Pivotal study design 1,4

71

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

55

patients received
lymphodepleting chemotherapy
and 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 lymphodepleting chemotherapy and 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)1
  • 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 TECARTUS1

Key inclusion criteria

  • Patients were aged 18 years and older4
  • 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-SCT1

Key exclusion criteria1

  • 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 population1,5

Selected baseline patient characteristics: high-risk features were common in the ZUMA-3 population4,6†

Patients with high-risk characteristics were enrolled in the registration trial4,7

These characteristics were deemed high-risk in the ZUMA-3 trial.4,7 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. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. 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. Published online December 10, 2022. doi:10.1186/s13045-022-01379-0 3. Wang M, Munoz J, Goy A, et al. Three-year follow-up of KTE-X19 in patients with relapsed/refractory mantle cell lymphoma, including high-risk subgroups, in the ZUMA-2 study. J Clin Oncol. 2023;41(3):555-567. 4. 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. 5. 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. 6. Data on file. Kite Pharma, Inc; 2023. 7. DeAngelo DJ, Jabbour E, Advani A. Recent advances in managing acute lymphoblastic leukemia. Am Soc Clin Oncol Educ Book. 2020;40:330-342.