Table 2.
Reports of CD19 CAR‐T cell therapy as second-line or first-line therapy for large B-cell lymphoma at the 2021 ASH annual meeting
Clinical trials (reference) | ZUMA-7 (axi-cel) [35] | TRANSFORM (liso-cel) [37] | BELINDA (Tisa-cel) [38] | ZUMA-12 (axi-cel) [39] |
---|---|---|---|---|
Study type |
Phase 3, randomized, global CAR-T VS SOC |
Phase 3, randomized, global CAR-T VS SOC |
Phase 3, randomized, global CAR-T VS SOC |
Phase 2, multicenter, single-arm |
Indication | Second-line | Second-line | Second-line | First-line |
Patients (n) | 359 | 184 | 322 | 40 |
Age (median, years) | 59 (21–81) | 59 (20–75) | 50% patients ≥ 65 years | 61 (23–86) |
Inclusion criteria | Aged ≥ 18 years with LBCL, ECOG PS 0–1, failure of first-line chemotherapy | Aged ≤ 75 years, eligible for ASCT, and with R/R LBCL within 12 months after first-line chemotherapy; ECOG PS ≤ 1 and adequate organ function | R/R NHL within 12 months after first-line chemotherapy | High-risk LBCL, defined by histology (double‑ or triple-hit status) or an IPI score ≥ 3, plus a positive interim PET after 2 cycles of chemotherapy |
Bridging therapy permitted | No | No | Yes | NA |
Response rate (ORR/CR) |
ORR: 83% vs 50% CR: 65% vs 32% |
ORR: 89% vs 48% CR: 66% vs 39% |
ORR: 46% vs 43% CR: 28% vs 28% |
ORR: 89% CR: 78% |
OS | Not reached vs 35.1 months | NA | NA | 12-month estimate: 91% |
PFS | 8.3 months vs 2 months | 14.8 months vs 5.7 months | 3 months vs 3 months |
Not reached 12-month estimate: 73% |
Grade ≥ 3 neutropenia | NA | 82% | NA | 68% |
Grade ≥ 3 thrombocytopenia | NA | 58% | NA | NA |
Grade ≥ 3 CRS | 6% | 1.1% | 5% | 8% |
Grade ≥ 3 ICANS | 21% | 0 | 3% | 23% |
Follow-up (months) | 24.9 | 6.2 | 10 | 15.9 |
NA not applicable