Efficacy and toxicity outcomes from pivotal phase 2 CAR-T trials compared against real world experience and phase 2 BiAb trials in R/R LBCL
. | Phase 2 CAR-T trials . | Real-world experience of CAR-T (axi-cel vs tisa-cel) . | Phase 2 expansion BiAb Trials . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ZUMA-1 (axi-cel)2 . | JULIET (tisa-cel)3 . | TRANSCEND NHL 001 (liso-cel)9 . | UK10 . | German GLA DRST registry11 . | Spanish12 . | French DESCAR-T13 ∗ . | US CAR-T consortium14 . | Epcoritamab6 . | Glofitamab7 . | Odronextamab8 . | |
| Median age (y) | 58 | 56 | 63 | 57 vs 63.5 | 60 vs 61 | 59 vs 62 | 62 vs 64 | 59 vs 67 | 68 | 66 | 67 |
| Median vein-to-vein time | 17 days | NR | 37 days | 40 days vs 50 days | 35 days vs 55 days | 41 days vs 52 days | NA | 28 days vs 45 days | Not applicable | ||
| ORR/CRR | 82%/58% | 52%/40% | 73%/53% | 44%/40% vs 32%/32% | 74%/42% vs 53%/ 32% | 60%/42% vs 54%/19% | 80%/60% vs 66%/42% | 52%/44% vs 41%/35% | 63%/39% | 52%/39% | 53%/37% |
| 12 mo OS/12 mo PFS | 59%/44% | 49%/ NR | 58%/44% | 57%/42% vs 44%/28% | 55%/35% vs 53%/24% | 51%/41% vs 47%/33% | 64%/47% vs 49%/33% | 62%/42% vs 59%/32% | NA (too short follow-up) | 50%/37% | NA (too short follow-up) |
| Any grade CRS/ ≥grade 3 | 93%/13% | 58%/22 | 42%/2% | 93%/8% vs 74%/8% | 81%/10% vs 65%/13% | 88%/8% vs 73%/6% | 86%/9% vs 76%/5% | 85%/9% vs 39%/1% | 50%/2.5% | 63%/4% | 53%/0% |
| Any grade ICANS/ ≥grade 3 | 64%/28% | 21%/12% | 30%/10% | 44%/20% vs 15%/4% | 44%/16% vs 22%/7% | 42%/18% vs 16%/5% | 49%/14% vs 22%/3% | 56%/38% vs 11%/1% | 6%/0.6% | 8%/3% | 4%/0% |
| NRM | 3% | 0% | NA | 9% vs 3% | 10% vs 4% | 7% vs 3% | NA | 12% vs 8% | 0.6% (ICANS related) | 0% | 2% |
. | Phase 2 CAR-T trials . | Real-world experience of CAR-T (axi-cel vs tisa-cel) . | Phase 2 expansion BiAb Trials . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ZUMA-1 (axi-cel)2 . | JULIET (tisa-cel)3 . | TRANSCEND NHL 001 (liso-cel)9 . | UK10 . | German GLA DRST registry11 . | Spanish12 . | French DESCAR-T13 ∗ . | US CAR-T consortium14 . | Epcoritamab6 . | Glofitamab7 . | Odronextamab8 . | |
| Median age (y) | 58 | 56 | 63 | 57 vs 63.5 | 60 vs 61 | 59 vs 62 | 62 vs 64 | 59 vs 67 | 68 | 66 | 67 |
| Median vein-to-vein time | 17 days | NR | 37 days | 40 days vs 50 days | 35 days vs 55 days | 41 days vs 52 days | NA | 28 days vs 45 days | Not applicable | ||
| ORR/CRR | 82%/58% | 52%/40% | 73%/53% | 44%/40% vs 32%/32% | 74%/42% vs 53%/ 32% | 60%/42% vs 54%/19% | 80%/60% vs 66%/42% | 52%/44% vs 41%/35% | 63%/39% | 52%/39% | 53%/37% |
| 12 mo OS/12 mo PFS | 59%/44% | 49%/ NR | 58%/44% | 57%/42% vs 44%/28% | 55%/35% vs 53%/24% | 51%/41% vs 47%/33% | 64%/47% vs 49%/33% | 62%/42% vs 59%/32% | NA (too short follow-up) | 50%/37% | NA (too short follow-up) |
| Any grade CRS/ ≥grade 3 | 93%/13% | 58%/22 | 42%/2% | 93%/8% vs 74%/8% | 81%/10% vs 65%/13% | 88%/8% vs 73%/6% | 86%/9% vs 76%/5% | 85%/9% vs 39%/1% | 50%/2.5% | 63%/4% | 53%/0% |
| Any grade ICANS/ ≥grade 3 | 64%/28% | 21%/12% | 30%/10% | 44%/20% vs 15%/4% | 44%/16% vs 22%/7% | 42%/18% vs 16%/5% | 49%/14% vs 22%/3% | 56%/38% vs 11%/1% | 6%/0.6% | 8%/3% | 4%/0% |
| NRM | 3% | 0% | NA | 9% vs 3% | 10% vs 4% | 7% vs 3% | NA | 12% vs 8% | 0.6% (ICANS related) | 0% | 2% |
LBCL, large B cell lymphoma; NA, not available; NR, not reported; NRM, nonrelapse mortality; PFS, progression free survival.
The French DESCAR-T study used propensity score matching between axi-cel and tisa-cel, which might affect comparison of headline figures.