Patient characteristics, efficacy, and safety
| Characteristic . | ≥65 y (n = 27) . | <65 y (n = 81) . |
|---|---|---|
| Median age (range), y | 69 (65-76) | 55 (23-64) |
| Male, n (%) | 22 (81) | 51 (63) |
| ECOG performance status 1, n (%) | 16 (59) | 46 (57) |
| Disease stage III/IV, n (%) | 22 (81) | 68 (84) |
| IPI score 3-4, n (%) | 19 (70) | 29 (36) |
| ≥3 Prior therapies, n (%) | 18 (67) | 58 (72) |
| Median tumor burden by SPD (range), mm2 | 3 790 (600-16 764) | 3 574 (171-23 297) |
| Disease type, n (%) | ||
| DLBCL | 20 (74) | 64 (79) |
| PMBCL | 0 | 8 (10) |
| TFL | 7 (26) | 9 (11) |
| Prior ASCT, n (%) | 5 (19) | 24 (30) |
| Refractory subgroup before enrollment, n (%) | ||
| Primary refractory | 1 (4) | 2 (2) |
| Refractory to second-lineor later therapy | 21 (78) | 59 (73) |
| Relapse after ASCT | 5 (19) | 20 (25) |
| Grade ≥3 AEs* | ||
| Any grade ≥3 AE, n (%) | 27 (100) | 79 (98) |
| Neutropenia† | 20 (74) | 66 (81) |
| Anemia | 13 (48) | 36 (44) |
| Thrombocytopenia‡ | 12 (44) | 31 (38) |
| Decreased white blood cell count | 9 (33) | 22 (27) |
| Encephalopathy | 8 (30) | 17 (21) |
| Lymphocyte count decreased | 8 (30) | 14 (17) |
| Grade ≥3 infection | ||
| Infection, n (%) | 5 (19) | 25 (31) |
| Grade ≥3 CRS§ | ||
| Any grade ≥3 CRS, n (%) | 2 (7) | 10 (12) |
| Pyrexia | 3 (12) | 9 (12) |
| Hypotension | 2 (8) | 8 (11) |
| Hypoxia | 3 (12) | 6 (7) |
| Grade ≥3 neurologic event§ | ||
| Any grade ≥3 neurologic event, n (%) | 12 (44) | 23 (28) |
| Encephalopathy | 8 (30) | 17 (21) |
| Confusional state | 2 (7) | 8 (10) |
| Aphasia | 0 | 8 (10) |
| Agitation | 3 (11) | 2 (2) |
| Delirium | 3 (11) | 0 |
| Characteristic . | ≥65 y (n = 27) . | <65 y (n = 81) . |
|---|---|---|
| Median age (range), y | 69 (65-76) | 55 (23-64) |
| Male, n (%) | 22 (81) | 51 (63) |
| ECOG performance status 1, n (%) | 16 (59) | 46 (57) |
| Disease stage III/IV, n (%) | 22 (81) | 68 (84) |
| IPI score 3-4, n (%) | 19 (70) | 29 (36) |
| ≥3 Prior therapies, n (%) | 18 (67) | 58 (72) |
| Median tumor burden by SPD (range), mm2 | 3 790 (600-16 764) | 3 574 (171-23 297) |
| Disease type, n (%) | ||
| DLBCL | 20 (74) | 64 (79) |
| PMBCL | 0 | 8 (10) |
| TFL | 7 (26) | 9 (11) |
| Prior ASCT, n (%) | 5 (19) | 24 (30) |
| Refractory subgroup before enrollment, n (%) | ||
| Primary refractory | 1 (4) | 2 (2) |
| Refractory to second-lineor later therapy | 21 (78) | 59 (73) |
| Relapse after ASCT | 5 (19) | 20 (25) |
| Grade ≥3 AEs* | ||
| Any grade ≥3 AE, n (%) | 27 (100) | 79 (98) |
| Neutropenia† | 20 (74) | 66 (81) |
| Anemia | 13 (48) | 36 (44) |
| Thrombocytopenia‡ | 12 (44) | 31 (38) |
| Decreased white blood cell count | 9 (33) | 22 (27) |
| Encephalopathy | 8 (30) | 17 (21) |
| Lymphocyte count decreased | 8 (30) | 14 (17) |
| Grade ≥3 infection | ||
| Infection, n (%) | 5 (19) | 25 (31) |
| Grade ≥3 CRS§ | ||
| Any grade ≥3 CRS, n (%) | 2 (7) | 10 (12) |
| Pyrexia | 3 (12) | 9 (12) |
| Hypotension | 2 (8) | 8 (11) |
| Hypoxia | 3 (12) | 6 (7) |
| Grade ≥3 neurologic event§ | ||
| Any grade ≥3 neurologic event, n (%) | 12 (44) | 23 (28) |
| Encephalopathy | 8 (30) | 17 (21) |
| Confusional state | 2 (7) | 8 (10) |
| Aphasia | 0 | 8 (10) |
| Agitation | 3 (11) | 2 (2) |
| Delirium | 3 (11) | 0 |
| Efficacy outcomes . | ≥65 y (n = 24) . | <65 y (n = 77) . |
|---|---|---|
| Investigator-assessed ORR, n (%) | 22 (92) | 62 (81) |
| Complete response | 18 (75) | 41 (53) |
| Partial response | 4 (17) | 21 (27) |
| Ongoing response, n (%)ǁ | 10 (42) | 29 (38) |
| 24-Mo overall survival rate, % | 54 | 49 |
| Efficacy outcomes . | ≥65 y (n = 24) . | <65 y (n = 77) . |
|---|---|---|
| Investigator-assessed ORR, n (%) | 22 (92) | 62 (81) |
| Complete response | 18 (75) | 41 (53) |
| Partial response | 4 (17) | 21 (27) |
| Ongoing response, n (%)ǁ | 10 (42) | 29 (38) |
| 24-Mo overall survival rate, % | 54 | 49 |
CRS, cytokine release syndrome; ECOG, Eastern Cooperative Oncology Group; PMBCL, primary mediastinal B-cell lymphoma; SPD, sum of product diameter; TFL, transformed follicular lymphoma.
Most common grade ≥3 AEs that occurred in ≥25% of either age group.
Neutropenia included the terms neutropenia, febrile neutropenia, and neutrophil count decreases.
Thrombocytopenia included the terms thrombocytopenia and platelet count decreases.
Symptoms shown are those that occurred in ≥10% of patients in either age group.
Patients in response as of the data cutoff.