First-line studies containing blinatumomab and/or inotuzumab for the treatment of Ph-negative BCP-ALL
| Study . | Patients number . | Treatment . | Patient age (range) . | CR rate . | MRD-negative rate . | OS . | EFS/RFS/DFS . |
|---|---|---|---|---|---|---|---|
| ALLG ALL08 | 30 | Alternating cycles of blinatumomab/hyper-CVAD-like regimen (4 cycles) | 52 y (40-67) | 100% | Up to 83% | 69% (2 y) | EFS 62% (2 y) |
| ECOG ACRIN E1910 | 488 | Randomized study: conventional induction chemo followed by chemo or chemo + blinatumomab consolidation therapy | 51 y (30-70) | 81% | NA | Median OS: not reached vs 71.4 | NA |
| EWALL-InO | 131 | Inotuzumab + low-dose chemo induction followed by age-adapted chemotherapy | 68 y (55-84) | 90% | 90% | 54% (2 y) | LFS 50% (2 y) |
| GINEMA LAL2317 | 146 | Sequential chemotherapy (pediatric inspired chemotherapy), 2 cycles of blinatumomab consolidation | 41 y (30-70) | 90% | Up to 96% | 84% (12 mo) | DFS 72% (12 mo) |
| GMALL Bold | 33 | Alternating cycles of age-adapted chemo + blinatumomab as induction therapy | 65 y (56-76) | 76% | NA | 100% (1 y) | DFS 89% (1 y) |
| GRAALL-2014/B | 95 | Blinatumomab during consolidation and maintenance or as bridge to allogeneic SCT | 35 y (18-60) | NA | 74% | 92% (18 mo) | DFS 69% (18 mo) |
| INITIAL-1 | 45 | 3 cycles of inotuzumab induction therapy followed by age-adapted chemotherapy | 64 y (56-80) | 100% | up to 71% | 73% (3 y) | EFS 55% (3 y) |
| MDACC study NCT02877303 | 38 | Hyper-CVAD chemo followed by 4 cycles blinatumomab consolidation | 37 y (17-59) | 100% | up to 95% | 85% (3 y) | RFS 84% (3 y) |
| 20 | Addition of inotuzumab (amendment) | 24 y (18-47) | |||||
| MDACC study NCT01371630 | 50 | Inotuzumab + mini-CVAD | 68 y (60-81) | 98% | up to 94% | 54% (3 y) | PFS 58% (2 y) |
| 30 | With blinatumomab consolidation and maintenance | ||||||
| SWOG 1318 | 29 | Blinatumomab induction and consolidation followed by POMP maintenance | 75 y | 66% | NA | 37% (3 y) | DFS 37% (3 y) |
| Study . | Patients number . | Treatment . | Patient age (range) . | CR rate . | MRD-negative rate . | OS . | EFS/RFS/DFS . |
|---|---|---|---|---|---|---|---|
| ALLG ALL08 | 30 | Alternating cycles of blinatumomab/hyper-CVAD-like regimen (4 cycles) | 52 y (40-67) | 100% | Up to 83% | 69% (2 y) | EFS 62% (2 y) |
| ECOG ACRIN E1910 | 488 | Randomized study: conventional induction chemo followed by chemo or chemo + blinatumomab consolidation therapy | 51 y (30-70) | 81% | NA | Median OS: not reached vs 71.4 | NA |
| EWALL-InO | 131 | Inotuzumab + low-dose chemo induction followed by age-adapted chemotherapy | 68 y (55-84) | 90% | 90% | 54% (2 y) | LFS 50% (2 y) |
| GINEMA LAL2317 | 146 | Sequential chemotherapy (pediatric inspired chemotherapy), 2 cycles of blinatumomab consolidation | 41 y (30-70) | 90% | Up to 96% | 84% (12 mo) | DFS 72% (12 mo) |
| GMALL Bold | 33 | Alternating cycles of age-adapted chemo + blinatumomab as induction therapy | 65 y (56-76) | 76% | NA | 100% (1 y) | DFS 89% (1 y) |
| GRAALL-2014/B | 95 | Blinatumomab during consolidation and maintenance or as bridge to allogeneic SCT | 35 y (18-60) | NA | 74% | 92% (18 mo) | DFS 69% (18 mo) |
| INITIAL-1 | 45 | 3 cycles of inotuzumab induction therapy followed by age-adapted chemotherapy | 64 y (56-80) | 100% | up to 71% | 73% (3 y) | EFS 55% (3 y) |
| MDACC study NCT02877303 | 38 | Hyper-CVAD chemo followed by 4 cycles blinatumomab consolidation | 37 y (17-59) | 100% | up to 95% | 85% (3 y) | RFS 84% (3 y) |
| 20 | Addition of inotuzumab (amendment) | 24 y (18-47) | |||||
| MDACC study NCT01371630 | 50 | Inotuzumab + mini-CVAD | 68 y (60-81) | 98% | up to 94% | 54% (3 y) | PFS 58% (2 y) |
| 30 | With blinatumomab consolidation and maintenance | ||||||
| SWOG 1318 | 29 | Blinatumomab induction and consolidation followed by POMP maintenance | 75 y | 66% | NA | 37% (3 y) | DFS 37% (3 y) |
DFS, disease-free survival; NA, not available; PFS, progression-free survival; RFS, relapse-free survival.