Business Wire

Astellas Announces Updated Data from the Phase 1/2 CHRYSALIS Trial for Gilteritinib (ASP2215) in Patients with Relapsed or Refractory Acute Myeloid Leukaemia

Del

Astellas Pharma Europe today announced that updated data from the Phase 1/2 CHRYSALIS trial, evaluating the safety, tolerability and efficacy of gilteritinib (ASP2215), an orally-administered inhibitor of FLT3/AXL in patients with relapsed or refractory (R/R) acute myeloid leukaemia (AML), were presented during an oral scientific session at the American Society of Hematology (ASH) 2015 annual meeting in Orlando.1 Preliminary data were presented at the 20th Congress of the European Hematology Association in June 2015 in Vienna, Austria.2

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.1

This updated analysis of the Phase 1/2 study included 169 patients with FLT3 mutations who were treated with ≥80 mg and more (up to 450 mg) of 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 a tyrosine kinase inhibitor (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 diarrhoea (16%), fatigue (13%), and aspartate aminotransferase (AST) increase (12%). Grade ≥3 QTc prolongation was reported in 3%. Serious adverse events that occurred in ≥10% of total subjects were febrile neutropenia (n=77; 31%), disease progression (n=32; 13%), and sepsis (n=30; 12%).1

“Long-term survival outcomes for patients of any age with acute myeloid leukemia (AML) using current treatments offer substantial room for improvement, and for patients with a mutation of the FLT3 gene, the need is even greater,” said Bob Löwenberg, M.D., professor of Hematology at Erasmus University Medical Center in Rotterdam Netherlands. “Promising therapies personalised to target specific biomarkers and with innovative mechanisms of action, such as gilteritinib, could change the outlook and prognosis for these patients.”

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

“We live in an era of personalised medicine and targeted therapies, yet there is still a significant need for more effective AML treatments, particularly for patients with well-characterised 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.”

Notes to editors

About Acute Myeloid Leukaemia
Acute myeloid leukemia is a cancer that affects white blood cells and bone marrow.3 AML usually develops quickly, over days or weeks.3 It is most often diagnosed in older people, and is most common in people over 65 years old.3 The incidence of AML in European adults is 5-8 cases per 100,000.4 About two out of three AML patients who get standard induction chemotherapy with daunorubicin and cytarabine go into remission.5 The chance of remission depends to a large part on a person’s specific prognostic factors, such as age or the presence of certain gene or chromosome changes.5 Currently, available treatment options for R/R AML patients with FLT3 mutations are limited and prognosis is poor.6

About Astellas
Astellas Pharma Europe Ltd. operates in 40 countries across Europe, the Middle East and Africa, and is the regional business of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation’s focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas’ presence in Europe also includes an R&D site and three manufacturing plants. The company employs approximately 4,350 staff across these countries.

References

  1. Jessica K. Altman, Alexander E. Perl, Jorge Cortes et. al., Antileukemic Activity and Tolerability of ASP2215 ≥80 mg 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 presented during an oral scientific session at the American Society of Hematology (ASH) 2015 annual meeting in Orlando, 6 Dec 2015
  2. Perl A, Altman J, Cortes J, et al. Results of a first in-human, Phase 1/2 trial of ASP2215, a selective, potent oral inhibitor of FLT3/AXL, in patients with relapsed or refractory acute myeloid leukaemia. 20th Congress of the European Hematology Association, Vienna, Austria. Presentation [Abstract No. S798]
  3. Cancer Research UK. The blood and acute myeloid leukaemia. Available at: http://www.cancerresearchuk.org/about-cancer/type/aml/about/the-blood-and-acute-myeloid-leukaemia (Last accessed June 2015)
  4. Patient UK. Acute Myeloid Leukaemia factsheet. Available at http://www.patient.co.uk/doctor/acute-myeloid-leukaemia-pro (Last accessed June 2015)
  5. American Cancer Society. Treatment response rates for acute myeloid leukemia. Available at: http://www.cancer.org/cancer/leukemia-acutemyeloidaml/detailedguide/leukemia--acute-myeloid--myelogenous--treating-response-rates. (Last accessed June 2015)
  6. Grunwald MR, Levis MJ. FLT3 inhibitors for acute myeloid leukemia: a review of their efficacy and mechanisms of resistance. Int J Hematol 2013; 97(6):683-94

Contact information

Astellas Contacts:
Emma White, +44 (0)7786 312623
Manager, Communications, EMEA
or
Red Door Unlimited
Laura Good, +44 (0)7889 757191

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201720.10.2017 21:00Pressemelding

Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are

More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 15:08Pressemelding

The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable

Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 12:15Pressemelding

Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside

Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 12:03Pressemelding

Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f

SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 10:47Pressemelding

SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom