Table 3:
Efficacy Results in Patients in Study ASTX727-01-B and Study ASTX727-02a
| ASTX7272-01-B (n = 80) |
ASTX727-02 (n = 133) |
|
|---|---|---|
| Complete remission | ||
| Number (%) | 14 (18%) | 28 (21%) |
| 95% CI | (10–28%) | (15–29%) |
|
| ||
| Median time to CR (range) | 4.8 (1.7, 10.0) months | 4.3 (2.1, 15.2) months |
|
| ||
| Median duration of CR (range) | 8.7 (1.1, 18.2) months | 7.5 (1.6, 17.5) months |
|
| ||
| Conversion from TD to TI b | ||
| Number (%) | 20/41 (49%) | 30/57 (53%) |
|
| ||
| Maintenance of TI c | ||
| Number (%) | 25/39 (64%) | 48/76 (63%) |
a
Adapted from FDA review (11)
b
Rate of conversion from RBC and/or platelet transfusion dependence (TD) at baseline to RBC and platelet transfusion independence (TI) during any 56-day post-baseline period
c
Number (percentage) of patients who were both RBC and platelet transfusion independent (TI) at baseline and maintained transfusion independence during any 56-day post-baseline period.