Astellas Announces Updated Data from the Phase 1/2 CHRYSALIS Trial for Gilteritinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia

Astellas US, LLC, a subsidiary of Tokyo-based Astellas Pharma Inc.

, today announced that updated data from the Phase 1/2 CHRYSALIS trial evaluating the safety, tolerability and  antileukemic activity of gilteritinib (ASP2215), an orally-administered inhibitor of FLT3/AXL in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML), were presented during an oral scientific session at the American Society of Hematology (ASH) 2015 annual meeting in Orlando. Gilteritinib has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in up to one-third of patients with AML. This updated analysis of the Phase 1/2 study included 169 patients with FLT3 mutations who were treated with  at least 80 mg gilteritinib. A 53% overall response rate (ORR) was demonstrated  regardless of prior therapy. Additionally, a