In patients with relapsed or refractory (R/R) mantle cell lymphoma
Deep, durable, and rapid responses were demonstrated in ZUMA-21
Primary analysis1
Objective response rate
Nearly all patients achieved a response (n=52/60) and 62% of patients achieved CR with TECARTUS at a median study follow-up of 12.3 months1,2
Pinch to zoom
Responses were rapid—the median time to initial response was 1 month (range: 0.8-3.1 months)1
- Median time to complete response was 3 months (range: 1.0-9.3 months)3
Patients experienced deep responses—62% of patients achieved a CR with TECARTUS1
24-month analysis
Consistent response rates demonstrated across efficacy analyses
Response rates in ZUMA-2
Efficacy-evaluable population (n=60)
Primary analysis
(data cutoff July 24, 2019)1,4
Response rate (n) [95% Cl]
Objective response rate*
87% (52) [75, 94]
Complete remission rate
62% (37) [48, 74]
Partial remission rate
25% (15) [15, 38]
24-month analysis
(data cutoff July 24, 2021)4,5
Response rate (n) [95% Cl]
Objective response rate*
87% (52) [75, 94]
Complete remission rate
63% (38) [50, 75]
Partial remission rate
23% (14) [13, 36]
All leukapheresed patients (n=74)
Primary analysis
(data cutoff July 24, 2019)1,4
Response rate (n) [95% Cl]
Objective response rate*
80% (59) [69, 88]
Complete remission rate
55% (41) [43, 67]
Partial remission rate
24% (18) [15, 36]
24-month analysis
(data cutoff July 24, 2021)4,6
Response rate (n) [95% Cl]
Objective response rate*
80% (59) [69, 88]
Complete remission rate
57% (42) [45, 68]
Partial remission rate
23% (17) [14, 34]
Efficacy-evaluable population (n=60)
Response rate (n) [95% Cl]
Primary analysis
(data cutoff July 24, 2019)1,4
24-month analysis
(data cutoff July 24, 2021)4,5
Objective response rate*
Complete remission rate
Partial remission rate
87% (52) [75, 94]
62% (37) [48, 74]
25% (15) [15, 38]
87% (52) [75, 94]
63% (38) [50, 75]
23% (14) [13, 36]
All leukapheresed patients (n=74)
Response rate (n) [95% Cl]
Primary analysis
(data cutoff July 24, 2019)1,4
24-month analysis
(data cutoff July 24, 2021)4,6
Objective response rate*
Complete remission rate
Partial remission rate
80% (59) [69, 88]
55% (41) [43, 67]
24% (18) [15, 36]
80% (59) [69, 88]
57% (42) [45, 68]
23% (17) [14, 34]
The ZUMA-2 24-month analysis has the longest study follow-up of any study of CAR T-cell therapy in R/R MCL7,8
- Median potential follow-up time was nearly 3 years (35.6 months)4
- Minimum follow-up in this analysis was 25.9 months; maximum was 56.3 months4
*Among all responders. DOR is measured from the date of first objective response to the date of progression or death.1
CAR=chimeric antigen receptor; CI=confidence interval; CR=complete response; DOR=duration of response; MCL=mantle cell lymphoma; ORR=objective response rate; PR=partial response; R/R=relapsed or refractory.
References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. Data on file [1]. Kite Pharma, Inc; 2020. 3. Data on file [2]. Kite Pharma, Inc; 2020. 4. Data on file [1]. Kite Pharma, Inc; 2022. 5. Data on file [2]. Kite Pharma, Inc; 2022. 6. Data on file [3]. Kite Pharma, Inc; 2022. 7. U.S. National Library of Medicine. Study evaluating the safety and pharmacokinetics of JCAR017 in B-cell non-Hodgkin lymphoma (TRANSCEND-NHL-001). ClinicalTrials.gov identifier: NCT02631044. Updated June 21, 2021. Accessed March 23, 2022. https://clinicaltrials.gov/ct2/show/NCT02631044 8. U.S. National Library of Medicine. Study to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in participants with relapsed/refractory mantle cell lymphoma (ZUMA-2). ClinicalTrials.gov identifier: NCT02601313. Updated August 31, 2021. Accessed March 23, 2022. https://clinicaltrials.gov/ct2/show/NCT02601313
Duration of response
With TECARTUS, median duration of response was 36.5 months at a median potential follow-up of nearly 3 years (35.6 months)2,3
- DOR was a secondary endpoint of the ZUMA-2 phase 2, single-arm, open-label study
- DOR data below are descriptive and should be carefully interpreted in light of the single-arm design. DOR data from the 24-month analysis are not included in the USPI
- 24-month follow-up analysis was conducted after all 68 patients treated with TECARTUS in the ZUMA-2 study had the opportunity to be followed for at least 24 months or until death or withdrawal from the study. The Kaplan-Meier estimate for the updated analysis mDOR was for the median potential follow-up of 35.6 months for patients with an objective response (n=52)1,2,4,5
Pinch to zoom
- Primary analysis: 62% of all patients (n=32/52) who responded and 81% of patients (n=30/37) with a CR remained in remission at the time of primary data cutoff (July 24, 2019)2,6
- mDOR was not reached at a median study follow-up of 12.3 months
44% of patients (n=23/52) remained in remission after at least 24 months of follow-up3
Duration of response was consistent across efficacy analyses
Duration of response
in ZUMA-2
Median DOR in efficacy-evaluable
population (n=52)1,3
Primary analysis
(data cutoff July 24, 2019)1,2
mDOR in months [95% Cl]
- NR [8.6, NE]
Range* in months
- 0.0+, 29.2+
mDOR, if best response is CR,
in months [95% Cl]
- NR [13.6, NE]
Range* in months
- 1.9+, 29.2+
mDOR, if best response is PR,
in months [95% Cl]
- 2.2 [1.5, 5.1]
Range* in months
- 0.0+, 22.1+
24-month analysis
(data cutoff July 24, 2021)2,3
mDOR in months [95% Cl]
- 36.5 [14.4, 47.1]
Range* in months
- 0.0+, 53.0+
mDOR, if best response is CR,
in months [95% Cl]
- 47.1 [24.8, NE]
Range* in months
- 1.9+, 53.0+
mDOR, if best response is PR,
in months [95% Cl]
- 2.2 [1.5, 5.1]
Range* in months
- 0.0+, 45.6
Median DOR in all
leukapheresed patients (n-59)1,7
Primary analysis
(data cutoff July 24, 2019)1,2
mDOR in months [95% Cl]
- NR [8.6, NE]
Range* in months
- 0.0+, 29.2+
mDOR, if best response is CR,
in months [95% Cl]
- NR [13.6, NE]
Range* in months
- 0.0+, 29.2+
mDOR, if best response is PR,
in months [95% Cl]
- 2.2 [1.5, 5.1]
Range* in months
- 0.0+, 22.1+
24-month analysis
(data cutoff July 24, 2021)2,7
mDOR in months [95% Cl]
- 28.2 [13.5, 46.7]
Range* in months
- 0.0+, 53.0+
mDOR, if best response is CR,
in months [95% Cl]
- 46.7 [24.8, NE]
Range* in months
- 1.6+, 53.0+
mDOR, if best response is PR,
in months [95% Cl]
- 3.2 [1.5, 5.1]
Range* in months
- 0.0+, 45.6
Median DOR in efficacy-evaluable population (n=52)1,3
Primary analysis
(data cutoff July 24, 2019)1,2
24-month analysis
(data cutoff July 24, 2021)2,3
mDOR in months [95% CI]
Range* in months
mDOR, if best response is CR,
in months [95% Cl]
Range* in months
mDOR, if best response is PR,
in months [95% Cl]
Range* in months
NR [8.6, NE]
0.0+, 29.2+
NR [13.6, NE]
1.9+, 29.2+
2.2 [1.5, 5.1]
0.0+, 22.1+
36.5 [14.4, 47.1]
0.0+, 53.0+
47.1 [24.8, NE]
1.9+, 53.0+
2.2 [1.5, 5.1]
0.0+, 45.6
Median DOR in all leukapheresed patients (n=59)1,7
Primary analysis
(data cutoff July 24, 2019)1,2
24-month analysis
(data cutoff July 24, 2021)2,7
mDOR in months [95% CI]
Range* in months
mDOR, if best response is CR,
in months [95% Cl]
Range* in months
mDOR, if best response is PR,
in months [95% Cl]
Range* in months
NR [8.6, NE]
0.0+, 29.2+
NR [13.6, NE]
0.0+, 29.2+
2.2 [1.5, 5.1]
0.0+, 22.1+
28.2 [13.5, 46.7]
0.0+, 53.0+
46.7 [24.8, NE]
1.6+, 53.0+
3.2 [1.5, 5.1]
0.0+, 45.6+
- DOR data are descriptive and should be carefully interpreted in light of the single-arm design†
*A + sign indicates a censored value.1
†24-month analysis data are not included in the USPI.
CI=confidence interval; CR=complete response; DOR=duration of response; mDOR=median duration of response; NE=not estimable; NR=not reached; OR=objective response; ORR=objective response rate; PR=partial response; USPI=US Prescribing Information.
References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. Data on file [1]. Kite Pharma, Inc; 2022. 3. Data on file [2]. Kite Pharma, Inc; 2022. 4. Data on file [1]. Kite Pharma, Inc; 2020. 5. Data on file [3]. Kite Pharma, Inc; 2022. 6. Data on file [2]. Kite Pharma, Inc; 2020.
7. Data on file [4]. Kite Pharma, Inc; 2022.