'Research being presented at this year's ASH meeting investigates gilteritinib across the FLT3-mutation-positive AML disease continuum,' said Ahsan Arozullah, M.D., M.P.H., Vice President, Medical Sciences-Oncology, Astellas. 'Several presentations highlight data for gilteritinib in a wide range of patients - from newly diagnosed to relapsed or refractory patients, and in varying combination regimens.'
Presentations will include results from two Phase 3 trials: three abstracts from LACEWING, a clinical trial which included patients with newly diagnosed FLT3 mutation-positive (FLT3mut+) AML who were ineligible for first-line intensive induction chemotherapy; and one from COMMODORE, a trial of gilteritinib versus salvage chemotherapy in patients with FLT3mut+ relapsed or refractory AML conducted in
Astellas will also present research based on patients' perspectives of AML symptoms, life impact and treatment. 'A deeper understanding of patient experiences is vital as we seek better treatment approaches in all stages of AML,' said
In addition, Astellas plans to present new preclinical data on sickle cell disease (SCD) for ASP8731, a novel BACH1 inhibitor that potentially induces fetal hemoglobin (HbF). The data show potential to increase expression of antioxidant and HbF genes and reduce SCD-related pathophysiology. This may result in the reduction of hemolysis, inflammation, and vaso-occlusive pain crises in patients living with the condition.
'We are pleased to have the opportunity to present our preclinical data supporting further development of ASP8731, our BACH1 inhibitor,' said
Oral Presentations
Title: Symptoms and Impacts Reported by Patients with Acute Myeloid Leukemia (AML) in Remission Post-Stem Cell Transplant (Abstract 278).
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Title: Phase 3, Open-Label, Randomized Study of Gilteritinib and Azacitidine vs Azacitidine for Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia in Patients Ineligible for Intensive Induction Chemotherapy (LACEWING) (Abstract 700).
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Title: Gilteritinib Versus Salvage Chemotherapy for Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia: A Phase 3, Randomized, Multicenter, Open-Label Trial in
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Title: Venetoclax in Combination with Gilteritinib Demonstrates Molecular Clearance of FLT3 Mutation in Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia (Supported by AbbVie, Astellas and
Presenting author: Naval Daver, M.D.,
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Title: ML-0207/ASP8731: A Novel BACH1 Inhibitor That Induces Fetal Hemoglobin in Treatment of Sickle Cell Disease (Abstract 854).
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Poster Presentations
Title: A Phase 1, Dose-Escalation Study of Gilteritinib Combined with Chemotherapy in Patients Aged 6 Months to
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