A phase I/II study of gilteritinib in combination with chemotherapy in newly diagnosed patients with AML in Asia: final analysis - PubMed
4 hours ago
- #AML
- #gilteritinib
- #FLT3 mutations
- Phase I/II study evaluated gilteritinib combined with chemotherapy in newly diagnosed Asian AML patients with FLT3 mutations.
- Gilteritinib is a selective oral FLT3 inhibitor, showing promise for FLT3-mutated AML patients.
- Study included 84 patients across Japan, Korea, and Taiwan, treated with induction, consolidation, and maintenance therapy.
- Primary efficacy endpoint was complete remission (CR) rate after induction, achieved at 50.0%.
- Composite CR (CRc) rate after induction was 86.6%, indicating high efficacy.
- 3-year overall survival (OS) rate was 71.6%, with median OS of 48.2 months (data still immature).
- 51.2% of patients underwent hematopoietic stem cell transplantation during the study.
- Safety profile of gilteritinib was as expected, with no new safety signals identified.
- Therapy was well-tolerated and showed favorable efficacy compared to historical data.