Multicenter, Open-Label, 3-Arm Study of Gilteritinib, Gilteritinib Plus Azacitidine, or Azacitidine Alone in Newly Diagnosed FLT3 Mutated (FLT3mut+) Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Induction Chemotherapy: Findings from the Safety Cohort

Conclusions: Gilteritinib and AZA were generally well tolerated with no unexpected AEs. This combination therapy induced antileukemic responses in newly diagnosed FLT3mut+ AML pts unfit to receive standard induction chemotherapy. Based on these results, pts are being enrolled into the randomized portion of the study with a dose of 120 mg gilteritinib for the combination treatment arm.DisclosuresWang: Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Jazz: Speakers Bureau; Jazz: Speakers Bureau; Amgen: Consultancy; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Speakers Bureau; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Speakers Bureau; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy. Laribi: Amgen: Other: Personal fees; Takeda: Other: Grant and personal fees; Sandoz: Other: Grant; Novartis: Other: Grant and personal fees; Teva: Other: Grant; Gilead: Other: Personal fees; Hospira: Other: Grant; Roche: Other: Grant. Montesinos: Daiichi Sankyo: Consultancy, Speakers Bureau; Novartis: Research Funding, Speakers Bureau. Liu: Astellas Pharma: Employment. Rich: Astellas Pharma: Employment. Bahceci: Astellas Pharma: Employment.

Source: Blood - November 21, 2018 Category: Hematology Authors: Esteve, J., Schots, R., Bernal Del Castillo, T., Lee, J.-H., Wang, E. S., Dinner, S., Minden, M. D., Salamero, O., Sierra, J., Yoshimoto, G., Laribi, K., Halka, J., Montesinos, P., Liu, S., Rich, E. S., Bahceci, E. Tags: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II Source Type: research