Clinical trials with blinatumomab
| Study . | N . | Median age (range), y . | Prior allo-HCT,% . | Disease setting . | EMD, % . | CR/CRi/CRh% (MRD− %) . | Post-blinatumomab allo-HCT in responders, % . | Relapse, % . | Survival . | CD19− relapse, % . | EMD relapse . | Ref. . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MRD pilot | 20 | 47 (20-77) | 0 | MRD+ | 0 | NA (80) | 9 (45) | 8 (50) | 5- y RFS = 50% | 2 (25) | 2 (25) | 31, 54 |
| BLAST | 116 | 45 (18-76) | 0 | MRD+ | 0 | NA (78) | 74 (67) | 38 (43) | Median RFS = 18.9 mo | NR | NR | 34 |
| Median OS = 36.5 mo | ||||||||||||
| Phase 2 pilot | 36 | 32 (18-77) | 15 (42) | r/r | NR | 69 (88) | 13 (52) | 10 (40) | Median RFS = 7.6 mo | 3 (30) | 3 (30) | 30 |
| Median OS = 9.8 mo | ||||||||||||
| Phase 2 confirmatory | 189 | 39 (18-79) | 64 (34) | r/r | NR | 43 (82) | 32 (40) | 37 (46) | Median RFS = 5.9 mo | NR | NR | 18 |
| Median OS = 6.1 mo | ||||||||||||
| ALCANTARA | 45 | 55 (23-78) | 20 (44) | r/r | NR | 36 (88) | 7 (44) | 8 (50) | Median RFS = 6.7 mo | NR | NR | 35 |
| Median OS = 7.1 mo | ||||||||||||
| Phase 3 randomized study | 271 | 41 (18-80) | 94 (35) | r/r | NR | 44 (76) | 38 (14) | NR | 6-mo EFS = 31% | NR | NR | 33 |
| Median OS = 7.7 mo | ||||||||||||
| Pediatric study | 70 | 8 (<1-17) | 40 (57) | r/r | NR | 39 (52) | 13 (48) | 15 (56) | Median RFS = 4.4 mo | 4 (27) | NR | 20 |
| Median OS = 7.5 mo | ||||||||||||
| COH retrospective study | 65 | 33 (7-74) | 17 (26) | r/r | 10 (15) | 51 (63) | 15 (45) | 20 (61) | Median EFS = 6.3 mo | 6 (30) | 8 (40) | 19 |
| Study . | N . | Median age (range), y . | Prior allo-HCT,% . | Disease setting . | EMD, % . | CR/CRi/CRh% (MRD− %) . | Post-blinatumomab allo-HCT in responders, % . | Relapse, % . | Survival . | CD19− relapse, % . | EMD relapse . | Ref. . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MRD pilot | 20 | 47 (20-77) | 0 | MRD+ | 0 | NA (80) | 9 (45) | 8 (50) | 5- y RFS = 50% | 2 (25) | 2 (25) | 31, 54 |
| BLAST | 116 | 45 (18-76) | 0 | MRD+ | 0 | NA (78) | 74 (67) | 38 (43) | Median RFS = 18.9 mo | NR | NR | 34 |
| Median OS = 36.5 mo | ||||||||||||
| Phase 2 pilot | 36 | 32 (18-77) | 15 (42) | r/r | NR | 69 (88) | 13 (52) | 10 (40) | Median RFS = 7.6 mo | 3 (30) | 3 (30) | 30 |
| Median OS = 9.8 mo | ||||||||||||
| Phase 2 confirmatory | 189 | 39 (18-79) | 64 (34) | r/r | NR | 43 (82) | 32 (40) | 37 (46) | Median RFS = 5.9 mo | NR | NR | 18 |
| Median OS = 6.1 mo | ||||||||||||
| ALCANTARA | 45 | 55 (23-78) | 20 (44) | r/r | NR | 36 (88) | 7 (44) | 8 (50) | Median RFS = 6.7 mo | NR | NR | 35 |
| Median OS = 7.1 mo | ||||||||||||
| Phase 3 randomized study | 271 | 41 (18-80) | 94 (35) | r/r | NR | 44 (76) | 38 (14) | NR | 6-mo EFS = 31% | NR | NR | 33 |
| Median OS = 7.7 mo | ||||||||||||
| Pediatric study | 70 | 8 (<1-17) | 40 (57) | r/r | NR | 39 (52) | 13 (48) | 15 (56) | Median RFS = 4.4 mo | 4 (27) | NR | 20 |
| Median OS = 7.5 mo | ||||||||||||
| COH retrospective study | 65 | 33 (7-74) | 17 (26) | r/r | 10 (15) | 51 (63) | 15 (45) | 20 (61) | Median EFS = 6.3 mo | 6 (30) | 8 (40) | 19 |
COH, City of Hope; CR, complete remission; CRh, CR with incomplete hematological recovery; CRi, CR with incomplete count recovery; EFS, event-free survival; EMD, extramedullary disease; MRD−, negative minimal residual disease; N, number; NA, not applicable; NR, not reported; OS, overall survival; Ref., reference; RFS, relapse-free survival.