Baseline patient characteristics, safety, and outcomes of patients with aggressive B-NHL receiving CD19-directed CAR-T
Characteristic . | . | Number (%) . |
---|---|---|
Number of patients | 514 | |
Age, y, median (range) | 59 (18-84) | |
Sex | Male | 305 (59%) |
ECOG PS at apheresis | 0-1 | 409 (80%) |
2 | 29 (6%) | |
3-4 | 6 (1%) | |
Unknown | 70 (14%) | |
Histologic subtype | De novo DLBCL | 357 (69%) |
Transformed follicular lymphoma | 98 (19%) | |
Richter’s transformation | 18 (3.5%) | |
Other∗ | 12 (2.3%) | |
Transformed marginal zone lymphoma | 10 (1.9%) | |
PMBL | 9 (1.8%) | |
PTLD | 5 (0.97%) | |
Gray zone lymphoma | 3 (0.58%) | |
Transformed mantle cell lymphoma | 2 (0.39%) | |
Number of previous lines of therapy | 1 | 58 (11%) |
2 | 225 (44%) | |
3-4 | 203 (39%) | |
5-6 | 25 (5%) | |
Unknown | 3 (1%) | |
IPI at apheresis | 0-1 | 99 (19%) |
2 | 95 (18%) | |
3 | 128 (25%) | |
4-5 | 73 (14%) | |
Unknown | 119 (23%) | |
LDH elevation at apheresis | Yes | 248 (48%) |
No | 115 (22%) | |
Unknown | 151 (29%) | |
Stage at apheresis | 1-2 | 84 (16%) |
3-4 | 418 (81%) | |
Unknown | 12 (2%) | |
Cell of origin | Germinal center B-cell like | 238 (46%) |
Nongerminal center B-cell like | 163 (32%) | |
Unknown | 113 (22%) | |
Double expressor/double hit status | Double hit† | 81 (16%) |
Double expressor‡ | 86 (17%) | |
None | 267 (52%) | |
Unknown | 80 (16%) | |
Previous autologous transplant | Yes | 139 (27%) |
No | 375 (73%) | |
CNS involvement at apheresis | Yes | 32 (6%) |
No | 470 (91%) | |
Unknown | 12 (2%) | |
CAR construct | Axi-cel | 330 (64%) |
Tisa-cel | 138 (27%) | |
Liso-cel | 45 (9%) | |
Unknown | 1 (0.2%) | |
CAR-T on clinical trial | Yes | 127 (25%) |
No | 387 (75%) | |
CRS | Any grade | 344 (67%) |
Grade 3+ | 62 (12%) | |
ICANS | Any grade | 236 (46%) |
Grade 3+ | 87 (17%) | |
Best response to CAR-T | ORR | 351 (68%) |
Complete response rate | 251 (49%) | |
Relapse | Late relapse (≥180 days) | 59 (11.5%) |
CD19 antigen | CD19 loss post–CAR-T failure | 14 (17%) |
No CD19 loss | 67 (83%) | |
Missing/not assessed | 173 |
Characteristic . | . | Number (%) . |
---|---|---|
Number of patients | 514 | |
Age, y, median (range) | 59 (18-84) | |
Sex | Male | 305 (59%) |
ECOG PS at apheresis | 0-1 | 409 (80%) |
2 | 29 (6%) | |
3-4 | 6 (1%) | |
Unknown | 70 (14%) | |
Histologic subtype | De novo DLBCL | 357 (69%) |
Transformed follicular lymphoma | 98 (19%) | |
Richter’s transformation | 18 (3.5%) | |
Other∗ | 12 (2.3%) | |
Transformed marginal zone lymphoma | 10 (1.9%) | |
PMBL | 9 (1.8%) | |
PTLD | 5 (0.97%) | |
Gray zone lymphoma | 3 (0.58%) | |
Transformed mantle cell lymphoma | 2 (0.39%) | |
Number of previous lines of therapy | 1 | 58 (11%) |
2 | 225 (44%) | |
3-4 | 203 (39%) | |
5-6 | 25 (5%) | |
Unknown | 3 (1%) | |
IPI at apheresis | 0-1 | 99 (19%) |
2 | 95 (18%) | |
3 | 128 (25%) | |
4-5 | 73 (14%) | |
Unknown | 119 (23%) | |
LDH elevation at apheresis | Yes | 248 (48%) |
No | 115 (22%) | |
Unknown | 151 (29%) | |
Stage at apheresis | 1-2 | 84 (16%) |
3-4 | 418 (81%) | |
Unknown | 12 (2%) | |
Cell of origin | Germinal center B-cell like | 238 (46%) |
Nongerminal center B-cell like | 163 (32%) | |
Unknown | 113 (22%) | |
Double expressor/double hit status | Double hit† | 81 (16%) |
Double expressor‡ | 86 (17%) | |
None | 267 (52%) | |
Unknown | 80 (16%) | |
Previous autologous transplant | Yes | 139 (27%) |
No | 375 (73%) | |
CNS involvement at apheresis | Yes | 32 (6%) |
No | 470 (91%) | |
Unknown | 12 (2%) | |
CAR construct | Axi-cel | 330 (64%) |
Tisa-cel | 138 (27%) | |
Liso-cel | 45 (9%) | |
Unknown | 1 (0.2%) | |
CAR-T on clinical trial | Yes | 127 (25%) |
No | 387 (75%) | |
CRS | Any grade | 344 (67%) |
Grade 3+ | 62 (12%) | |
ICANS | Any grade | 236 (46%) |
Grade 3+ | 87 (17%) | |
Best response to CAR-T | ORR | 351 (68%) |
Complete response rate | 251 (49%) | |
Relapse | Late relapse (≥180 days) | 59 (11.5%) |
CD19 antigen | CD19 loss post–CAR-T failure | 14 (17%) |
No CD19 loss | 67 (83%) | |
Missing/not assessed | 173 |
DLBCL, diffuse large B-cell lymphoma; ORR, overall response rate; PMBL, primary mediastinal large B-cell lymphoma; PTLD, posttransplant lymphoproliferative disorder.
Other histologies included: transformed lymphoplasmacytic lymphoma, T cell rich B-cell lymphoma, and Burkitt lymphoma.
MYC translocation with a concurrent BCL2 and/or BCL6 translocations.
Overexpression of MYC and BCL2 proteins.