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

Objective response rate graph Objective response rate graph

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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
Duration of Response graph Duration of Response graph

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  • 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.