Astellas Pharma : to Present Research on FLT3 Mutation-Positive Acute Myeloid Leukemia – from Diagnosis to Relapse – at 2021 American Society of Hematology Annual Meeting

• Four AML oral presentations are among highest number of Astellas-sponsored ASH abstracts to date
• Full results of Phase 3 LACEWING, COMMODORE trials will be presented
• Oral presentation explores potential sickle cell disease treatment pathway

TOKYO, Dec. 1, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the presentation of new investigational data in acute myeloid leukemia (AML) and sickle cell disease at the 63^rd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 11-14, in Atlanta, Ga. Astellas' largest ASH showing to date includes 11 AML abstracts, including four oral presentations.

"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 China, Malaysia, Thailand, Singapore, and Russia.

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 Erhan Berrak, M.D., Vice President of Medical Affairs, Oncology, Astellas. "For example, one study to be presented at this year's ASH meeting investigated the patient experience after a stem-cell transplant, shedding light on both symptoms and emotional impact, which can inform efforts to better serve patients post-transplant."

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 Itsuro Nagase, Ph.D., D.V.M., Vice President and Primary Focus Lead, Mitochondrial Biology, Astellas. "These data further support our focus on mitochondrial disease research and the advances we are making across the Astellas research pipeline to develop novel therapies for patients with unmet medical needs."

Oral Presentations

Title:Symptoms and Impacts Reported by Patients with Acute Myeloid Leukemia (AML) in Remission Post-Stem Cell Transplant (Abstract 278).

• Presenting author: Thomas Leblanc, M.D., M.A., Department of Medicine, Duke University School of Medicine, Durham, N.C., USA
• Session Date/Time: Saturday, Dec. 11, 2:15 p.m. ET

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).

• Presenting author: Eunice S. Wang, M.D., Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., USA
• Session Date/Time: Monday, Dec. 13, 3:30 p.m. ET

Title:Gilteritinib Versus Salvage Chemotherapy for Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia: A Phase 3, Randomized, Multicenter, Open-Label Trial in Asia (COMMODORE) (Abstract 695).

• Presenting author: Jianxiang Wang, M.D., State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China
• Session Date/Time: Monday, Dec. 13, 3:45 p.m. ET

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 Genentech) (Abstract 691).

• Presenting author: Naval Daver, M.D., Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
• Session Date/Time: Monday, Dec. 13, 2:45 p.m. ET

Title:ML-0207/ASP8731: A Novel BACH1 Inhibitor That Induces Fetal Hemoglobin in Treatment of Sickle Cell Disease (Abstract 854).

• Presenting author: Greg Vercellotti, MD, Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, Minn., USA
• Session Date/Time: Monday, Dec. 13, 6:30 p.m. ET

Poster Presentations

Title:A Phase 1, Dose-Escalation Study of Gilteritinib Combined with Chemotherapy in Patients Aged 6 Months to <21 Years with FLT3 Internal Tandem Duplication-Positive Relapsed or Refractory AML (Abstract 2315).

• Presenting author: Philip Connor, M.B.B.S., Department of Pediatric Hematology/Oncology, Noah's Ark Children's Hospital for Wales, Cardiff, Wales, UK
• Session Date/Time: Sunday, Dec. 12, 6-8 p.m. ET

Title:Impact of FLT3 Mutation Clearance After Front-Line Treatment with Gilteritinib Plus Azacitidine, or Gilteritinib or Azacitidine Alone in Patients with Newly Diagnosed Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy: Results from the Phase 3 LACEWING Trial (Abstract 3445).

• Presenting author: Eunice S. Wang, M.D., Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., USA
• Session Date/Time: Monday, Dec. 13, 6-8 p.m. ET

Title:Patient Reported Outcomes in Patients with Newly Diagnosed FLT3mut+ Acute Myeloid Leukemia Ineligible for Intensive Induction Chemotherapy From LACEWING: A Randomized Phase 3 Trial of Gilteritinib and Azacitidine Versus Azacitidine Alone (Abstract 3058).

• Presenting author: Eunice S. Wang, M.D., Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., USA
• Session Date/Time: Sunday, Dec. 12, 6-8 p.m. ET

Title:First Salvage Therapy for Relapsed or Refractory Acute Myeloid Leukemia: Associated Health Care Resource Use and Costs (Abstract 1936).

• Presenting author: Lori Muffly, M.D., M.S., Division of Blood and Marrow Transplantation, Stanford University, Stanford, Calif., USA
• Session Date/Time: Saturday, Dec. 11, 5:30-7:30 p.m. ET

Title:Gilteritinib Can Be Safely Combined with Atezolizumab for The Treatment of Relapsed or Refractory FLT3-Mutated AML: Results of a Phase 1 Study (Abstract 2343).

• Presenting author: Jessica K. Altman, M.D., Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Feinberg School of Medicine, Chicago, Ill., USA
• Session Date/Time: Sunday, Dec. 12, 6-8 p.m. ET

Title:Patient and Physician Preferences for Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) in Patients Not Candidates for Intensive Chemotherapy (Abstract 4047).

• Presenting author: Mo Zhou, Ph.D., Analysis Group, Boston, Mass., USA
• Session Date/Time: Monday, Dec. 13, 6-8 p.m. ET

Online-Only Publication

Title: Real-World Use of FLT3 Tyrosine Kinase Inhibitors in Patients with Relapsed/Refractory FLT3 Mutation-Positive Acute Myeloid Leukemia in the United States (Abstract 5033).

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