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
Laserfiche’s Taylor Grosso Honored as 2026 CRN® Channel Chief2.2.2026 17:00:00 EET | Press release
Laserfiche — the leading SaaS provider of intelligent content management — announced today that CRN® — a brand of The Channel Company — has selected Taylor Grosso, senior director, channel, Americas, as a 2026 CRN® Channel Chief. This annual recognition celebrates IT vendor and distribution executives who are shaping channel strategy and driving innovation and partnership across the industry. Grosso oversees Laserfiche’s Americas channel sales team, including the U.S., Canada, and Latin America, focusing on empowering Laserfiche Solution Providers to stay competitive as the market evolves. As more organizations seek out AI-powered tools to enhance productivity, Grosso prepares partners with the resources they need to quickly learn and sell Laserfiche’s industry-leading AI-powered document management solutions. By working closely with partners on building targeted business plans, Grosso and his team enable faster customer adoption of AI while driving revenue growth. “Over the past year,
Conga Completes Acquisition of PROS B2B Business2.2.2026 16:55:00 EET | Press release
Conga, a leader for AI-powered innovation in configure, price, quote (CPQ), contract lifecycle management (CLM), and document automation, today announced it has completed the acquisition of the B2B business of PROS Holdings, Inc (“PROS”) from certain investment funds affiliated with Thoma Bravo, the world’s largest software-focused investment firm. This transaction unites two industry leaders to help enterprises maximize revenue, reduce risk, and improve profitability. By bringing together AI-driven pricing optimization, configuration, quoting, and contracting capabilities, the combined company creates a differentiated enterprise platform that connects the commerce chain and enables end-to-end revenue orchestration from price to signature. The expanded Conga leadership team will continue to be led by CEO Dave Osborne. “To operate as connected, intelligent businesses, enterprises need a commerce chain that keeps everyone moving in the same direction,” said Osborne. “By bringing Conga an
Arcesium Acquires Limina to Deliver a Unified Front-to-Back Investment Platform2.2.2026 16:00:00 EET | Press release
Arcesium, a leading global financial technology provider to the investment industry, today announces its acquisition of Stockholm-based portfolio and order management (P/OMS) systems provider, Limina, creating a full front-to-back operating platform tailored to the unique needs of asset managers, hedge funds and asset owners. Through the integration of Limina’s P/OMS with Arcesium’s middle- and back-office solutions, the combined offering will be designed to eliminate legacy fragmentation and connect siloed data, providing investment managers with the speed and insight they need to operate intelligently across asset classes and global markets. The entire Limina team will join Arcesium and play a key role in ongoing product development, advancing Arcesium’s commitment to optimizing the pre- and post -investment journey for the world’s most sophisticated financial firms. Limina CEO, Kristoffer Fürst, will join Arcesium, reporting to Arcesium President, Product and Technology, Bryan Dough
KiddeFenwal Launches New Line of Gas Ignition Controls for European and APAC Markets2.2.2026 16:00:00 EET | Press release
KiddeFenwal, the global leader in the fire suppression and safety controls industry, today introduces its 35-2X Series, a new line of direct spark gas ignition controls for original equipment manufacturers (OEMs) in and serving European and Asia-Pacific markets. The series delivers highest quality gas ignition and safety modules supporting 230 VAC applications. The launch marks the next phase of KiddeFenwal’s global growth in the safety controls space, expanding its reach in Europe, Asia and Australia while building on its established North American presence. The company is offering the 35-2X Series via its trusted Fenwal Controls brand, which has served OEMs with reliable products and expert technical advice since 1935. “KiddeFenwal continues to bring new critical control solutions to market, meeting the evolving needs of OEMs and their range of customers worldwide,” said Rekha Agrawal, CEO of KiddeFenwal. “From increasing product complexity to rising energy prices, we deeply understa
Klarna Backs Google’s Universal Commerce Protocol (UCP) to Enable Agentic Commerce Across Platforms2.2.2026 15:30:00 EET | Press release
Klarna, the global digital bank and flexible payments provider, is joining Google's Universal Commerce Protocol (UCP), an open standard designed to help AI agents and commerce systems work together across the full shopping lifecycle, from discovery and purchase through post-purchase support. UCP enables consumers to shop seamlessly in AI conversations while giving agents, merchant systems, and payment providers a standardized way to interact across multiple AI platforms. The announcement builds on Klarna’s recent support for Google’s Agent Payments Protocol (AP2) and expands Klarna's multiyear partnership with Google across Google Pay, Google Store, Google Play, and Google Cloud infrastructure. Together, these efforts reflect ongoing collaboration to support open standards as AI increasingly shapes how consumers shop online. “As AI-driven shopping continues to evolve, it’s important that the underlying commerce infrastructure is built on openness, trust, and transparency,” said David S
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