In adult patients with R/R B-cell precursor ALL
TECARTUS® provided deep and durable responses in ZUMA-31,2
Primary analysis: 65% overall complete remission rate (CR + CRi) and 52% CR rate with TECARTUS at a median study follow-up of 12.3 months1,3
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- TECARTUS provided high OCR rates, including patients who were R/R following prior treatment with blinatumomab (OCR rate=56%; n=14/25) or inotuzumab ozogamicin (OCR rate=67%; n=8/12), patients who previously relapsed following allo-SCT (OCR rate=70%; n=16/23), and patients who had primary refractory disease (OCR rate=72%; n=13/18)2
Leukapheresis to CR in <3 months2
- Median time from leukapheresis to CR: 2.7 months (range: 1.77, 4.04 months)
97% of patients who achieved CR/CRi (n=34/35) were MRD-negative2
- MRD-negativity rate (10−4 sensitivity) was a secondary endpoint of the ZUMA-3 trial.4 The MRD assay used in this trial has not been analytically validated in accordance with the FDA guidance “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry” issued in 2020. These data are not included in the TECARTUS USPI and should be carefully interpreted as further validation of the assay is needed5
Consistent response rates observed across efficacy analyses
Response rates in
ZUMA-3*
Efficacy-evaluable population (n=54)
Primary analysis
(data cutoff September 9, 2020)1,6
Response rate (n) [95% Cl]
Overall complete remission rate (CR + CRi)
65% (35) [51, 77]
Complete remission rate
52% (28) [38, 66]
~4-year analysis†
(data cutoff July 23, 2023)7
Response rate (n) [95% Cl]
Overall complete remission rate (CR + CRi)
73% (40) [59, 84]
Complete remission rate
60% (33) [46, 73]
All leukapheresed patients (n=71)
Primary analysis
(data cutoff September 9, 2020)1,6
Response rate (n) [95% Cl]
Overall complete remission rate (CR + CRi)
51% (36) [39, 63]
Complete remission rate
41% (29) [29, 53]
~4-year analysis†
(data cutoff July 23, 2023)7
Response rate (n) [95% Cl]
Overall complete remission rate (CR + CRi)
56% (40) [44, 68]
Complete remission rate
47% (33) [35, 59]
Efficacy-evaluable population (n=54)
Response rate (n) [95% Cl]
Primary analysis
(data cutoff September 9, 2020)1,6
~4-year analysis†
(data cutoff July 23, 2023)7
Overall complete remission rate (CR + CRi)
Complete remission rate
65% (35) [51, 77]
52% (28) [38, 66]
73% (40) [59, 84]
60% (33) [46, 73]
All leukapheresed patients (n=71)
Response rate (n) [95% Cl]
Primary analysis
(data cutoff September 9, 2020)1,6
~4-year analysis†
(data cutoff July 23, 2023)7
Overall complete remission rate (CR + CRi)
Complete remission rate
51% (36) [39, 63]
41% (29) [29, 53]
56% (40) [44, 68]
47% (33) [35, 59]
*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
†Potential follow-up time.
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; FDA=Food and Drug Administration; MRD=minimal residual disease; OCR=overall complete remission; R/R=relapsed or refractory; USPI=US Prescribing Information.
References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2024. 2. Data on file [1]. Kite Pharma, Inc; 2023. 3. Data on file. Kite Pharma, Inc; 2021. 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. Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry. Oncology Center of Excellence in cooperation with the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, Food and Drug Administration, US Dept of Health and Human Services; January 2020. 6. Data on file. Kite Pharma, Inc; 2022. 7. Data on file [2]. Kite Pharma, Inc; 2023.
~4-year analysis (median follow-up: 50.7 months)*: TECARTUS provided a median DOR of 13.7 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 4-year analysis are not included in the USPI
- ~4-year follow-up analysis was conducted in the 54 efficacy-evaluable patients treated with TECARTUS in the ZUMA-3 study2
*Potential follow-up time.2
†In this analysis, patients were censored for the following reasons: allo-SCT, ongoing remission, started a new anti-cancer therapy, lost to follow-up, and withdrawal of consent.3
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Primary analysis1
- In the primary analysis (median study follow-up: 12.3 months), mDOR 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)
- 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)
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; mDOR=median duration of remission; NE=not estimable; OCR=overall complete remission; R/R=relapsed or refractory; USPI=US Prescribing Information.
References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2024. 2. Data on file. Kite Pharma, Inc; 2024. 3. Data on file. Kite Pharma, Inc; 2023. 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.