Table 2.
Key Phase 1/2 and Real-World Clinical Variables for axi-cel and tisa-cel
| tisa-cel | axi-cel | |
|---|---|---|
| Pivotal trial | JULIET | ZUMA1 |
| Bridging | 90% | not allowed |
| LDC | 74% flu-cy (25 mg/m2, 250 mg/m2 ×3 days, 19% benda, 7% none | 100% flu-cy (30 mg/m2, 500 mg/m2 |
| Prior ASCT | 49% | 25% |
| <3 lines of prior therapy | 49% | 31% |
| Relapsed <12 months post ASCT | 34% | 21% |
| Double/triple hit | 17% | 4% |
| Bulky disease | 8% | 16% |
| HSCT post infusion | 6% | 11% |
| Retreatment | 0% | 9% |
| Never treated | 31% | 9% |
| ORR | 54% | 83% |
| 6-month CR | 29% | 37% |
| Real world data reference | 17 | 18 |
| Number of patients (outcomes available) | 47 | 295 |
| ASTCT CRS 3+ | 4.30% | 14% |
| ASTCT ICANS 3+ | 4.30% | 39% |
| ICU stay | not reported | 30% |
| Deaths due to toxicity | 0 | 5 |
| ORR | 61%, 57%a | 70% |
| CR | 39%, 38%a | 52% |
flu, fludarabine; cy, cyclophosphamide.
a
CIBMTR registry data for tisa-cel was stratified by cellular viability either >80% or 60%–80%, and ORR and CR are reported respectively.