  Google Scholar 

Ogasawara K, Dodds M, Mack T, Lymp J, Dell’Aringa J, Smith J. Population cellular kinetics of lisocabtagene maraleucel, an autologous CD19-directed chimeric antigen receptor T-cell product, in patients with Rrlapsed/refractory large B-cell lymphoma. Clin Pharmacokinet. 2021;60:1621–33.

Article  CAS  PubMed  PubMed Central  Google Scholar 

De Boer RJ, Perelson AS. Quantifying T lymphocyte turnover. J Theor Biol. 2013;327:45–87.

Article  PubMed  PubMed Central  Google Scholar 

Singh AP, Zheng X, Lin-Schmidt X, Chen W, Carpenter TJ, Zong A, et al. Development of a quantitative relationship between CAR-affinity, antigen abundance, tumor cell depletion and CAR-T cell expansion using a multiscale systems PK-PD model. MAbs. 2020;12:1688616.

Article  PubMed  Google Scholar 

Munshi NC, Anderson LD, Shah N, Madduri D, Berdeja J, Lonial S, et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med. 2021;384:705–16.

Article  CAS  PubMed  Google Scholar 

Stein AM, Grupp SA, Levine JE, Laetsch TW, Pulsipher MA, Boyer MW, et al. Tisagenlecleucel model-based cellular kinetic analysis of chimeric antigen receptor-T cells. CPT Pharmacomet Syst Pharmacol. 2019;8:285–95.

Article  CAS  Google Scholar 

Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2020;382:1331–42.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Liu C, Ayyar VS, Zheng X, Chen W, Zheng S, Mody H, et al. Model-based cellular kinetic analysis of chimeric antigen receptor-T cells in humans. Clin Pharmacol Ther. 2021;109:716–27.

Article  CAS  PubMed  Google Scholar 

Mu W, Long X, Cai H, Chen C, Hu G, Lou Y, et al. A model perspective explanation of the long-term sustainability of a fully human BCMA-targeting CAR (CT103A) T-cell immunotherapy. Front Pharmacol. 2022;13: 803693.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Zhang Y, Li J, Lou X, Chen X, Yu Z, Kang L, et al. A prospective investigation of bispecific CD19/22 CAR T cell therapy in patients with relapsed or refractory B cell non-Hodgkin lymphoma. Front Oncol. 2021;11: 664421.

Article  CAS  PubMed 

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