Table 1.
Summary of results from randomized trials comparing CD19-CAR T versus autologous stem cell transplant in patients with DLBCL who were refractory to R-CHOP or experienced disease progression within one year after the end of R-CHOP.
| Study name and reference | ZUMA-7 (19) | TRANSFORM (21) | BELINDA (20) |
|---|---|---|---|
| CD19-CAR T-cell in experimental arm | Axi-cel | Liso-cel | Tisa-cel |
| Number of patients | 359 | 184 | 322 |
| Patients proceeding to CAR T vs. ASCT (%) | 94% / 36% | 97% / 47% | 96% / 32% |
| Median time from registration to CAR T infusion | 29 days | 34 days | 52 days |
| Bridging therapy allowed (% receiving bridging therapy) | Steroids only | One cycle of salvage chemotherapy (63%) | One cycle or more of salvage chemotherapy (97%, including 54% >1 regimen) |
| Crossover to CAR (% who proceeded) | Not planned (56% received cellular immunotherapy) | Planned per protocol (63%) | Planned per protocol (51%) |
| Median follow-up | 25 months | 17.5 months | 10 months |
| Complete response rate (%) | 65% vs 32% | 74% vs 43% | 28% vs 28% |
| Median event-free survival (months) | 8.3 vs. 2 | Not reached vs. 2.4 | 3 vs 3 |
| Median progression-free survival (months) | 14.7 vs. 3.7 | Not reached vs. 6.2 | na |
| Median overall survival (months) | Not reached vs. 35.1 (0.73) | Not reached vs. 29.9 (0.72) | 16.9 vs. 15.3 |
| Any grade CRS/NE (%) | 92%/60% | 49%/11% | 61%/10% |
| Grade >=3 CRS/NE (%) | 6%/21% | 1%/4% | 5%/2% |
ASCT, high-dose therapy and autologous stem cell support; CAR T, chimeric antigen receptor T-cell therapy; RCHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone; CRS, cytokine release syndrome; NE, neurologic event.