Table 7.
Characterization of clinically approved CAR T-cell products.
| Full Generic Name | Axicabtagene Ciloleucel | Tisagenlecleucel | Lisocabtagene Maraleucel |
|---|---|---|---|
| Shortened name | Axi-cel | Tisa-cel | Liso-cel |
| Manufacturer | Kite-Gilead | Novartis | Bristol-Myers Squibb |
| Registration study | ZUMA-1 | JULIETT | TRANSCEND |
| Number of patients | |||
| Total | 111 | 165 | 344 |
| Infused | 101 (91% of total) | 111 (67% of total) | 269 (78% of total) |
| DLBCL de novo | 77 (76%) | 88 (79%) | 137 (51%) |
| DLBCL transformed | 16 (16%) | 21 (19%) | 78 (29%) |
| PMBL | 8 (8%) | 0 (0%) | 15 (6%) |
| Double/triple hit | NR | 19 (27%) * | 36 (13%) |
| Other | 0 (0%) | 2 (2%) ** | 3 (1%) # |
| Age | |||
| Median (range) | 58 (23–76) | 56 (22–76) | 63 (54–70) |
| ≥65 years | 24 (24%) | 25 (23%) | 112 (42%) |
| Gender | |||
| Male | 68 (67%) | NR | 174 (65%) |
| Female | 33 (33%) | NR | 95 (35%) |
| Disease status | |||
| Primary refractory | 2 (2%) | NR | NR |
| Relapse after ASCT | 21 (21%) | 54 (49%) | 94 (35%) |
| ≥3 lines of therapy | 70 (69%) | 57 (52%) | 139 (52%) |
| Bridging therapy administered | 0 | 92% | 159 (59%) |
| Response rate | |||
| ORR | 83% | 52% | 73% |
| CR | 58% | 40% | 53% |
| Survival | |||
| OS | 52% at 18 months | Median, 12 months | Median, 21.1 months |
| PFS | Median, 5.9 months | Median, 2.9 months | Median, 6.8 months |
| DOR | Median, 11.1 months | 65% at 12 months | 55% at 12 months |
| Adverse events | |||
| Cytokine release syndrome | |||
| All grades | 93% | 64 (58%) | 113 (42%) |
| Grade 3–4 | 13% | 24 (22%) | 6 (2%) |
| Neurotoxicity | |||
| All grades | 34% | 23 (21%) | 80 (30%) |
| Grade 3–4 | 21% | 13 (12%) | 27 (10%) |
| Infections | |||
| All grades | NR | 38 (34%) | not reported |
| Grade 3–4 | NR | 22 (20%) | not reported |
Abbreviations: ASCT = autologous stem cell transplantation; DOR = duration of response; DLBCL = diffuse large B-cell lymphoma; CR = complete remission; ORR = overall response rate; OS = overall survival; PFS = progression-free survival; PMBCL = primary mediastinal B-cell lymphoma; NR = not reported; * of 70 examined patients; ** Not specified; # Follicular lymphoma grade 3.