Navigation Links
Astellas Announces Updated Data from the Phase 1/2 CHRYSALIS Trial for Gilteritinib (ASP2215) in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Date:12/6/2015

NORTHBROOK, Ill., Dec. 6, 2015 /PRNewswire/ -- Astellas US, LLC, a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today announced that updated data from the Phase 1/2 CHRYSALIS trial evaluating the safety, tolerability and  antileukemic activity of gilteritinib (ASP2215), an orally-administered inhibitor of FLT3/AXL in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML), were presented during an oral scientific session at the American Society of Hematology (ASH) 2015 annual meeting in Orlando.

Gilteritinib has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in up to one-third of patients with AML.

This updated analysis of the Phase 1/2 study included 169 patients with FLT3 mutations who were treated with  at least 80 mg gilteritinib. A 53% overall response rate (ORR) was demonstrated  regardless of prior therapy. Additionally, a 56% ORR was observed in patients who had a FLT3-ITD mutation, and 48% ORR was observed in patients who were treated with TKI prior to the study. Median overall survival was approximately 31 weeks (95% CI: 24–35). Treatment-related adverse events (AE) reported in >10% of the safety population included diarrhea (16%), fatigue (13%), AST increase (12%). Grade >3 QTc prolongation was reported in 3% of subjects.

"We are pleased to see that gilteritinib demonstrates antileukemic activity even in patients whose mutations have previously been associated with poor outcomes," said Trial Investigator  Jessica Altman, M.D. and associate professor of Hematology/Oncology at Northwestern University's Feinberg School of Medicine.

"We live in an era of personalized medicine and targeted therapies, yet there is still a significant need for more effective AML treatments, particularly for patients with well-characterized FLT3 molecular defects." said Erkut Bahceci, M.D. and executive medical director, Astellas. "Targeting both FLT3-ITD and FLT3-TKD mutations, as well as AXL, can potentially help avoid the acquired resistance seen with existing FLT3-ITD inhibitors and may  increase duration of therapy."

Recently, Astellas announced the dosing of the first patient in the ADMIRAL trial, a randomized Phase 3 registrational study of gilteritinib versus salvage chemotherapy in patients with R/R AML.The primary endpoint of the trial is overall survival. More information about this trial can be found at www.clinicaltrials.gov, trial identifier NCT02421939.

About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) 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.

Logo - http://photos.prnewswire.com/prnh/20140416/84970


'/>"/>
SOURCE Astellas Pharma US, Inc.
Copyright©2015 PR Newswire.
All rights reserved


Related medicine technology :

1. Biovista Inc. Announces Drug Repositioning Collaboration with Astellas Pharma
2. Biovista Inc. gibt Zusammenarbeit mit Astellas Pharma zwecks Umpositionierung von Arzneimitteln bekannt
3. Astellas appoints Peter Sandor to Vice President, Oncology Therapeutic Area Head for Marketing Strategy
4. Astellas to Acquire Ocata Therapeutics
5. Astellas Promotes Doug Geiger to Vice President, Head of New Therapeutic Areas in Marketing Strategy
6. Astellas and Chromocell Announce License and Collaboration Agreement to Develop and Commercialize New Therapies to Treat Neuropathic Pain
7. Astellas European Foundation gewährt Zuschüsse zur Untersuchung neuartiger molekularer Bildgebungstechniken für Patienten mit Prostatakrebs
8. Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections
9. Julie Monzo Joins Astellas Corporate Affairs
10. Astellas And Medivation Announce Enrollment Of The First Patients In Advanced Prostate Cancer Outcomes Registry
11. Astellas and The Chris Klug Foundation Announce Winners of the 2015 Bounce Back Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/17/2019)... ... July 17, 2019 , ... Highmark Health, Allegheny Health ... enthusiasts from around the region to announce plans for what will be one of ... in Coraopolis on State Avenue and adjacent to the Montour Trail, the complex is ...
(Date:7/17/2019)... ... ... The American Psychiatric Nurses Association (APNA) is pleased to announce the ... by psychiatric-mental health nurse members from across the country, these six individuals will begin ... October 2-5, 2019. , “These new members of the Board of Directors and Nominating ...
(Date:7/17/2019)... ... July 17, 2019 , ... Halcyon, one of ... its payment processor of record. , As a result of the partnership, ... platform can now also accept and process payments through it, securely and easily. ...
Breaking Medicine Technology:
(Date:7/18/2019)... ... July 18, 2019 , ... We are pleased ... Texas Monthly Super Doctor Rising Star ! Each year, Texas Monthly ... trust for their own medical care. The Super Doctors research team then investigates ...
(Date:7/17/2019)... ... July 17, 2019 , ... The FDA has cleared the ... treating up to eight body areas simultaneously. Dr. Dennis Dass says the ... and easier than previous muscle toning devices or conventional exercise. , “The truSculpt® flex ...
(Date:7/17/2019)... (PRWEB) , ... July 17, 2019 , ... In order ... which damage to the teeth could occur, from the accident scene, to the moment ... and created a paradigm shift for treatment. , They identified seven points, so called ...
(Date:7/17/2019)... ... 2019 , ... Dynamic Healthcare Systems, a leading ... Marketplace programs is pleased to announce the introduction of an expanded Risk ... at the point of care to providers and provider groups participating in value-based ...
(Date:7/17/2019)... ... July 17, 2019 , ... It took just several ... Carlos Martinez, MD, to relieve pressure on the nerves under Amber Walck’s scalp, and ... PA woman turned 30 last year, her debilitating headaches began without warning. About ...
Breaking Medicine News(10 mins):