Table 3.
Comparison of clinical factors before and after MAIC of OS in TRANSCEND and JULIET
| Clinical factor | JULIET (tisagenlecleucel) safety set/full analysis set [8] | TRANSCEND (liso-cel) DLBCL efficacy set [6] |
|||||
|---|---|---|---|---|---|---|---|
| Before MAIC (naive) | After MAIC (primary) | After MAIC (sensitivity) | |||||
| ESS, N | 111 | 256 | 180 | 24.8 | |||
| Unadjusted | SMD | Adjusted | SMD | Adjusted | SMD | ||
|---|---|---|---|---|---|---|---|
| Mean (SD) age, years | 53.9 (12.9) | 60.3 (13.3) | 0.483 | 61.3 (11.8) | 0.605 | 53.9 (13.1) | 0.000 |
| Male sex, % | 61.3 | 66.0 | 0.098 | 66.5 | 0.108 | 61.3 | 0.000 |
| IPI score, categorized per JULIET categorization, % | |||||||
| 0‒1 | 27.9 | 24.6 | 0.070 | 28.7 | 0.020 | 27.9 | 0.000 |
| 2‒5 | 72.1 | 74.6 | – | 70.9 | – | 72.1 | – |
| Missing | 0 | 0.8 | – | 0.3 | – | 0 | – |
| ECOG PS score at screening, % | |||||||
| 0 | 55.0 | 40.6 | 0.331 | 55.0 | 0.000 | 55.0 | 0.000 |
| 1 | 45.0 | 57.8 | – | 45.0 | – | 45.0 | – |
| 2 | 0 | 1.6 | – | 0 | – | 0 | – |
| Disease stage, % | |||||||
| I or II | 24.3 | 27.0 | 0.066 | 30.5 | 0.141 | 24.3 | 0.000 |
| III or IV | 75.7 | 72.3 | – | 69.2 | – | 75.7 | – |
| Missing | 0 | 0.8 | – | 0.3 | – | 0 | – |
| Secondary CNS lymphoma at time of treatment, % | |||||||
| No | 100 | 97.7 | 0.219 | 100 | 0.000 | 100 | 0.000 |
| Yes | 0 | 2.3 | – | 0 | – | 0 | – |
| Disease histology, categorized per JULIET categorization, % | |||||||
| DLBCL | 81.1 | 71.1 | 0.397 | 81.1 | 0.000 | 81.1 | 0.000 |
| DLBCL tFL | 18.9 | 22.3 | – | 18.9 | – | 18.9 | – |
| PMBCL | 0 | 5.5 | – | 0 | – | 0 | – |
| FL3B | 0 | 1.2 | – | 0 | – | 0 | – |
| Cell of origin, % | |||||||
| GCB | 56.8 | 44.1 | 0.630 | 45.2 | 0.604 | 56.8 | 0.000 |
| ABC | 40.5 | 28.1 | – | 33.2 | – | 40.5 | – |
| Unknown | 2.7 | 21.1 | – | 21.6 | – | 2.7 | – |
| Missing | 0 | 6.6 | – | 0 | – | 0.0 | – |
| Double or triple hit, % | |||||||
| Unknown | 36.9 | 29.3 | 0.202 | 28.6 | 0.219 | 37.0 | 0.000 |
| No | 45.9 | 55.9 | – | 56.6 | – | 45.9 | – |
| Yes | 17.1 | 14.8 | – | 14.8 | – | 17.1 | – |
| Prior allo-HSCT, % | |||||||
| No | 100 | 97.3 | 0.237 | 100 | 0.000 | 100 | 0.000 |
| Yes | 0 | 2.7 | – | 0 | – | 0 | – |
| Prior auto-HSCT, % | |||||||
| No | 51.4 | 66.8 | 0.317 | 51.4 | 0.000 | 51.4 | 0.000 |
| Yes | 48.6 | 33.2 | – | 48.6 | – | 48.6 | – |
| Bridging therapy, % | |||||||
| No | 8.1 | 41.4 | 0.837 | 47.4 | 0.977 | 52.4 | 1.101 |
| Yes | 91.9 | 58.6 | – | 52.6 | – | 47.6 | – |
| Number of prior lines of therapy, per JULIET definition, % | |||||||
| 1 | 4.5 | 0.4 | 0.859 | 0.6 | 0.894 | 0 | 0.315 |
| 2 | 44.1 | 19.5 | – | 16.9 | – | 48.7 | – |
| 3 | 30.6 | 26.6 | – | 28.0 | – | 30.6 | – |
| 4‒6 | 20.7 | 43.4 | – | 46.1 | – | 20.7 | – |
| ≥ 7 | 0 | 9.8 | – | 8.4 | – | 0 | – |
| Missing | 0 | 0.4 | – | 0 | – | 0 | – |
| R/R to last therapy, per JULIET definition, % | |||||||
| Refractory | 55.0 | 63.7 | 0.182 | 55.0 | 0.000 | 55.0 | 0.000 |
| Relapsed | 45.0 | 35.9 | – | 45.0 | – | 45.0 | – |
| Missing | 0 | 0.4 | – | 0 | – | 0 | – |
| CrCl pre-lymphodepletion, per JULIET criteria, % | |||||||
| < 60 mL/min | 0 | 19.1 | 0.688 | 22.3 | 0.757 | 0 | 0.000 |
| ≥ 60 mL/min | 100 | 80.9 | – | 77.7 | – | 100.0 | – |
| LVEF at screening, per JULIET criteria, % | |||||||
| < 45% | 0 | 1.6 | 0.178 | 1.4 | 0.170 | 0 | 0.000 |
| ≥ 45% | 100 | 98.4 | – | 98.6 | – | 100.0 | – |
| ALC pre-leukapheresis, per JULIET criteria, % | |||||||
| < 0.3 | 0 | 10.5 | 0.501 | 10.1 | 0.491 | 0 | 0.000 |
| ≥ 0.3 | 100 | 84.0 | – | 83.6 | – | 100.0 | – |
| Missing | 0 | 5.5 | – | 6.3 | – | 0 | – |
| Statistics, % | |||||||
| Factors with SMD < 0.2, | – | 29.4 | – | 58.8 | – | 88.2 | – |
| Factors with SMD < 0.1, | – | 17.6 | – | 41.2 | – | 88.2 | – |
ABC activated B cell, ALC absolute lymphocyte count, allo-HSCT allogeneic hematopoietic stem cell transplantation, auto-HSCT autologous hematopoietic stem cell transplantation, CNS central nervous system, CrCl creatinine clearance, DLBCL diffuse large B-cell lymphoma, ECOG PS Eastern Cooperative Oncology Group performance status, ESS effective sample size, FL3B follicular lymphoma grade 3B, GCB germinal center B cell, HSCT hematopoietic stem cell transplantation, IPI International Prognostic Index, liso-cel lisocabtagene maraleucel, LVEF left ventricular ejection fraction, MAIC matching-adjusted indirect comparison, OS overall survival, PMBCL primary mediastinal B-cell lymphoma, R/R relapsed or refractory, SD standard deviation, SMD standardized mean difference, tFL transformed follicular lymphoma