Table 3.
Clinical efficacy of blinatumomab in R/R B-cell precursor ALL
| Study | CR/CRh ratea (%) (95% CI) | CR rateb (%) (95% CI) | CRh ratec(%) (95% CI) | MRD negativityd (%) (95% CI) | Median OS (mo) (95% CI) | Median RFS (mo) (95% CI) |
|---|---|---|---|---|---|---|
| Adults | ||||||
| NCT01209286 (MT103-206) [25] | 69 (52–84)e | 42 (26–59) | 28 (14–45) | 88g | 10 (9–15) | 8 (5–10) |
| NCT01466179 (MT103-211) [20, 26] | 43 (36–50)e | 33 (27–41) | 10 (6–15) | 82 (72–90) | 6 (4–8) | 6 (5–8) |
| NCT02013167 (TOWER) [13, 33] | 42 (37–49) | 34 (28–40) | 9 (6–13) | 76 | 8 (6–10)e | NA |
| NCT02000427 (ALCANTARA) [22] | 36 (22–51)e | 31 (18–47) | 4 (1–15) | 88 (62–98) | 7 (6–NE) | 7 (4–NE) |
| Pediatrics/adolescents | ||||||
| NCT01471782 (MT103-205) [23, 24, 33] | 33 (22–45)f | 17 (9–28)e,f | 16 (8–26)f | 43 (23–66)h | 8 (4–12) | 6 (0.5–16) |
ALL acute lymphoblastic leukemia, CI confidence interval, CR complete remission, CRh CR with partial hematologic recovery, mo months, MRD minimal residual disease, NA not applicable, NE not estimable, OS overall survival, RFS relapse-free survival, R/R relapsed/refractory
aCR/CRh rate = number of patients with either CR or CRh within the first 2 treatment cycles divided by the total number of patients in the analysis set
bCR rate = number of patients with CR within the first 2 treatment cycles divided by the total number of patients in the analysis set
cCRh rate = number of patients with CRh within the first 2 treatment cycles divided by the total number of patients in the analysis set
dMRD negativity defined as < 10−4 detectable blasts; calculated as the percentage of CR/CRh responders with MRD assessment
ePrimary endpoint
fCR defined as ≤ 5% of blasts in the bone marrow, no evidence of circulating blasts or extra-medullary disease, and full recovery of peripheral blood counts (platelets > 100,000/µL and absolute neutrophil counts [ANC] > 1000/µL). CRh defined as ≤ 5% of blasts in the bone marrow, no evidence of circulating blasts or extra-medullary disease, and partial recovery of peripheral blood counts (platelets > 50,000/µL and ANC > 500/µL)
gAcross cycles 1–3
hNumber of patients who achieved MRD response and the respective remission status/number of patients who achieved the respective remission status. One CR/CRh responder with missing MRD status considered as MRD-nonresponder