Supporting data for FDA approvals of axicabtagene ciloleucel and tisagenlecleucel for r/r DLBCL
| 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) |
*Adapted from 9, 10, 13, 14. Abbreviations: CI Confidence interval, Mos Months, CR Complete response, PR Partial response