ニュース

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、2020年12月5日から8日にかけてオンラインで開催される第62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）に関する新たなデータを発表します。

　アステラス製薬は、FLT3遺伝子変異陽性AML患者を対象とした、5つの口頭発表、3つのポスター発表、1つの資料掲載の計9演題を発表します。口頭発表では、新たにAMLと診断された患者から、他のチロシンキナーゼ阻害剤（TKIs）による治療後に再発もしくは難治性の患者までの、幅広いFLT3遺伝子変異陽性AML患者に対し、第III相ADMIRAL試験の二次解析に加えて、ギルテリチニブを単剤または併用療法として投与した際の新たな成績を報告する予定です。

　AMLは依然として治療することが難しく、アンメットメディカルニーズの高いがんです。アステラス製薬は、ASHで発表されるギルテリチニブの研究成果が、AML治療の新たな進歩へとつながるよう、引き続き取り組んでまいります。

　以下の演題が口頭発表される予定です。

Title: A Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed AML: Final Results (Abstract 24)

• Presenting author: Dr. Keith W. Pratz, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore
• Session Date/Time: Saturday, Dec. 5, 7:30 a.m. PST

Title: Phase 3, Multicenter, Open-Label 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 (Trial in progress) (Abstract 27)

• Presenting author: Dr. Eunice S. Wang, Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y.
• Session Date/Time: Saturday, Dec. 5, 8:15 a.m. PST

Title: Comparison of Gilteritinib and Salvage Chemotherapy in FLT3-Mutated Acute Myeloid Leukemia on the Number Needed to Treat for Various Clinical Outcomes: A Secondary Analysis of the Admiral Trial (Abstract 213)

• Presenting author: Amer M. Zeidan, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.
• Session Date/Time: Saturday, Dec. 5, noon PST

Title: Efficacy and Safety of Venetoclax in Combination with Gilteritinib for Relapsed/Refractory FLT3Mutated Acute Myeloid Leukemia in the Expansion Cohort of a Phase 1b Study (Abstract 333) (Supported by AbbVie, Astellas and Genentech)

• Presenting author: Dr. Naval G. Daver, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston
• Session Date/Time: Sunday, Dec. 6, 10:15 a.m. PST

Title: Clinical Outcomes in Patients with Relapsed/Refractory Acute Myeloid Leukemia Treated with Gilteritinib Who Received Prior Midostaurin or Sorafenib (Abstract 334)

• Presenting author: Dr. Alexander E. Perl, Abramson Cancer Center, University of Pennsylvania, Philadelphia
• Session Date/Time: Sunday, Dec. 6, 10:30 a.m. PST

　以下の演題がポスター発表される予定です。

Poster presentations are available online from Saturday, Dec. 5, 7 a.m. PST to Monday, Dec. 7, 3 p.m. PST.

Title: STREAMLINE – Retrospective Cohort Study of Relapsed or Refractory (R/R) FLT3-Mutated Acute Myeloid Leukemia (AML): Real-World Treatment, Testing Patterns, and Outcomes (Abstract 2826)

• Presenting author: Dr. Amer M. Zeidan, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.

Title: Clinical Outcomes Following Treatment with Gilteritinib or Quizartinib in Patients with Relapsed/Refractory FLT3-ITD+ Acute Myeloid Leukemia (Abstract 995)

• Presenting author: Dr. Alexander E. Perl, Abramson Cancer Center, University of Pennsylvania, Philadelphia

Title: Pain and Opioid Use in Patients with FLT3 Mutation-Positive Relapsed/Refractory AML: A Subanalysis of Patient-Reported Outcomes from the ADMIRAL Trial (Abstract 2568)

• Presenting author: Manasee V. Shah, Global Health Economics and Outcomes Research, Astellas 

　以下の演題の発表資料が掲載される予定です。

Title: Real-World Use of FLT3-TKIs in R/R FLT3-Mutated AML in the United States (Abstract 4413)

　また、上記の発表に加え、ASHの前日に開催されるFriday Satellite Symposia において、アステラス製薬は以下のLive Webinarを共催します。

Title: Consensus or Controversy? Investigators Discuss Clinical Practice Patterns and Available Research Data Guiding the Management of Acute Myeloid Leukemia (Part 3 of a 4-part Series)

• Session Date/Time: Friday, Dec. 4, 3-4 p.m. PST

以上