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Therapeutic efficacy of Gilteritinib

The efficacy of Gilteritinib was assessed in the ADMIRAL Trial (NCT02421939), which included adult patients with  relapsed or refractory AML having a FLT3 ITD, D835, or I836 mutation by the LeukoStrat® CDx FLT3 Mutation Assay.  Gilteritinib was given orally at a starting dose of 120 mg daily until unacceptable toxicity or lack of clinical benefit.

First Interim Analysis  

The efficacy of Gilteritinib was established on the basis of the rate of complete remission (CR)/CR with partial  hematological recovery (CRh), the duration of CR/CRh (DOR), and the rate of conversion from transfusion dependence to  transfusion independence at the first interim analysis in the ADMIRAL trial (n=138). The median follow-up was  4.6 months (95% CI: 2.8, 15.8). Fourteen patients were still in remission at the time of the first interim DOR analysis. The  efficacy results are shown in Table 5. For patients who achieved a CR/CRh, the median time to first response was  3.6 months (range, 0.9 to 9.6 months). The CR/CRh rate was 29 of 126 in patients with FLT3-ITD or FLT3-ITD/TKD and  0 of 12 in patients with FLT3-TKD only.

Among the 106 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 33 (31.1%)  became independent of RBC and platelet transfusions during any 56-day post-baseline period. For the 32 patients who  were independent of both RBC and platelet transfusions at baseline, 17 (53.1%) remained transfusion-independent during  any 56-day post-baseline period.

Final Analysis 

The final analysis of the ADMIRAL trial included 371 adult patients randomized 2:1 to receive Gilteritinib 120 mg once  daily (n=247) over continuous 28-day cycles or a prespecified chemotherapy regimen (n=124). Randomization was stratified by response to first-line AML therapy and prespecified chemotherapy. The prespecified chemotherapy regimens  included high intensity combinations (MEC and FLAG-IDA) and low intensity regimens (LDAC and AZA).

FDA,2022.01