Daiichi Sankyo Data at ASH Showcases Scientific and Clinical Advancements Across AML/Blood Cancer Portfolio
6.11.2019 17:00:00 EET | Business Wire | Press release
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it will present new data for several investigational therapies in its AML/blood cancer portfolio at the 61st Annual Meeting of the American Society of Hematology (ASH), December 7-10, 2019, in Orlando, Florida.
Highlights include three oral presentations featuring post-hoc analyses from the global, pivotal phase 3 QuANTUM-R study including post-transplant survival, genetic/biomarker-related responses and outcomes, and quality-adjusted time without symptoms or toxicity in patients with relapsed/refractory FLT3-ITD AML receiving quizartinib versus salvage chemotherapy.
“The additional findings from the phase 3 study will help inform clinical use as well as further development of quizartinib, which is currently being evaluated in newly-diagnosed FLT3-ITD AML in the QuANTUM-First trial,” said Arnaud Lesegretain, Vice President, Oncology Research and Development and Head, AML Franchise, Daiichi Sankyo. “Other ASH presentations reflect clinical development progress for several of our investigational therapies, including valemetostat, which is an important asset in our R&D program for patients with AML and other blood cancers.”
Updated phase 1 study results will be reported for valemetostat, a potential first-in-class EZH1/2 dual inhibitor, in relapsed/refractory non-Hodgkin lymphomas (NHLs), including a subgroup analysis in patients with adult T-cell leukemia/lymphoma (ATL/L). A pivotal phase 2 study in patients with ATL/L is planned in Japan.
Following is a full list of abstracts from the Daiichi Sankyo oncology portfolio accepted at ASH:
|
ASH Abstract Title |
Presentation Details |
|
Quizartinib / QuANTUM-R |
|
|
Clinical Outcomes and Characteristics of Patients with FLT3-ITD-Mutated Relapsed/Refractory (R/R) AML Undergoing Hematopoietic Stem Cell Transplantation (HSCT) after Quizartinib or Salvage Chemotherapy in the QuANTUM-R Trial |
Abstract #736; Oral Presentation (Ganguly S)
|
|
Effect of Co-Mutations and FLT3-ITD Variant Allele Frequency (VAF) on Response to Quizartinib or Salvage Chemotherapy (SC) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) |
Abstract #737; Oral Presentation (Perl A)
|
|
Quality-Adjusted Time without Symptoms or Toxicity (Q-TWiST) Analysis of Quizartinib Vs. Salvage Chemotherapy in Patients with Relapsed/Refractory (R/R) FLT3-ITD AML |
Abstract #382; Oral Presentation (Cortes J)
|
|
Pooled Safety Analysis of Quizartinib Monotherapy in Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) |
Abstract #1372; Poster Presentation (Cortes J)
|
|
Characterization of Response and Transfusion Independence in Patients with FLT3-ITD-Mutated Relapsed/Refractory AML Treated with Quizartinib or Salvage Chemotherapy in the QuANTUM-R Trial |
Abstract #2599; Poster Presentation (Levis M)
|
|
Exposure-Response of Quizartinib Efficacy in Patients with Relapsed/Refractory AML |
Abstract #1263; Poster Presentation (Kang D)
|
|
A Phase 1/2 Study of Quizartinib (Q) in Combination with Re-Induction Chemotherapy and As Single-Agent Continuation Therapy in Pediatric and Young Adult Patients with Relapsed/Refractory (R/R) FLT3-ITD AML |
Abstract #3937; Poster Presentation (Zwaan M)
|
|
An Evaluation of Major Comorbidities and Treatment Patterns of Newly Diagnosed Acute Myeloid Leukemia Patients: A Retrospective Analysis of Electronic Medical Records from US |
Abstract #5106; Publication Only (Tu N) |
|
Valemetostat (DS-3201) |
|
|
First-in-Human Study of the EZH1/2 Dual Inhibitor DS-3201b in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)— Interim Results Focusing on Adult T-Cell Leukemia-Lymphoma (ATL) |
Abstract #4025; Poster Presentation (Morishima S)
|
|
Anti-tumor Effect of the EZH1/2 Inhibitor Valemetostat Against Diffuse Large B-Cell Lymphoma via Modulation of B-cell Receptor Signaling and c-Myc Signaling Pathways (preclinical data) |
Abstract #4642; Poster Presentation (Hama Y)
|
|
Milademetan (DS-3032) |
|
|
A Phase 1 Dose Escalation Study of Milademetan in Combination with 5-Azacitidine (AZA) in Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) |
Abstract #3932; Poster Presentation (DiNardo C)
|
|
A Phase I Study of Milademetan in Combination with Quizartinib in Patients with Newly Diagnosed (ND) or Relapsed/Refractory FLT3-ITD Acute Myeloid Leukemia (AML) |
Abstract #1389; Poster Presentation (Daver N)
|
|
Dual Inhibition of MDM2 and XPO1 Induces Synergistic Apoptosis in Acute Myeloid Leukemia with Wild-type TP53 through Nuclear Accumulation of p53 and Suppression of c-Myc (preclinical data) |
Poster Presentation (Nishida Y)
|
|
PLX2853 |
|
|
Dose Escalation Study of BET Inhibitor PLX2853 in Patients with Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome |
Abstract #1391; Poster Presentation (Pemmaraju
N
)
|
|
A Novel Combination Regimen of BET and FLT3 Inhibition for FLT3-ITD Acute Myeloid Leukemia (preclinical) |
Abstract #1373; Poster Presentation (Lee L)
|
|
Bromodomain and Extraterminal (BET) Domain Inhibition with PLX51107 and PLX2853 Improves Survival and Decreases Acute GVHD Severity in Murine Models (preclinical) |
Abstract #4429; Poster Presentation (Choe
H)
|
About Quizartinib
Quizartinib, an oral FLT3 inhibitor, is the lead product in the AML Franchise of Daiichi Sankyo. Quizartinib currently is approved only for use in Japan under the brand name VANFLYTA® for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test. It was launched in Japan on October 10, 2019.
Enrollment into QuANTUM-First, a global, pivotal phase 3 study evaluating quizartinib in combination with standard chemotherapy in newly diagnosed FLT3-ITD AML was recently completed. Quizartinib is also in phase 1/2 development for pediatric and young adult relapsed/refractory FLT3-ITD AML in North America and Europe, and phase 1 development in combination with milademetan, an investigational MDM2 inhibitor, for relapsed/refractory FLT3-ITD AML and newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy in the U.S.
About Valemetostat
Valemetostat (DS-3201) is an investigational and potential first-in-class EZH1/2 dual inhibitor in phase 1 clinical development for hematologic cancers including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and non-Hodgkin lymphomas (NHLs) including adult T-cell leukemia/lymphoma (ATL/L), peripheral T-cell lymphoma (PTCL) and B-cell lymphomas. Valemetostat has received SAKIGAKE Designation for the treatment of adult patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) by the Ministry of Health, Labour and Welfare (MHLW) in Japan.
About Milademetan
Milademetan (DS-3032) is an oral selective MDM2 inhibitor currently in phase 1 development for solid and hematologic malignancies, including a combination study with quizartinib in patients with relapsed/ refractory FLT3-ITD AML or newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy in the U.S., EU and Japan; a single agent and combination study with 5-azacitidine, an inhibitor of DNA methylation, in patients with newly-diagnosed AML unfit for intensive chemotherapy, relapsed/refractory AML or high-risk MDS in the U.S.; and two single agent studies in lymphomas and solid tumors in the U.S. and Japan.
About PLX2853
PLX2853 is an investigational oral small molecule BET inhibitor currently in phase 1 development for AML and high-risk myelodysplastic syndrome (MDS) and phase 1/2 development for advanced solid tumors in the U.S. PLX2853 was discovered by Plexxikon Inc.
Valemetostat, milademetan and PLX2853 are investigational agents that have not been approved for any indication in any country. Safety and efficacy have not been established.
About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science pipeline, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/ immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191106005138/en/
Contact information
Global and US
Jennifer Brennan
Daiichi Sankyo, Inc.
jbrennan2@dsi.com
+1 908 992 6631 (office)
+1 201 709 9309 (mobile)
EU
Lydia Worms
Daiichi Sankyo Europe
lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751(office)
+49 176 11780861 (mobile)
Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Angelalign Technology (6699.HK) Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 21:56:00 EET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 19:46:00 EET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
Credit Derivatives Determinations Committees Membership applications for 202627.3.2026 18:30:00 EET | Press release
DC Administration Services, Inc. (DCAS) would like to invite all interested Members of ISDA to apply for a position as a member of the Credit Derivatives Determinations Committees. There is a separate Determinations Committee for each of the relevant regions. Members of ISDA may apply for membership as either a Dealer Member of the Determinations Committees or a Non-Dealer Member of the Determinations Committees (as applicable). Parties wishing to apply for such a position should carefully review and submit either an executed Dealer Participation Letter (for a prospective Dealer Member) or an executed Non-dealer Committee Participation Letter (for a prospective Non-Dealer Member) by 5pm (New York time) on Friday, April 3, 2026. CCPs may also apply to participate as a CCP Member by submitting a Participating CCP Institution Letter. For more information on the process and to download the form of the relevant letter, please visit https://www.cdsdeterminationscommittees.org/about-dc-commit
Klarna Partners With EuroParcs to Offer Flexible Payments for Holiday Park Stays Across Europe27.3.2026 16:04:00 EET | Press release
Klarna, the global digital bank and flexible payments provider, today announces a new partnership with EuroParcs, one of Europe's fastest-growing holiday park operators. The collaboration gives holidaymakers in Germany, the Netherlands, Belgium, and Austria more flexibility in how they pay for their getaway. Guests booking through EuroParcs can now choose from a range of Klarna payment options tailored to their market: Germany & Austria: Pay in Full, Pay in 30 Days, Pay in 3, and Financing Netherlands: Pay in Full, Pay in 30 Days, and Pay in 3 Belgium: Pay in Full and Pay in 30 Days Nicole Defren, Head of Europe at Klarna, says: "Booking a holiday should feel exciting, not complicated – and that includes how you pay for it. With Klarna, EuroParcs guests can choose the payment option that suits them best, whether that's paying upfront, in a few weeks, or spreading the cost over time. From a cosy chalet on the Veluwe to a luxury villa in the Austrian Alps, we're making it easier for fami
Askey and Canoga Perkins Announce Strategic Collaboration at MWC Barcelona to Deliver Rapid-Deploy 5G Critical Communications Solutions27.3.2026 13:00:00 EET | Press release
Askeyand Canoga Perkinsannounced at Mobile World Congress Barcelona a Global Partnership to Deliver SyncMetra® Network Connectivity Solution, combining Canoga Perkins’ software-defined, IT-operated private 5G network transport along with Askey’s carrier-grade 5G radio access technology. At MWC Barcelona 2026, Askey Computer Corporation and Canoga Perkins announced a strategic partnership to deploy Canoga Perkins' SyncMetra® Platform across enterprise and service provider markets with Askey. This partnership pairs Askey’s carrier-grade radio access capabilities with Canoga Perkins’ industry-leading time-sensitive networking (TSN) and synchronization technology, enabling customers to simplify deployment of ultra-low-latency, highly reliable network services for 5G, edge compute, industrial automation, and mission-critical enterprise applications. The partnership enables joint go-to-market efforts, integrated product offerings, and expanded access to SyncMetra through Askey’s sales channe
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom