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Table 2 Supporting data for FDA approvals of axicabtagene ciloleucel and tisagenlecleucel for r/r DLBCL

From: Chimeric antigen receptor (CAR) T therapies for the treatment of hematologic malignancies: clinical perspective and significance

Drug

Axicabtagene ciloleucel

Tisagenlecleucel

Indication

r/r DLBCL (adult)

r/r DLBCL (adult)

Clinical Trial

ZUMA-1 (NCT02348216)

JULIET (NCT02445248)

Patients Treated (N)

101

68

Objective Response Rate (N, %)

73 (72%)

34 (50%)

95% CI

(62–81)

(37.6–62.4)

Complete Response Rate (N, %)

52 (51%)

22 (32%)

95% CI

(41–62)

(21.5–44.8)

Partial Response Rate (N, %)

21 (21%)

12 (18%)

95% CI

(13–30)

(9.5–28.8)

Median Duration of Response (mos)

9.2

NR

95% CI

(5.4 – NR)

(5.1 – NR)

Median Follow-up (mos)

7.9

9.4

Median Duration of Response for CR (mos)

NR

NR

95% CI

(8.1 – NR)

(10.0 – NR)

Median Duration of Response for PR (mos)

2.1

3.4

95% CI

(1.3–5.3)

(1.0 – NR)

  1. *Adapted from 9, 10, 13, 14. Abbreviations: CI Confidence interval, Mos Months, CR Complete response, PR Partial response