Table 4.
Comparison of gilteritinib Ctrough values at steady state across studies
| Parameter | LACEWING trial | ADMIRAL trial∗ | ||
|---|---|---|---|---|
| Population | ND FLT3mut+ AML ineligible for IIC | R/R FLT3mut+ AML | ||
| Treatment | GIL + AZA and gilteritinib alone | Gilteritinib monotherapy | ||
| Cycle/day | Cycle 1, day 15 | Cycle 2, day 1 | Cycle 1, day 15 | Cycle 2, day 1 |
|---|---|---|---|---|
| No. of values | 82 | 57 | 231 | 219 |
| Median | 584.5 | 583 | 279 | 311 |
| -fold diff pop PK | 2.1 | 2.1 | 1.0 | 1.1 |
| Mean | 698 | 721 | 330 | 372 |
| -fold diff pop PK | 2.1 | 2.2 | 1.0 | 1.1 |
| %CV | 62% | 71% | 68% | 80% |
CV, coefficient of variation; diff, difference; pop, population.
∗
Data not previously presented for ADMIRAL trial.