Table 1.
Major clinical trials for blinatumomab
| Study | n | Median age (range), y | CR,* % | MRD-CR, % | Relapse, % | RFS, median | OS, median |
|---|---|---|---|---|---|---|---|
| MRD pilot50,51 | 20 | 47 (20-77) | NA | 80 | 50 | 5-y = 50% | NR |
| BLAST trial52 | 116 | 45 (18-76) | NA | 78 | 43 | 18.9 mo | 36.5 mo |
| Phase 2 pilot5 | 36 | 32 (18-77) | 69 | 88 | 40 | 7.6 mo | 9.8 mo |
| Phase 2 confirmatory6 | 189 | 39 (18-79) | 43 | 82 | 46 | 5.9 mo | 6.1 mo |
| ALCANTARA trial7 | 45 | 55 (23-78) | 36 | 88 | 50 | 6.7 mo | 7.1 mo |
| Phase 38 | 271 | 41 (18-80) | 44 | 76 | NR | 6-mo = 31%† | 7.7 mo |
| Pediatric trial10 | 70 | 8 (<1-17) | 39 | 52 | 56 | 4.4 mo | 7.5 mo |
| City of Hope retrospective9 | 65 | 33 (7-74) | 51 | 63 | 61 | 6.3 mo | NR |
NA, not available; NR, not reported; OS, overall survival; RFS, relapse free survival.
*CR (complete remission) is inclusive of CR with count recovery, as well as CR with incomplete hematologic recovery and CR with incomplete count recovery.
†
EFS (event-free survival).