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

Overall survival in the ~4-year analysis of ZUMA-31,2

42% alive at 4 years (OS rate KM estimate)1

Chart showing that 46% of the participants were alive at 3 years. Chart showing that 46% of the participants were alive at 3 years.

Tick marks represent censored patients. Subjects who have not died by the analysis data cut-off date will be censored at their last contact date.2

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Median OS was not reached in patients who achieved CR+CRi (95% CI, 25.4-NE)1

  • In the primary analysis, mOS was 18.2 months (95% CI: 14.2, NE), and the estimated 1-year OS rate was 71% (95% CI: 56, 81) at a median study follow-up of 15.5 months3
  • The ~4-year OS analysis* included patients who subsequently received allo-SCT (n=11) and who started new anti-cancer therapy (n=6). The KM estimate of OS at 4 years was 42% (n=54; 95% CI: 28, 55). The KM mOS was 26.0 months (n=54; 95% CI: 16.2, NE). Median follow-up time (reverse KM approach) for OS was 42.4 months (n=54; 95% CI: 41.2, 45.8).1,4
  • OS was a secondary endpoint of the ZUMA-3 phase 2, single-arm, open-label study and was not the primary objective of the study5
  • OS data are not included in the USPI. OS data are descriptive and should be carefully interpreted in light of the single-arm design
NCCN RECOMMENDED

Brexucabtagene autoleucel (TECARTUS®) is recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for adult patients with R/R B-cell ALL6:

  • Listed as a preferred regimen for patients with R/R Ph- B-cell ALL only (category 2A)
  • Listed as an other recommended regimen for patients with R/R Ph+ B-cell ALL following therapy that has included TKIs (category 2A)

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

ALL=acute lymphoblastic leukemia; allo-SCT=allogeneic stem cell transplant; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete hematologic recovery; KM=Kaplan-Meier; mOS=median overall survival; NCCN=National Comprehensive Cancer Network; NE=not estimable; OS=overall survival; Ph=Philadelphia chromosome; R/R=relapsed or refractory; TKI=tyrosine kinase inhibitor; USPI=US Prescribing Information.

References: 1. Data on file [1]. Kite Pharma, Inc; 2023. 2. Data on file [2]. Kite Pharma, Inc; 2023. 3. Data on file. Kite Pharma, Inc; 2021. 4. Data on file. Kite Pharma, Inc; 2024. 5. 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. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed August 8, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.

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