Quizartinib (AC220) in Patients With FLT3-ITD(+) Relapsed or Refractory Acute Myeloid Leukemia: Final Results of a Randomized Phase 2 Study

Background

FLT3-ITD in AML is associated with early relapse and poor survival after treatment with standard chemotherapy

Quizartinib is an orally active FLT3-ITD inhibitor
A previous Phase 2 study included subjects with FLT3-ITD(+) AML, relapsed/refractory to 2nd line chemotherapy or relapsed after hematopoietic stem cell transplant (HSCT), doses of 90, 135 or 200 mg/day
– 46% of subjects achieved CRc (CRc = CR + CRp + CRi)
– 35% of subjects were bridged to HSCT (mostly after achieving CRi)
– 33% of subjects with a CRi and bridged to HSCT were alive beyond 1 year
– Quizartinib was generally well tolerated
Grade 3 QTcF was observed in 18% of subjects
No Grade 4 QTcF prolongation was recorded