Table 1.
Patient characteristics at the time of axi-cel infusion and clinical outcomes (n = 57)
| Characteristic | N = 57 (%) |
|---|---|
| Age (y) | |
| Median, range | 59, 19-76 |
| Sex | |
| Male | 34 (60) |
| ECOG (0-5) | |
| 0-1 | 54 (95) |
| 2 | 3 (5) |
| Histology | |
| DLBCL, NOS | 32 (56) |
| Unknown MYC and BCL2/BCL6 status | 4 (7) |
| High grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements | 10 (18) |
| B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma | 11 (19) |
| Unknown MYC and BCL2/BCL6 status | 3 (5) |
| Primary mediastinal B-cell lymphoma | 4 (7) |
| Stage (I-IV) | |
| I/II | 15 (26) |
| III/IV | 42 (74) |
| LDH level before conditioning > ULN | |
| Yes | 37 (65) |
| CRP level before conditioning > ULN | |
| Yes | 25 (44) |
| Ferritin level before conditioning > ULN | |
| Yes | 31 (54) |
| IPI score (1-5) | |
| 0 | 4 (7) |
| 1-2 | 23 (40) |
| 3-5 | 25 (44) |
| N/A or primary mediastinal B-cell lymphoma | 5 (9) |
| Prior lines of therapy | |
| Median, range | 3, 1-7 |
| Bridging therapy | |
| Yes | 33 (58) |
| Chemotherapy/targeted therapy | 15 (26) |
| Steroids | 3 (5) |
| Radiation therapy | 7 (12) |
| Combination chemotherapy/targeted therapy ± steroids ± radiation therapy | 8 (14) |
| Received before baseline 18F-FDG PET/CT | 10 (18) |
| N/A | 1 (2) |
| Outcome | n= 57 (%) |
|---|---|
| Clinical response to ax-cel | |
| CR by last follow-up | 35 (61) |
| ORR by last follow-up | 52 (91) |
| ORR at 3 months | 31 (54) |
| ORR at 6 months | 26 (46) |
| Follow-up and survival | |
| Median follow-up for survivors in months (range) | 20.7 (2.7-32.9) |
| Median OS in months (95% CIs) | Not reached |
| Median PFS in months (95% CIs) | 13.4 (12.2-13.5) |
| Toxicity, grade | |
| CRS 1-3 | 50 (88) |
| 3 | 1 (2) |
| N/A | 3 (5) |
| CRES 1-4 | 30 (53) |
| 3-4 | 15 (26) |
| N/A | 3 (5) |
CRES, CAR-T-cell-related encephalopathy syndrome; CRP, C-reactive protein; CRS, cytokine release syndrome; DLBCL, diffuse large B-cell lymphoma; ECOG, Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase; IPI, International Prognostic Index; N/A, not applicable; NOS, not otherwise specified; ORR, overall response rate; ULN, upper limit or normal.