Prescribing Information

Home / Efficacy / ZUMA-3 Pivotal Trial

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

ZUMA-3: the longest follow-up in an adult-only study of a CAR T-cell therapy for R/R B-cell precursor ALL1

Pivotal study design2,3

71

patients with
R/R B-cell ALL enrolled
in ZUMA-3 (ITT)

55

patients received a single IV
infusion of TECARTUS®*

Primary endpoint:

Overall complete remission rate (CR + CRi)

Selected secondary endpoints:

DOR, MRD-negative rate, RFS, OS, and safety

Pivotal study design 1,4

71

patients with R/R B-cell ALL enrolled in ZUMA-3 (ITT)

55

patients received a single IV infusion of TECARTUS®*

Primary endpoint:

Overall complete remission rate (CR + CRi)

Selected secondary endpoints:

DOR,
MRD-negative rate, RFS, OS, and safety

  • 54 of the 55 treated patients were evaluable for efficacy (mITT population)2
  • Sixteen patients who were leukapheresed did not receive TECARTUS: 6 due to manufacturing failure, 8 due to AEs following leukapheresis, and 2 received lymphodepleting chemotherapy but were not treated with TECARTUS2

Key inclusion criteria

  • Patients were aged 18 years and older2,3
  • R/R B-cell precursor ALL, defined as primary refractory disease, first relapse following a remission lasting ≤12 months, R/R following ≥2 lines of prior therapy, or R/R ≥100 days after allo-SCT2

Key exclusion criteria2

  • 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 25 mg/m2 intravenous (IV) fludarabine, 4, 3, and 2 days before infusion, and 900 mg/m2 cyclophosphamide 2 days before infusion while receiving TECARTUS.2

TECARTUS was studied in adult patients with R/R B-cell precursor ALL—
a historically difficult-to-treat population2,4

Selected baseline patient characteristics: high-risk features were common in the ZUMA-3 population3,5†

Patients with high-risk characteristics were enrolled in the registration trial3,5

†These characteristics were deemed high-risk in the ZUMA-3 trial.3,5 Please see the USPI for additional patient characteristics.

AE=adverse event; 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; ITT=intent-to-treat; mITT=modified intent-to-treat; MRD=minimal residual disease; OS=overall survival; Ph=Philadelphia chromosome; RFS=relapse-free survival; R/R=relapsed or refractory; USPI=US Prescribing Information.

References: 1. Shah BD, Ghobadi A, Oluwole OO, et al. Two-year follow-up of KTE-X19 in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia in ZUMA-3 and its contextualization with SCHOLAR-3, an external historical control study. J Hematol Oncol. 2022;15(1):170. 2. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2025. 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. Lancet. 2021;398(10299):491-502. 4. Fulcher J, Leung E, Christou G, Bredeson C, Sabloff M. Selecting the optimal targeted therapy for relapsed B-acute lymphoblastic leukemia. Leuk Lymphoma. 2020;61(9):2271-2273. 5. DeAngelo DJ, Jabbour E, Advani A. Recent advances in managing acute lymphoblastic leukemia. Am Soc Clin Oncol Educ Book. 2020;40:330-342.

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