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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