Table 1 -.
Comparisons Across Trials
| ZUMA-1 (axicabtagene ciloleucel) |
JULIET (tisagenlecleucel) |
ZUMA-7 (axicabtagene ciloleucel arm) |
BELINDA (tisagenlecleucel arm) |
ZUMA-7 (SOC arm) |
BELINDA (SOC arm) |
|
|---|---|---|---|---|---|---|
| Primary Endpoint | Overall response rate | Overall response rate | Event Free Survival | Event Free Survival after week 12 | Event Free Survival | Event Free Survival after week 12 |
| Patient Characteristics | ||||||
| - No. of Patients | N=111 (total cohort), N=101 (infused cohort) | N=165 (total cohort), N=111 (infused cohort) | N=180 | N=162 | N=179 | N=160 |
| - Median Age (range), years | 58 (23–76) | 56 (22–76) | 58 (21–80) | 60 (19–79) | 60 (26–81) | 58 (19–77) |
| - Age ≥65 years | 24 (24%) | 25 (23%) | 51 (28%) | 54 (33%) | 58 (32%) | 46 (29%) |
| Study eligibility | ||||||
| - Disease status | Refractory or <12m relapse after ASCT | Relapsed or refractory after 2 lines | Refractory or <12m relapse, ASCT-eligible | Refractory or <12m relapse, ASCT-eligible | Refractory or <12m relapse, ASCT-eligible | Refractory or <12m relapse, ASCT-eligible |
| no impending organ compromise | no impending organ compromise | no impending organ compromise | ||||
| - Bridging therapy | Steroids only | Chemotherapy optional (92% received) |
Steroids only (36% received) |
Chemotherapy optional (83% received) |
n/a | n/a |
| CD19 positive | 74 of 82 (90%) | 49 of 72 (68%) | 144 (80%) | not reported | 134 (75%) | not reported |
| Histology | ||||||
| - DLBCL: NOS | 77 (76%) | 88 (79%) | 126 (70) | 101 (62%) | 120 (67%) | 112 (70%) |
| - HGBL-DH | not reported | 19 of 70 (27%) | 31 (17) | 32 (20%) | 25 (14%) | 19 (12%) |
| - HGBL-NOS | 0 | 0 | 0 (0%) | 7 (4%) | 1 (1%) | 8 (5%) |
| - FL grade 3B | 0 | 0 | 0 (0%) | 5 (3%) | 0 (0%) | 1 (0.6%) |
| - PMBL | 8 (8%) | 0 | 0 (0%) | 12 (7%) | 0 (0%) | 13 (8%) |
| - Other/missing | 0 | 2 (2%) | 23 (13%) | 5 (3%) | 33 (18%) | 7 (4%) |
| Transformed lymphoma | 16 (16%) | 21 (19%) | 19 (11%) | 27 (17%) | 27 (15%) | 22 (14%) |
| Cell Of Origin | ||||||
| - GCB-like | 49 (74%) | 63 (57%) | 109 (61%) | 46 (28%) | 99 (55%) | 63 (39%) |
| - ABC-like | 17 (26%) | 45 (41%) | 16 (9%) | 52 (32%) | 9 (5%) | 42 (26%) |
| - Unclassified | 0 | 0 | 17 (9%) | 3 (2%) | 14 (8%) | 7 (4%) |
| - Missing/not applicable | 35 (35%) | 3 (3%) | 38 (21%) | 0 (0%) | 57 (32%) | 0 (0%) |
| Disease status at study entry | ||||||
| - Refractory to any therapy | 80 (79%) | 61 (55%) | 133 (74%) | 107 (66%) | 131 (73%) | 107 (67%) |
| - Relapsed | 21 (21%) | 50 (45%) | 47 (26%) | 55 (34%) | 48 (26%) | 53 (33%) |
| - Prior ASCT | 21 (21%) | 54 (49%) | n/a | n/a | n/a | n/a |
| On Study Characteristics | ||||||
| - Progressive disease prior to CAR-T | 1 (1%) | ~23% | 2 (1%) | 42 (26%) | n/a | n/a |
| - Crossover to CAR-T allowed on study | n/a | n/a | n/a | n/a | No (56% received off protocol) | Yes (51% crossed over) |
| - Received ASCT on study | n/a | n/a | n/a | n/a | 64 (36%) | 52 (33%) |
| - Received CAR-T infusion | 101 (91%) | 111 (67%) | 170 (94%) | 155 (96%) | n/a | n/a |
| - Enrollment to CAR-T infusion | ~17 days | 54 days | 29 days | 52 days | n/a | n/a |
| - Leukapheresis to CAR-T release | not reported | not reported | 13 days | 23.5 days (U.S.), 28 days (non-U.S.) | n/a | n/a |
| - CAR-T cell dose | 2×106 CAR-T cells/kg | 3 × 108 CAR-T cells | 2×106 CAR-T cells/kg | 2.9 × 108 CAR-T cells | n/a | n/a |
| Clinical Outcomes | ||||||
| - Overall Response Rate | 82% | 52% (efficacy cohort) 34% (ITT cohort) |
83% | 46% | 50% | 42% |
| - Complete Response Rate | 54% | 40% (efficacy cohort) | 65% | 28% | 32% | 28% |
| - Median follow-up | 27.1m | 40.3m | 25m | 10m | 25m | 10m |
| - 2-year PFS | ~40% | ~35% | ~46% | not reported | 27% (estimate) | not reported |
| - 2-year PFS in CR | 72% | ~80% | not reported | not reported | not reported | not reported |
| - 2-year OS | 51% | ~45% | 61% | not reported | 52% | not reported |