- Abstracts include updated results from Phase 1 study of gilteritinib in patients with newly diagnosed AML -

TOKYO – November 19, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced it will present new data in Acute Myeloid Leukemia (AML) research at the 60th American Society of Hematology (ASH) Annual Meeting, taking place December 1-4, 2018 in San Diego, California. Among the data being presented are updated results from a Phase 1 study of gilteritinib in combination with induction and consolidation chemotherapy in patients with newly diagnosed AML.

At ASH, collaborating researchers from renowned academic medical centers will present data exploring the use of gilteritinib to treat patients across the FLT3 mutation-positive (FLT3mut+) AML care continuum—from newly diagnosed to relapsed or refractory patients—and on healthcare resource utilization in the current treatment of FLT3mut+ AML. Additionally, Astellas will sponsor two sessions in ASH’s Friday Satellite Symposia program prior to the meeting. 

“Patients with this life-threatening disease have long had limited treatment options. Developing new therapies that help address unmet medical needs and provide physicians with new tools to treat patients in multiple stages of the FLT3mut+ AML journey is our priority,” said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. “We’re pleased to present new data at ASH examining the potential for gilteritinib to treat diverse groups of FLT3mut+ AML patients, and to share research on healthcare resource utilization among this patient population.”

The following abstract will be presented during an oral presentation session:

Title: Updated Results From a Phase 1 Study of Gilteritinib in Combination With Induction and Consolidation Chemotherapy in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) (Abstract 564)

Presenter: Keith W. Pratz, M.D., John Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

  • Session Date/Time: Monday, December 3, 8:15 a.m. PST
  • Location: Manchester Grand Hyatt, Seaport Ballroom F

In addition to the oral presentation, Astellas will present the following abstracts during poster sessions:

Title: Impact of Minimal Residual Disease and Achievement of Complete Remission/Complete Remission With Partial Hematologic Recovery (CR/CRh) on Overall Survival Following Treatment With Gilteritinib in Patients With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) With FLT3 Mutations (Abstract 1458)

Lead Author: Mark J. Levis, M.D., Ph.D., John Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

  • Session Date/Time: Saturday, December 1, 6:15 p.m. PST
  • Location: San Diego Convention Center, Hall GH

Title: Multicenter, Open-Label, 3-Arm 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: Findings From the Safety Cohort (Abstract 2376)

Lead Author: Jordi Esteve, M.D. Ph.D., Hospital Clínic de Barcelona, Barcelona, Spain

  • Session Date/Time: Sunday, December 2, 6:00 p.m. PST
  • Location: San Diego Convention Center, Hall GH

Title: Treatment Patterns and Healthcare Resource Utilization (HRU) in Patients With Relapsed/Refractory (R/R) FLT3-Mutated (FLT3mut) and FLT3-Wild Type (FLT3wt) Acute Myeloid Leukemia (AML): A Multi-Country Medical Chart Study (Abstract 4824)

Presenter: James D. Griffin, M.D., Dana-Farber Cancer Institute, Boston 

  • Session Date/Time: Monday, December 3, 6:00 p.m. PST
  • Location: San Diego Convention Center, Hall GH

Astellas will sponsor the following symposia during the pre-meeting Friday Satellite Symposia (FSS):

Title: Moving Toward Precision Therapy for Patients with AML: Clinical Challenges and Future Directions  

  • Session Date/Time: Friday, November 30, 12:30 p.m. PST
  • Location: Marriott, San Diego Ballroom 

Title: Novel Therapies for AML: Expanding Future Options

  • Session Date/Time: Friday, November 30, 12:30 p.m. PST
  • Location: San Diego Convention Center, Room 1AB