Table 3.
Main results of clinical trials with blinatumomab in ALL.
| Type of ALL | Ph-positive, R/R adults | Ph-negative, R/R adults | Positive MRD, adults | Ph-negative, R/R, children | Ph-negative, R/R, children | ||
|---|---|---|---|---|---|---|---|
| Study | Pivotal phase II (ALCANTARA) | First phase II | Confirmatory phase II | phase III TOWER |
phase II BLAST |
phase I/II Study 205 |
phase II expanded access (RIALTO) |
| Patients (N) | 45 | 36 | 189 | 271 | 116 | 70 | 98 |
| CR/CRh (%) | 36 | 69 | 43 | 45 | NA | 39 | 60 |
| MRD level <0.01% | 88 | 88 | 82 | 76 | 78 | 54 | 48 |
| OS, median, months | 7.1 | 9.8 | 6.1 | 7.7 | 36.5 | 7.5 | 13 |
ALL, acute lymphoblastic leukemia; CR, complete remission; CRh, complete remission with incomplete hematologic recovery; MRD, measurable residual disease; OS, overall survival; R/R, relapsed or refractory.