Prescribing Information

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

TECARTUS® efficacy: deep, durable, and rapid responses were
demonstrated in ZUMA-31,2

Primary analysis1

Overall complete remission rate

65% overall complete remission rate (CR + CRi), with 52% of patients achieving a CR with TECARTUS at a median study follow-up of 12.3 months1,3

Overall complete remission rate graph Overall complete remission rate graph

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  • TECARTUS provided high OCR rates, including patients who were R/R following prior treatment with blinatumomab (OCR rate=56%; n=25) or inotuzumab ozogamicin (OCR rate=67%; n=12), patients who previously relapsed following allo-SCT (OCR rate=70%; n=23), and patients who had primary refractory disease (OCR rate=72%; n=18)3

Responses were rapid3

  • In ZUMA-3, of the 35 patients who achieved CR or CRi, the median time to response was 1.5 months (range: 0.9-3.1 months)
See Survival Data

2-year follow-up analysis

Consistent response rates demonstrated across efficacy analyses1,2,4-6

Response rates in ZUMA-3 trial Response rates in ZUMA-3 trial

*Of the 71 patients who were enrolled (and leukapheresed), 57 patients received lymphodepleting chemotherapy, and 55 patients received TECARTUS. 54 patients were included in the efficacy evaluable population.1

NCCN Clinical Practice Guidelines in Oncology
(NCCN Guidelines®) recommendation
Brexucabtagene autoleucel (TECARTUS) is recommended by the NCCN Guidelines® for adult patients with R/R B-cell ALL7:
  • 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; DOR=duration of remission; NCCN=National Comprehensive Cancer Network; OCR=overall complete remission; Ph=Philadelphia chromosome; R/R=relapsed or refractory; TKIs=tyrosine kinase inhibitors.

References: 1. TECARTUS®; (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. Data on file [1]. Kite Pharma, Inc; 2022. 3. Data on file. Kite Pharma, Inc; 2021. 4. Shah BD, Ghobadi A, Oluwole OO, et al. Two-year follow-up of KTE-X19, an anti-CD19 chimeric antigen receptor T-cell therapy, in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia in ZUMA-3. Abstract 7010. Poster presented at the American Society of Clinical Oncology Annual Meeting; June 2-6, 2022; Chicago, IL. 5. Data on file [2]. Kite Pharma, Inc; 2022. 6. Data on file [3]. Kite Pharma, Inc; 2022. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.1.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed September 1, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.

Duration of remission

TECARTUS delivered a median DOR of 18.6 months (95% CI: 9.4, NE) with a
median study follow-up of 26.8 months2,3

  • DOR was a secondary endpoint of the ZUMA-3 phase 2, single-arm, open-label study1,4
  • DOR data are descriptive and should be carefully interpreted in light of the single-arm study design. DOR data from the 2-year analysis are not included in the USPI
  • 2-year follow-up analysis was conducted in the 54 efficacy-evaluable patients treated with TECARTUS in the ZUMA-3 study. The KM estimate for the updated analysis mDOR was 18.6 months (95% CI: 9.4, NE) for the median follow-up of 26.8 months in patients with an objective response (n=35)2,3
Median DOR in patients with censoring at allo-SCT at a median study follow-up of 20.0 months Median DOR in patients with censoring at allo-SCT at a median study follow-up of 20.0 months

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Primary analysis

  • At a median study follow-up of 12.3 months, the median DOR was 13.6 months in both efficacy-evaluable patients (n=54, 95% CI: 9.4, NE) and in all leukapheresed patients (n=71, 95% CI: 8.7, NE)1
    • Median DOR was not reached in patients with a CR (95% CI: 9.6, NE) in efficacy-evaluable patients (n=54) and was 13.6 months (95% CI: 9.4, NE) in all leukapheresed patients (n=71)
    • Median DOR was 8.7 months in patients with a CRi (95% CI: 1.0, NE) in both efficacy-evaluable patients (n=54) and all leukapheresed patients (n=71)
    • DOR was generally consistent across subgroups of patients with poor risk factors (patients who received prior treatment with blinatumomab or inotuzumab ozogamicin, patients who received prior allo-SCT, and primary refractory patients)5

Patients achieved 20.0 months (95% CI: 9.6, NE) mDOR without censoring for subsequent allo-SCT2

  • DOR was a secondary endpoint of the ZUMA-3 phase 2, single-arm, open-label study1,4
  • DOR data are descriptive and should be carefully interpreted in light of the single-arm study design
  • The study was not designed to assess efficacy of subsequent allo-SCT or to make comparisons between TECARTUS and allo-SCT as no head-to-head trial has been conducted
Median DOR in patients without censoring at allo-SCT at a median study follow-up of 20.0 months Median DOR in patients without censoring at allo-SCT at a median study follow-up of 20.0 months

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  • 74% of patients (n=26/35) did not receive allo-SCT following treatment with TECARTUS2
See Survival Data

ALL=acute lymphoblastic leukemia; allo-SCT=allogeneic stem cell transplant; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete hematologic recovery; DOR=duration of remission; KM=Kaplan-Meier; mDOR=median duration of remission; NE=not estimable; OCR=overall complete remission; R/R=relapsed or refractory.

References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. Data on file. Kite Pharma, Inc; 2022. 3.Shah BD, Ghobadi A, Oluwole OO, et al. Two-year follow-up of KTE-X19, an anti-CD19 chimeric antigen receptor T-cell therapy, in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia in ZUMA-3. Abstract 7010. Poster presented at the American Society of Clinical Oncology Annual Meeting; June 2-6, 2022; Chicago, IL. 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. Data on file. Kite Pharma, Inc; 2021.

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