Table 2.
Blinatumomab Clinical Trial Data in B-Cell ALL
| Population | N | Regimen | Prior HSCT | ≥ 2nd Salvage | Response | MRD Response | Median Overall Survival | Grade 3+ CNS (%) | Grade 3+ CRS (%) | Ref. |
|---|---|---|---|---|---|---|---|---|---|---|
| R/R Ph- | 36 | BLN | 42% | 21% | CR/CRh: 69% | 88% | 9.8 | 16% | 6% | [23] |
| R/R Ph- | 189 | BLN | 34% | 39% | CR/CRh: 43% | 82% | 6.1 | 11% | 2% | [26] |
| R/R Ph- | 405 | BLN vs CT | 34% | 45% | CR: 34% CR/CRh/CRi: 44% | 76% | 7.7 | 9% | 5% | [27] |
| R/R Ph- | 84 | h-CVD, INO, ± BLN | 23% | 42% | CR/CRi/CRp: 80% | 80% | 11.0 | – | – | [29] |
| R/R Ph+ | 45 | BLN | 44% | 82% | CR: 31% CR/CRh: 36% | 88% | 7.1 | 7% | 0% | [36] |
| MRD+ | 21 | BLN | 0% | – | 80% | – | 19% | 0% | [45] | |
| MRD+ | 116 | BLN | 0% | 36% | – | 78% | 36.5 | 13% | 2% | [47] |
| Frontline, Ph-, younger | 27 | H-CVAD + BLN | – | CR: 100% | 96% | 89% (1y OS) | 17% | 5% | [50] | |
| Frontline, Ph-, older | 64 | h-CVD, INO, ± BLN | – | CR/CRi/CRp: 98% | 94% | 54% (3y OS) | – | – | [51] | |
| Frontline, Ph+ | 63 | BLN + TKI | – | CMR/PNQD: 80% | 100% | 94% (1y OS) | – | – | [53] |
Abbreviations: N, number of patients enrolled; HSCT, hematopoietic stem cell transplant; MRD, minimal residual disease; CNS, central nervous system adverse events; CRS, cytokine release syndrome; Ref., reference number; R/R, relapsed/refractory; Ph, Philadelphia chromosome; BLN, blinatumomab; CT, chemotherapy; h-CVD, mini hyper-CVD; INO, inotuzumab ozogamicin; H-CVAD, hyper-CVAD; TKI, tyrosine kinase inhibitor; CR, complete response; CRh, complete response with partial hematologic recovery; CRi, complete response with incomplete hematologic recovery; CRp, complete response without platelet recovery; PNQD, positive non-quantifiable disease; OS, overall survival.