Approved uses for antibody therapy in ALL
| Cell-surface antigen . | Antibody therapy . | Disease state . | Antibody dose and schedule . | Chemotherapy backbone or comparator . | N (all patients) . | CR (%) . | MRD (%) . | PFS . | OS . | Toxicities . |
|---|---|---|---|---|---|---|---|---|---|---|
| CD20 | Rituximab | Ph-negative newly diagnosed ALL6 | 375 mg/m2 IV during induction, consolidation, late intensification, and maintenance for a total of 16 infusions | Vincristine, steroids, anthracycline, cytarabine, methotrexate 6-mercaptopurine, cyclophosphamide, asparaginase, etoposide | 209 | 92 | 91 after first consolidation | 65% 2 y EFS | 71% at 2 y | Infusion reaction; hepatitis B reactivation |
| CD22 | IO | Ph-negative and positive R/R ALL: first or second salvage16 | Weekly IV infusion:0.8 mg/m2 IV on d 1, 0.5 mg/m2 IV d 8, 15; induction = 21 d cycle, subsequent cycles if in remission 0.5 mg/m2 d 1, 8, 15 in 28 d cycle for up to 6 cycles | Fludarabine, cytarabine, and GCSF (FLAG); high-dose cytarabine; cytarabine and mitoxantrone | 326 | 81 | 78 | 5 mo | 7.7 mo | Transaminitis, hyperbilirubinemia, VOD, thrombocytopenia |
| CD19 | Blinatumomab | Ph-negative and positive ALL in first or later CR with MRD ≥10−3 after intensive chemo25 | 15 μg/m2 daily for 28 d followed by 14 d off treatment of up to 4 cycles | None | 116 | NA | 78 | MRD responders 23.6 mo | MRD responders 38.9 mo | Fever, neurologic events |
| CD19 | Blinatumomab | Ph-negative relapse/refractory ALL: unlimited prior salvage therapies31 | 9 μg/d, d 1-7; 28 μg/d, d 8-28; 14 d off treatment of up to 5 cycles; 28 μg/d for 4 wk on, 8 wk off × 1 y for maintenance | Fludarabine, cytarabine, and GCSF (FLAG); high-dose cytarabine; high-dose methotrexate–based regimen; clofarabine-based regimen | 405 | 44 | 76 | EFS, 31% at 6 mo; median DOR, 7.3 mo | 7.7 mo | CRS; neurologic events |
| Cell-surface antigen . | Antibody therapy . | Disease state . | Antibody dose and schedule . | Chemotherapy backbone or comparator . | N (all patients) . | CR (%) . | MRD (%) . | PFS . | OS . | Toxicities . |
|---|---|---|---|---|---|---|---|---|---|---|
| CD20 | Rituximab | Ph-negative newly diagnosed ALL6 | 375 mg/m2 IV during induction, consolidation, late intensification, and maintenance for a total of 16 infusions | Vincristine, steroids, anthracycline, cytarabine, methotrexate 6-mercaptopurine, cyclophosphamide, asparaginase, etoposide | 209 | 92 | 91 after first consolidation | 65% 2 y EFS | 71% at 2 y | Infusion reaction; hepatitis B reactivation |
| CD22 | IO | Ph-negative and positive R/R ALL: first or second salvage16 | Weekly IV infusion:0.8 mg/m2 IV on d 1, 0.5 mg/m2 IV d 8, 15; induction = 21 d cycle, subsequent cycles if in remission 0.5 mg/m2 d 1, 8, 15 in 28 d cycle for up to 6 cycles | Fludarabine, cytarabine, and GCSF (FLAG); high-dose cytarabine; cytarabine and mitoxantrone | 326 | 81 | 78 | 5 mo | 7.7 mo | Transaminitis, hyperbilirubinemia, VOD, thrombocytopenia |
| CD19 | Blinatumomab | Ph-negative and positive ALL in first or later CR with MRD ≥10−3 after intensive chemo25 | 15 μg/m2 daily for 28 d followed by 14 d off treatment of up to 4 cycles | None | 116 | NA | 78 | MRD responders 23.6 mo | MRD responders 38.9 mo | Fever, neurologic events |
| CD19 | Blinatumomab | Ph-negative relapse/refractory ALL: unlimited prior salvage therapies31 | 9 μg/d, d 1-7; 28 μg/d, d 8-28; 14 d off treatment of up to 5 cycles; 28 μg/d for 4 wk on, 8 wk off × 1 y for maintenance | Fludarabine, cytarabine, and GCSF (FLAG); high-dose cytarabine; high-dose methotrexate–based regimen; clofarabine-based regimen | 405 | 44 | 76 | EFS, 31% at 6 mo; median DOR, 7.3 mo | 7.7 mo | CRS; neurologic events |
DOR, duration of remission; EFS, event-free survival; NA, not available; PFS, progression-free survival.