Table 1 Landmark trials of novel agents approved as single agents in B cell ALL
Drug | Study (phase) | Mechanism of action | Approved indication | Date of FDA approval | N | Median age, years [range] | CR/CRi rates, % | MRD negativity, % | Median RFS, months | Median OS, months | Reference |
|---|---|---|---|---|---|---|---|---|---|---|---|
Inotuzomab ozogamicin | IN-NOVATE (III) | ADC anti-CD22 | R/R B cell ALL | August 2017 | 109 | 47 [18-78] | 81 | 78 | 5.0 (PFS) | 7.7 | [12] |
Blinatumomab | TOWER (III) | BiTE anti CD3/CD19 | R/R B cell ALL | September 2016 | 271 | 41 [18-80] | 44 | 76 | NR | 7.7 | [13] |
Blinatumomab | ALCANTARA (II); Ph-positive ALL only | BiTE anti CD3/CD19 | R/R B cell ALL | July 2017 | 45 | 55 [23-78] | 36 | 88 | 6.7 | 7.1 | [14] |
Blinatumomab | BLAST (II) | BiTE anti CD3/CD19 | MRD + ≥ 0.1% B cell ALL | March 2018 | 113 | 45 [18-76] | N/A | 78 | 54% at 18 months | 36.5 | [15] |
Tisagenlecleucel | ELIANA (II) | Anti-CD19 CAR T cells | CD19+ B cell ALL that is refractory or in second or later relapse in patients up to 25 years of age | August 2017 | 75 | 11 [3-23] | 81 | 100 | 59% at 12 months | 19.1 | [16] |