Baseline patient characteristics at the time of axi-cel infusion and clinical outcomes with axi-cel
| Characteristic . | Cohort 1 (n = 48) . | Cohort 2 (n = 48) . | P . |
|---|---|---|---|
| Age, median (range), y | 63 (28-76) | 64 (19-79) | .83 |
| Sex, male | 31 (65) | 30 (62.5) | .83 |
| ECOG (0-5) | |||
| 0-1 | 41 (86) | 37 (77) | .29 |
| 2-3 | 7 (14) | 11 (23) | |
| Histology | |||
| Diffuse LBCL, not otherwise specified | 26 (54) | 21 (44) | .25 |
| GCB [cases with unknown double-hit/triple-hit status] | 10 (21) [1] | 10 (21) [4] | 1.00 |
| ABC [cases with unknown double-hit/triple-hit status] | 13 (27) [2] | 8 (17) [2] | .23 |
| Unknown if GCB or ABC [cases with unknown double-hit/triple-hit status] | 3 (6) [0] | 3 (6) [1] | 1.00 |
| High grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements | 7 (15) | 8 (17) | .79 |
| B-cell lymphoma, unclassifiable, with features intermediate between diffuse LBCL and classical Hodgkin lymphoma | 12 (25) | 17 (35) | .28 |
| Primary mediastinal B-cell lymphoma | 3 (6) | 2 (4) | .65 |
| Stage | |||
| I/II | 10 (21) | 12 (25) | .62 |
| III/IV | 38 (79) | 36 (75) | |
| LDH level before conditioning >2×ULN | 11 (23) | 9 (19) | .61 |
| Extranodal sites >1 | 24 (50) | 33 (69) | .06 |
| Secondary R-IPI score (1-5) | |||
| 0 | 1 (2) | 2 (4) | .50 |
| 1-2 | 18 (38) | 12 (25) | |
| 3-5 | 26 (54) | 32 (67) | |
| N/A (primary mediastinal B-cell lymphoma) | 3 (6) | 2 (4) | |
| Prior lines of therapy, median, range | 3, 2-7 | 3, 2-8 | .83 |
| Bridging therapy | |||
| Yes | 15 (31) | 31 (65) | .01 |
| Chemotherapy/targeted therapy | 2 (4) | 10 (21) | |
| Steroids | 5 (10) | 4 (8) | |
| Radiation therapy | 1 (2) | 4 (8) | |
| Combination chemotherapy/targeted therapy ± steroids ± radiation therapy | 7 (15) | 13 (27) | |
| Received prior to baseline PET/CT | 7 (15) | 17 (35) | .02 |
| Axi-cel administration | |||
| Trial | 22 (46) | 0 (0) | <.0001 |
| Commercial (Yescarta) | 26 (54) | 48 (100) | |
| Clinical response to axi-cel | |||
| CR by last follow-up | 32 (67) | 31 (65) | .83 |
| ORR by last follow-up | 39 (81) | 35 (73) | .33 |
| ORR at 3 mo | 26 (54) | 25/47 (53) | |
| ORR at 6 mo | 23 (48) | 20/47(43) | |
| ORR at 12 mo | 21 (44) | ||
| Median follow-up for survivors (range), mo | 24.98 (10.59-51.02) | 12.03 (0.89-25.74) | 1.00 |
| Median OS (95% CI), mo | 34.98 (14.33-34.98) | Not reached | |
| Median PFS (95% CI), mo | 5.85 (2.99-11.54) | 13.84 (3.95-13.84) | .54 (log rank) |
| Toxicity, G0-5 | |||
| CRS | 45 (94) | 45 (94) | 1.00 |
| G3-4 CRS | 2 (4) | 7 (15) | .08 |
| NT | 32 (67) | 35 (73) | .50 |
| G3-4 NT | 12 (25) | 16 (33) | .37 |
| Characteristic . | Cohort 1 (n = 48) . | Cohort 2 (n = 48) . | P . |
|---|---|---|---|
| Age, median (range), y | 63 (28-76) | 64 (19-79) | .83 |
| Sex, male | 31 (65) | 30 (62.5) | .83 |
| ECOG (0-5) | |||
| 0-1 | 41 (86) | 37 (77) | .29 |
| 2-3 | 7 (14) | 11 (23) | |
| Histology | |||
| Diffuse LBCL, not otherwise specified | 26 (54) | 21 (44) | .25 |
| GCB [cases with unknown double-hit/triple-hit status] | 10 (21) [1] | 10 (21) [4] | 1.00 |
| ABC [cases with unknown double-hit/triple-hit status] | 13 (27) [2] | 8 (17) [2] | .23 |
| Unknown if GCB or ABC [cases with unknown double-hit/triple-hit status] | 3 (6) [0] | 3 (6) [1] | 1.00 |
| High grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements | 7 (15) | 8 (17) | .79 |
| B-cell lymphoma, unclassifiable, with features intermediate between diffuse LBCL and classical Hodgkin lymphoma | 12 (25) | 17 (35) | .28 |
| Primary mediastinal B-cell lymphoma | 3 (6) | 2 (4) | .65 |
| Stage | |||
| I/II | 10 (21) | 12 (25) | .62 |
| III/IV | 38 (79) | 36 (75) | |
| LDH level before conditioning >2×ULN | 11 (23) | 9 (19) | .61 |
| Extranodal sites >1 | 24 (50) | 33 (69) | .06 |
| Secondary R-IPI score (1-5) | |||
| 0 | 1 (2) | 2 (4) | .50 |
| 1-2 | 18 (38) | 12 (25) | |
| 3-5 | 26 (54) | 32 (67) | |
| N/A (primary mediastinal B-cell lymphoma) | 3 (6) | 2 (4) | |
| Prior lines of therapy, median, range | 3, 2-7 | 3, 2-8 | .83 |
| Bridging therapy | |||
| Yes | 15 (31) | 31 (65) | .01 |
| Chemotherapy/targeted therapy | 2 (4) | 10 (21) | |
| Steroids | 5 (10) | 4 (8) | |
| Radiation therapy | 1 (2) | 4 (8) | |
| Combination chemotherapy/targeted therapy ± steroids ± radiation therapy | 7 (15) | 13 (27) | |
| Received prior to baseline PET/CT | 7 (15) | 17 (35) | .02 |
| Axi-cel administration | |||
| Trial | 22 (46) | 0 (0) | <.0001 |
| Commercial (Yescarta) | 26 (54) | 48 (100) | |
| Clinical response to axi-cel | |||
| CR by last follow-up | 32 (67) | 31 (65) | .83 |
| ORR by last follow-up | 39 (81) | 35 (73) | .33 |
| ORR at 3 mo | 26 (54) | 25/47 (53) | |
| ORR at 6 mo | 23 (48) | 20/47(43) | |
| ORR at 12 mo | 21 (44) | ||
| Median follow-up for survivors (range), mo | 24.98 (10.59-51.02) | 12.03 (0.89-25.74) | 1.00 |
| Median OS (95% CI), mo | 34.98 (14.33-34.98) | Not reached | |
| Median PFS (95% CI), mo | 5.85 (2.99-11.54) | 13.84 (3.95-13.84) | .54 (log rank) |
| Toxicity, G0-5 | |||
| CRS | 45 (94) | 45 (94) | 1.00 |
| G3-4 CRS | 2 (4) | 7 (15) | .08 |
| NT | 32 (67) | 35 (73) | .50 |
| G3-4 NT | 12 (25) | 16 (33) | .37 |
Values are presented as n (%) of patients, unless otherwise indicated.
ABC, activated B-cell like; GCB, germinal center B-cell like; R-IPI, revised International Prognostic Index.