アステラス製薬株式会社(本社:東京、代表取締役社長CEO:安川 健司、以下「アステラス製薬」)は、2021年12月11日から14日にかけて米国ジョージア州アトランタで開催される第63回米国血液学会(American Society of Hematology: ASH)の年次総会において、急性骨髄性白血病(Acute Myeloid Leukemia: AML)および鎌状赤血球症に関する新たなデータを発表します。

 AMLに関する演題には、ギルテリチニブを評価した2つの第III相試験(LACEWING試験、COMMODORE試験)の結果が含まれます。また、AMLの症状、生活への影響、治療に関する患者インタビューと患者報告のアウトカムに基づいた研究も発表予定です。

 鎌状赤血球症に関する演題では、胎児型ヘモグロビンを誘導する可能性のある新規BACH1阻害剤ASP8731の新たな前臨床試験のデータを発表予定です。

 アステラス製薬は、AMLに関する11演題(うち口頭4演題)と、鎌状赤血球症に関する口頭発表1演題の計12演題を発表します。
 

 以下の演題を口頭発表する予定です。

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

 以下の演題をポスター発表する予定です。

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

 以下の演題を資料掲載で発表する予定です。 

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).

以上