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Home / Efficacy / ZUMA-3 Pivotal Trial

In adult patients with R/R B-cell precursor ALL

ZUMA-3: a phase 2, single-arm, open-label, international, multicenter trial1,2

ZUMA-3 is the largest adult-only study of a CAR T-cell therapy for R/R B-cell precursor ALL to date1,2

ZUMA-3 trial design including patient population and treatment arms ZUMA-3 trial design including patient population and treatment arms
  • 54 of the 55 treated patients were evaluable for efficacy (mITT population)1
  • Sixteen patients who were leukapheresed did not receive TECARTUS for one of the following reasons1:
    • Six patients did not receive TECARTUS due to manufacturing failure
    • Eight patients did not receive TECARTUS due to AEs following leukapheresis
    • Two patients received lymphodepleting chemotherapy but were not treated with TECARTUS
    • One patient treated with TECARTUS was inevaluable for efficacy

Key inclusion criteria1-3

  • Patients were aged 18 years and older
  • R/R B-cell precursor ALL, defined as one of the following:
    • Primary refractory disease
    • First relapse following a remission lasting
      ≤ 12 months
    • R/R following > 2 lines of prior therapy
    • R/R ≥ 100 days after allo-SCT
  • Ph+ patients allowed if intolerant to TKI, or if R/R disease despite 2 different TKIs

Key exclusion criteria1,3

  • Diagnosis of Burkitt leukemia/lymphoma
  • Active or serious infections
  • Active graft-vs-host disease or taking immunosuppressive medications within 4 weeks prior to enrollment
  • Any history of CNS disorders including CNS-2 disease with neurologic changes and CNS-3 disease irrespective of neurological changes

*All treated patients received a lymphodepleting regimen that consisted of fludarabine 25 mg/m2 intravenously on the fourth, third, and second day and cyclophosphamide 900 mg/m2 on the second day before receiving TECARTUS.1

TECARTUS was studied in adult patients with R/R B-cell precursor ALL—
a historically difficult-to-treat population1,4,5

Table showing baseline patient characteristics in all treated patients (N=55) Table showing baseline patient characteristics in all treated patients (N=55)

42% of patients in ZUMA-3 were relapsed or refractory following allo-SCT2

AEs=adverse events; ALL=acute lymphoblastic leukemia; allo-SCT=allogeneic stem cell transplant; CAR=chimeric antigen receptor; CNS=central nervous system; CR=complete remission; CRi=complete remission with incomplete hematologic recovery; DOR=duration of remission; ECOG PS=Eastern Cooperative Oncology Group performance status; IQR=interquartile range; ITT=intent-to-treat; IV=intravenous; mITT=modified intent-to-treat; MRD=minimal residual disease; OS=overall survival; Ph=Philadelphia chromosome; RFS=relapse-free survival; R/R=relapsed or refractory; TKI=tyrosine kinase inhibitor.

References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. Shah BD, Ghobadi A, Oluwole OO, et al. KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study. Lancet. 2021;398(10299):491-502. 3. Shah BD, Ghobadi A, Oluwole OO, et al. KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study – supplementary appendix. Lancet. Published online June 4, 2021. doi:10.1016/S0140-6736(21)01222-8 4. Gökbuget N, Dombret H, Ribera JM, et al. International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia. Haematologica. 2016;101(12):1524-1533. 5. Kantarjian HM, Thomas D, Ravandi F, et al. Defining the course and prognosis of adults with acute lymphocytic leukemia in first salvage after induction failure or short first remission duration. Cancer. 2010;116(24):5568-5574. 6. Data on file[1]. Kite Pharma, Inc; 2021. 7. Data on file [2]. Kite Pharma, Inc; 2021.

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