Prescribing Information

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In adult patients with relapsed or refractory (R/R) mantle cell lymphoma

TECARTUS® provided deep and durable responses1

Pivotal analysis: In ZUMA-2 (Study 1, Cohort 1: BTKi-exposed), nearly all patients achieved a response (n=52/60) with TECARTUS at a median study follow-up of 8.6 months1,2

Objective response rate graph. Objective response rate graph.

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Infusion to response in 1 month1*

  • Median: 28 days (range: 24-92)

ZUMA-2† (Cohort 3: BTKi-naïve)1

  • Nearly all patients achieved response (n=78/86) with TECARTUS at a median study follow-up of 15.5 months
Circle graph showing a 91% ORR, 68% CR, and 24% PR Circle graph showing a 91% ORR, 68% CR, and 24% PR

Median time to response: 1 month (range: 0.8-1.9)1

5-year follow-up: Consistent response rate was observed in ZUMA-2,† Cohort 13

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Study limitations

These results represent a separate, preplanned, post hoc analysis of the ZUMA-2† study. Data from the ~5-year analysis are descriptive and the study was not powered or adjusted for multiplicity to assess efficacy in this follow-up study. These data are not included in the Prescribing Information for TECARTUS and should be carefully interpreted.

*Median: 28 days (range: 24-92).1

†The ZUMA-2 trial corresponds to Study 1 in the US Prescribing Information; see Section 14.1 on page 22.

BTKi=Bruton tyrosine kinase inhibitor; CI=confidence interval; CR=complete response; DOR=duration of response; ORR=objective response rate; PR=partial response.

References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing Information. Kite Pharma, Inc; 2026. 2. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle cell lymphoma. N Engl J Med. 2020;382(14):1331-1342. 3. Muñoz J, Locke FL, Reagan PM, et al. Five-year follow-up of patients with relapsed/refractory mantle cell lymphoma treated with anti-CD19 CAR T-cell therapy in ZUMA-2, Cohorts 1 and 2. J Hematol Oncol. 2026;19(1):39. doi:10.1186/s13045-026-01797-4 4. 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.

TECARTUS provided 36.5 months mDOR (95% CI, 17.7-48.9) in the 5-year analysis per investigator review. Median follow-up of 67.8 months (range: 58.2-88.6) per investigator review2*†

Graphic showing median duration of response was reached at 28.2 months at ~3 year follow-up Graphic showing median duration of response was reached at 28.2 months at ~3 year follow-up

The tick marks represent censored patients. Subjects not meeting the criteria (ie, patients who experienced disease progression or death) by the analysis data cutoff date were censored at their last evaluable disease assessment date and their response was noted as ongoing, except for those censored due to being lost to follow-up, withdrawal of consent, or initiating subsequent therapy (including SCT).

Reprinted from Wang M, Muñoz 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. doi:10.1200/JCO.21.02370

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  • DOR was a secondary endpoint of the ZUMA-2 (Study 1) phase 2, single-arm, open-label study3
  • DOR data from the ~5-year analysis are not included in the USPI. DOR data are descriptive and should be carefully interpreted
  • ~5-year median study follow-up analysis was conducted in all 60 patients treated with TECARTUS in the ZUMA-2‡ study2
  • In the primary analysis, mDOR was not reached (95% CI: 8.6-NE) at a median study follow-up of 12.3 months; number of responders=52/601,3

Study limitations

These results represent a separate, preplanned, post hoc analysis of the ZUMA-2‡ study. Data from the ~5-year analysis are descriptive and the study was not powered or adjusted for multiplicity to assess efficacy in this follow-up study. These data are not included in the Prescribing Information for TECARTUS and should be carefully interpreted.

*Kaplan-Meier estimate based on the 60 patients with a response.2

†DOR was measured from the start of first objective response to the date of progression or death.1

‡The ZUMA-2 trial corresponds to Study 1 in the US Prescribing Information; see Section 14.1 on page 22.

CI=confidence interval; DOR=duration of response; mDOR=median duration of response; NE=not estimable; ORR=objective response rate; SCT=stem cell transplant; USPI=United States Prescribing Information.

References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing Information. Kite Pharma, Inc; 2026. 2. Muñoz J, Locke FL, Reagan PM, et al. Five-year follow-up of patients with relapsed/refractory mantle cell lymphoma treated with anti-CD19 CAR T-cell therapy in ZUMA-2, Cohorts 1 and 2. J Hematol Oncol. 2026;19(1):39. doi:10.1186/s13045-026-01797-4 3. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle cell lymphoma. N Engl J Med. 2020;382(14):1331-1342.

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