OS for subjects in the CHRYSALIS study (ASP2215-CL-0101)
| Molecular response . | Achieved a molecular response . | Did not achieve a molecular response . | P . | ||
|---|---|---|---|---|---|
| n . | Median OS (95% CI), d . | n . | Median OS (95% CI), d . | ||
| ITD VAF ≤10−2 | 20 | 417 (246–NA) | 60 | 199 (142–234) | <.001 |
| ITD VAF ≤10−3 | 18 | 417 (228–NA) | 62 | 213 (143–264) | .003 |
| ITD VAF ≤10−4 (MRD negative) | 13 | 417 (228–NA) | 67 | 213 (144–264) | .002 |
| Molecular response . | Achieved a molecular response . | Did not achieve a molecular response . | P . | ||
|---|---|---|---|---|---|
| n . | Median OS (95% CI), d . | n . | Median OS (95% CI), d . | ||
| ITD VAF ≤10−2 | 20 | 417 (246–NA) | 60 | 199 (142–234) | <.001 |
| ITD VAF ≤10−3 | 18 | 417 (228–NA) | 62 | 213 (143–264) | .003 |
| ITD VAF ≤10−4 (MRD negative) | 13 | 417 (228–NA) | 67 | 213 (144–264) | .002 |
Pre- and posttreatment bone marrow samples were available from 80 patients with FLT3-ITD AML treated with FLT3-inhibitory doses of gilteritinib (ASP2215; 120 or 200 mg/d). A comparison was made between patients achieving a molecular response (FLT3-ITD VAF ≤10−2, ≤10−3, or negative as defined by ITD VAF ≤10−4) by the MRD assay and those not achieving a molecular response by the MRD assay. The P values were determined by the log-rank test.