On November 16, 2020 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported the presentation of new data in acute myeloid leukemia (AML) at the virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 5-8, 2020 (Press release, Astellas, NOV 16, 2020, View Source [SID1234571060]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Nine Astellas-sponsored abstracts focused on patients with AML with a positive FLT3 mutation (FLT3mut+) are being presented, comprising five oral presentations, three posters and one online-only presentation. Oral presentations include new data on the use of gilteritinib, either as monotherapy or in combination, across the FLT3mut+ AML patient spectrum – from those newly diagnosed, to relapsed or refractory patients who have been pre-treated with other tyrosine kinase inhibitors (TKIs) – as well as a secondary analysis of the Phase 3 ADMIRAL trial.

"The research being presented at ASH (Free ASH Whitepaper) will shed light on critical unmet needs and continuing progress against AML, which remains a hard-to-treat cancer in spite of continuing medical advances," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. "Several presentations will describe the effects of gilteritinib in a wide range of AML patients with a positive FLT3 mutation. We also look forward to discussing our Phase 3 LACEWING trial in progress, as well as findings from the STREAMLINE study related to real-world FLT3 testing rates in AML patients, both upon diagnosis and after relapse."

Gilteritinib is approved as XOSPATA in the U.S. and selected other countries for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.

Oral Presentations

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 FLT3 Mutated 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
Poster Presentations
Poster presentations are available online from Saturday, Dec. 5, 7 a.m. PST to Monday, Dec. 7, 3:30 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
Online-Only Presentation

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

Astellas-Supported Satellite Symposium
Astellas will support the following pre-meeting Friday Satellite Symposia Live Webinar.

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, 3-6 p.m. PST