Daiichi Sankyo Data at ASH Showcases Scientific and Clinical Advancements Across AML/Blood Cancer Portfolio
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
GoWit One: The Unified AI Operating System Set to Revolutionize Commerce & Retail Media4.12.2025 08:09:00 EET | Press release
GoWit, a global AdTech leader in omnichannel Commerce and Retail Media, announced the launch of GoWit One, the unified AI operating system that brings automation, unification, and real-time intelligence into a single ad platform for agencies operating across multiple retailers, channels, and markets. By bringing these three elements into one dashboard, GoWit One addresses the industry's most critical bottleneck: operational inefficiency. The platform enables agencies to manage campaigns across multiple retailers, channels, and markets, reducing manual AdOps workflows by 98%, turning a process that used to take hours into as little as 10 minutes. Solving the “Fragmentation Crisis” Despite the explosive growth of Retail Media, the industry faces a significant hurdle. According to the IAB, 70% of the market still lacks end-to-end AI adoption. Media buyers are currently forced to juggle disconnected networks, compliance rules, and dashboards, leading to manual errors and an inability to sc
Galderma Secures ‘BBB’ Credit Rating With Positive Outlook from S&P Global Ratings4.12.2025 08:00:00 EET | Press release
Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that S&P Global Ratings (S&P) has assigned the company a ‘BBB’ long-term issuer credit rating with a positive outlook. The rating reflects Galderma’s strong track record of growth and its leading positions across Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. S&P notes the company’s well-established brand portfolio, global footprint, including an expanding presence in emerging markets, and continued investment in science-based innovation. S&P highlights momentum from recent launches, including Nemluvio® (nemolizumab), alongside improving profitability and expanding free operating cash flow. The agency also notes Galderma’s disciplined financial policy, supporting expectations of continued deleveraging over the coming years. The positive outlook indicates that an upgrade could be considered over the next 12–24 months subject to Galderma continuing to deliver profitable g
NTT DATA Announces Six New AI-Powered Cyber Defense Centers to Strengthen Cyber Resilience and Counter an Evolving Threat Landscape4.12.2025 05:30:00 EET | Press release
NTT DATA, a global leader in AI, digital business and technology services, today announced the launch of four next-generation autonomous Cyber Defense Centers powered by AI technologies in Bengaluru, Hyderabad, Noida and Mumbai, with two additional centers set to open in Birmingham (UK) in Dec 2025 and Dallas (USA) by Jan 2026. These purpose-built Cyber Defense Centers reinforce NTT DATA’s strategic focus on modernizing cybersecurity for the AI era. They represent a shift from traditional centralized security operations to a distributed, AI-driven, hyper-automated model that learns from past incidents and human expertise to automate, triage and prioritize alerts, accelerate investigations and incident response, contain threats faster and support regional data privacy and cybersecurity regulations. According to Omdia, autonomous Security Operations Centers (SOCs) will become the industry standard within two years, positioning NTT DATA as a leading example of how the industry is evolving
YES Announces Leadership Transition as Rezwan Lateef Appointed Chief Executive Officer3.12.2025 21:24:00 EET | Press release
YES (Yield Engineering Systems), a leading provider of high-performance process solutions for the semiconductor Advanced Packaging market, today announced that Rezwan Lateef has been appointed Chief Executive Officer. Mr. Lateef previously served as President of YES and has been a key driver of the company’s significant growth, global expansion, and product innovation over the past several years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251202200541/en/ Rezwan Lateef, CEO of YES. The transition marks a natural progression for the company as it surpasses a key revenue milestone and enters its next phase of scaling with top tier semiconductor and AI computing customers. Rama Alapati, who has served as CEO since 2021, will step into a consulting role to support Mr. Lateef during the transition period and ensure strong organizational continuity. “Rama has played an instrumental role in elevating YES from a promising techno
Doha Debates Examines How Entertainment Shapes Us Today3.12.2025 19:13:00 EET | Press release
Qatar Foundation’s Doha Debates continues its flagship debate series with a new episode that examines how modern entertainment shapes our attention, creativity, and everyday well-being. Moderated by Dareen Abughaida, the debate brings together three influential thinkers to ask whether today’s entertainment landscape is enriching us—or overwhelming us. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251203737439/en/ Doha Debates examines how entertainment shapes us today in a new episode, leading thinkers and students debate whether today’s entertainment elevates us or pulls us into distraction. (Photo: AETOSWire) This week’s debate features Marya Bangee, Senior Advisor at the Pop Culture Collaborative; Dr. Anna Lembke, Professor of Psychiatry at Stanford University and author of Dopamine Nation; and Nicholas Carr, Pulitzer Prize finalist and author of The Shallows. For Bangee, the power of entertainment lies in storytelling t
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