Summary of phase 1 and 2 studies of loncastuximab tesirine in r/r DLBCL
| Parameter . | Phase 1* . | Phase 2 . |
|---|---|---|
| No. of patients | 139 | 145 |
| Median age, y | 63 | 66 |
| Double/triple hit, no. | 23 (17%) | 15 (10%) |
| Transformed DLBCL | 37 (27%) | 29 (20%) |
| Median number of prior therapies, no. (range) | 3 (1-10) | 3 (2-4) |
| Prior auto-SCT, no. | 22 (16%) | 21 (14%) |
| Prior CAR T cells, no. | 2 (1%) | 13 (9%) |
| ORR | 42.3% | 48.3% |
| Complete remission | 23.4% | 24.1% |
| Median duration of response, mo | 4.5 (not reached for complete responders) | 10.3 (13.4 mo for complete responders) |
| Median PFS, mo | 2.8 | 4.9 |
| Median OS, mo | 7.5 | 9.9 |
| Time to response, d | 43 | 41 |
| Stopped drug from adverse event, no. | 35 (19%) | 34 (23%) |
| Grade ≥ 3 neutropenia, no. | 71 (40%) | 37 (26%) |
| Grade ≥ 3 pleural effusions, no. | 7 (4%) | 3 (2%) |
| Rash, no. | 45 (24.6%) | 19 (13%), only 1 case grade 3 |
| Grade ≥ 3 elevation of GGT, no. | 39 (21.3%) | 24 (16%) |
| Parameter . | Phase 1* . | Phase 2 . |
|---|---|---|
| No. of patients | 139 | 145 |
| Median age, y | 63 | 66 |
| Double/triple hit, no. | 23 (17%) | 15 (10%) |
| Transformed DLBCL | 37 (27%) | 29 (20%) |
| Median number of prior therapies, no. (range) | 3 (1-10) | 3 (2-4) |
| Prior auto-SCT, no. | 22 (16%) | 21 (14%) |
| Prior CAR T cells, no. | 2 (1%) | 13 (9%) |
| ORR | 42.3% | 48.3% |
| Complete remission | 23.4% | 24.1% |
| Median duration of response, mo | 4.5 (not reached for complete responders) | 10.3 (13.4 mo for complete responders) |
| Median PFS, mo | 2.8 | 4.9 |
| Median OS, mo | 7.5 | 9.9 |
| Time to response, d | 43 | 41 |
| Stopped drug from adverse event, no. | 35 (19%) | 34 (23%) |
| Grade ≥ 3 neutropenia, no. | 71 (40%) | 37 (26%) |
| Grade ≥ 3 pleural effusions, no. | 7 (4%) | 3 (2%) |
| Rash, no. | 45 (24.6%) | 19 (13%), only 1 case grade 3 |
| Grade ≥ 3 elevation of GGT, no. | 39 (21.3%) | 24 (16%) |
OS, overall survival; PFS, progression-free survival; SCT, stem cell transplant.
Only the DLBCL cohort was considered for patient characteristics and outcomes; safety analysis refers to all patients included in the study.