Emerging mutations in patients with treatment resistance, from Phase 3 ADMIRAL study, will be focus of oral presentation

TOKYO, Dec. 3, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the presentation of new data in acute myeloid leukemia (AML) at the 61st American Society of Hematology (ASH) Annual Meeting, taking place Dec. 7-10 in Orlando, Fla. 

Seven abstracts sponsored by Astellas focus on patients with relapsed (disease that has returned) or refractory (resistant to treatment) AML with a FLT3 mutation (FLT3mut+). The abstracts include new findings from the Phase 3 ADMIRAL trial – an oral presentation on emerging mutations in patients who develop resistance after an initial response to XOSPATA and two poster presentations focused on patient-reported outcomes – as well as data on cost-effectiveness, FLT3 testing and treatment patterns, and venetoclax combination therapy.

“Astellas is committed to elevating care in hard-to-treat cancers, and since the approval of XOSPATA one year ago, we have continued expanding our research program to better understand and address unmet medical needs of patients with FLT3 mutation-positive AML,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. 


Oral Presentation:

Title: Emerging Mutations at Relapse in Patients with FLT3-Mutated Relapsed/ Refractory Acute Myeloid Leukemia Who Received Gilteritinib Therapy in the Phase 3 ADMIRAL Trial (Abstract 14)

Presenter: Catherine C. Smith, M.D., Division of Hematology and Blood and Marrow Transplantation, University of California San Francisco 

  •     Session Date/Time: Saturday, Dec. 7, 7:45 a.m. EST
  •     Location: Orange County Convention Center, W304 Level 3


Key Abstracts Presented During Poster Sessions or Available Online:

Title: The Relationship between Hospitalization and Patient-Reported Outcomes (PROs) in Patients with FLT3-Mutated (FLT3mut+) Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML): Results from the Phase 3 ADMIRAL Study (Abstract 1332)

Lead Author: Ellen K. Ritchie, M.D., Weill Cornell Medicine, New York

  •     Session Date/Time: Saturday, Dec. 7, 5:30-7:30 p.m. EST
  •     Location: Orange County Convention Center, Hall B, Level 2

Title: The Relationship between Transplant Status and Patient-Reported Outcomes in Patients with FLT3-Mutated Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML): Results from the Phase 3 ADMIRAL Study (Abstract 3850)

Lead Author: David Cella, Ph.D., Northwestern University, Feinberg School of Medicine, Chicago

  •     Session Date/Time: Monday, Dec. 9, 6-8 p.m. EST
  •     Location: Orange County Convention Center, Hall B, Level 2

Title: Cost-Effectiveness Analysis of Gilteritinib Versus Salvage Chemotherapy (SC) for the Treatment of Relapsed or Refractory (R/R) FLT3-Mutated (FLT3mut+) Acute Myeloid Leukemia (AML) (Abstract 3859)

Lead Author: Amer M. Zeidan, MBBS, MHS, Department of Internal Medicine, Section of Hematology, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.

  •     Session Date/Time: Monday, Dec. 9, 6-8 p.m. EST
  •     Location: Orange County Convention Center, Hall B, Level 2 

Title: Venetoclax in Combination with Gilteritinib in Patients with Relapsed/Refractory Acute Myeloid Leukemia: A Phase 1b Study (Abstract 3910) (Supported by AbbVie, Astellas and Genentech)

Lead Author: Alexander E. Perl, M.D., Abramson Cancer Center of the University of Pennsylvania, Philadelphia.

  •     Session Date/Time: Monday, Dec. 9, 6-8 p.m. EST 
  •     Location: Orange County Convention Center, Hall B, Level 2

Title: STREAMLINE - Study of Relapse or Refractory (R/R) FLT3-Mutated Acute Myeloid Leukemia (AML) Using Electronic Medical Records (EMR): First Analysis from a Multicenter, Retrospective Cohort Study (Abstract 5082)

Lead Author: Amer M. Zeidan, MBBS, MHS, Department of Internal Medicine, Section of Hematology, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.

Title: Cost-Effectiveness Analysis of Gilteritinib Versus Best Supportive Care (BSC) for the Treatment of Relapsed or Refractory (R/R) FLT3 Mutation-Positive (FLT3mut+) Acute Myeloid Leukemia (AML) (Abstract 5085)

Lead Author: Amer M. Zeidan, MBBS, MHS, Department of Internal Medicine, Section of Hematology, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.


Astellas-Supported Satellite Symposia 
Astellas will support the following pre-meeting Friday Satellite Symposia

Title: Data + Perspectives: Exploring the Role of Novel Agents and Emerging Strategies in the Management of Acute Myeloid Leukemia  

  •     Session Date/Time: Friday, Dec. 6, 7-11 a.m. EST
  •     Location: Hilton Orlando, Orange Ballroom (Lower Level)

Title: Treating Acute Myeloid Leukemia: Case Challenges and Emerging Therapies 

  •     Session Date/Time: Friday, Dec. 6, 6-10 p.m. EST
  •     Location: Hyatt Regency Orlando, Plaza International D-F 

 

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