Patient characteristics
| Characteristics N (%)/median [range] . | Full cohort N = 26 . | Ph-negative B-ALL N = 10 . | Ph-positive B-ALL N = 16 . |
|---|---|---|---|
| Age (y) | 46 [19-70] | 43 [19-67] | 46 [26-70] |
| Sex | |||
| Males | 12 (46) | 5 (50) | 7 (44) |
| Females | 14 (54) | 5 (50) | 9 (56) |
| Remission status | |||
| CR1 | 19 (73) | 5 (50) | 14 (88) |
| ≥CR2 | 7 (27) | 5 (50) | 2 (13) |
| Prior therapy | |||
| Blinatumomab | 13 (50) | 4 (40) | 9 (56) |
| ASCT | 5 (19) | 3 (30) | 2 (13) |
| CAR T cells | 1 (4) | 1 (10) | 0 |
| Preinotuzumab MRD | |||
| MFC (%) | 0.03 [0-1.24] | 0.21 [0.05-1.24]∗ | 0.001 [0-1.15] |
| BCR::ABL1 (%) | — | — | 0.22 [0-18.97]† |
| BCR::ABL1 TKI‡ | |||
| Ponatinib | 14 (88) | ||
| Dasatinib | 2 (13) | ||
| CD22 on flow MRD | 96.6 [62.9-99.9] | 93.3 [65-99.9] | 97.1 [62.9-99.9] |
| Median number of cycles on therapy | 3 [1-6] | 3 [1-5] | 4 [1-6] |
| Characteristics N (%)/median [range] . | Full cohort N = 26 . | Ph-negative B-ALL N = 10 . | Ph-positive B-ALL N = 16 . |
|---|---|---|---|
| Age (y) | 46 [19-70] | 43 [19-67] | 46 [26-70] |
| Sex | |||
| Males | 12 (46) | 5 (50) | 7 (44) |
| Females | 14 (54) | 5 (50) | 9 (56) |
| Remission status | |||
| CR1 | 19 (73) | 5 (50) | 14 (88) |
| ≥CR2 | 7 (27) | 5 (50) | 2 (13) |
| Prior therapy | |||
| Blinatumomab | 13 (50) | 4 (40) | 9 (56) |
| ASCT | 5 (19) | 3 (30) | 2 (13) |
| CAR T cells | 1 (4) | 1 (10) | 0 |
| Preinotuzumab MRD | |||
| MFC (%) | 0.03 [0-1.24] | 0.21 [0.05-1.24]∗ | 0.001 [0-1.15] |
| BCR::ABL1 (%) | — | — | 0.22 [0-18.97]† |
| BCR::ABL1 TKI‡ | |||
| Ponatinib | 14 (88) | ||
| Dasatinib | 2 (13) | ||
| CD22 on flow MRD | 96.6 [62.9-99.9] | 93.3 [65-99.9] | 97.1 [62.9-99.9] |
| Median number of cycles on therapy | 3 [1-6] | 3 [1-5] | 4 [1-6] |
B-ALL, B-cell ALL; CAR T cells, chimeric antigen receptor T-cell therapy.
Five patients had a MRD level between 1 × 10−4 and 1 × 10−3 by MFC and five ≥1 × 10−3 before starting inotuzumab.
Six patients had a MRD level between 1 × 10−4 and 1 × 10−3 by PCR and 10 ≥1 × 10−3 before starting inotuzumab.
Ponatinib and dasatinib were administered before the initiation of inotuzumab and were continued during study treatment.