Astellas Announces New Data to be Presented at the 2015 ASH Annual Meeting

NORTHBROOK, Ill., Nov. 17, 2015 /PRNewswire/ -- Astellas US, LLC, a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today announced several abstracts, including an oral presentation on gilteritinib (ASP2215), a selective inhibitor of FLT3/AXL, in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML), that will be presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition, Dec. 5-8 in Orlando.

"We are committed to developing treatments for patients in malignant & non-malignant hematology," said Claire Thom, Pharm.D., senior vice president and oncology therapeutic head, Astellas. "Our gilteritinib development program is intended to address the unmet medical needs of AML patients, and we're pleased to present updated results from our Phase 1/2 study focusing initially on individuals with relapsed/refractory FLT3-ITD positive for AML."

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

Title: Antileukemic Activity and Tolerability of ASP2215 80mg and Greater in FLT3 Mutation-Positive Subjects with Relapsed or Refractory Acute Myeloid Leukemia: Results from a Phase 1/2, Open-Label, Dose-Escalation/Dose-Response Study (Altman et al) (Abstract 321)

Presenter: Jessica Altman, M.D., Northwestern University's Feinberg School of Medicine

• Session Date/Time: Sunday, Dec. 6 at 5:00 p.m. EST
• Location: Room W110

Astellas recently announced the dosing of the first patient in a randomized Phase 3 registration trial of gilteritinib versus salvage chemotherapy in patients with R/R AML. On Oct. 27, 2015, the Japanese Ministry of Health, Labor and Welfare (MHLW) announced the selection of gilteritinib as one of the first products designated for SAKIGAKE.

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

• ASP2215 in Japanese Patients with Relapsed or Refractory Acute Myeloid Leukemia: Preliminary Results from a Phase 1 Open-Label, Dose-Escalation Study (Dr. Naoe) (Abstract 1320)
  • Saturday, Dec. 5 from 5:30 p.m. – 7:30 p.m. EST in Hall A, Level 2
• Understanding the Patient's Experience with Acute Myeloid Leukemia: A Patient Interview Study (Dr. van Nooten) (Abstract 2121)
  • Saturday, Dec. 5 from 5:30 p.m. – 7:30 p.m. EST in Hall A, Level 2
• A Phase 1 Study of the Anti-CD37 Antibody-Drug Conjugate AGS67E in Advanced Lymphoid Malignancies. Interim Results (Dr. Sawas) (Abstract 3976)
  • Monday, December 7, 2015, 6:00 p.m. – 8:00 p.m. EST in Hall A, Level 2
• AGS62P1, a Novel Anti-FLT3 Antibody Drug Conjugate, Employing Site Specific Conjugation, Demonstrates Preclinical Anti-Tumor Efficacy in AML Tumor and Patient Derived Xenografts (Dr. Rudra-Ganguly) (Abstract 3806)
  • Monday, December 7, 2015, 6:00 p.m. – 8:00 p.m. EST in Hall A, Level 2

About Acute Myeloid Leukemia
Acute myeloid leukemia is a cancer that impacts the blood and bone marrow and is most commonly experienced in older adults. According to the American Cancer Society, in 2015, there will be an estimated 20,830 new cases of AML diagnosed in the United States, and about 10,460 cases will result in death.

About Astellas
Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information on Astellas, please visit our website at www.astellas.us. You can also follow us on Twitter at @AstellasUS. Visit our Facebook page at www.facebook.com/AstellasUS.

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SOURCE Astellas Pharma Inc.

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