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
Dubai Launches Global Create AI Agents Championship with Prize Pool Exceeding AED 2.5 Million8.10.2026 20:05:00 EEST | Press release
Dubai has launched the Create AI Agents Championship, a global competition inviting innovators to develop practical and scalable AI-agent solutions that address real-world challenges, with a total prize pool exceeding AED 2.5 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261008883373/en/ Dubai has launched the Create AI Agents Championship as part of its efforts to accelerate the adoption and development of Agentic AI (Photo: AETOSWire) The launch of the championship was announced by H.H. Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, Crown Prince of Dubai, Deputy Prime Minister and Minister of Defence of the UAE, and Chairman of The Executive Council of Dubai, who encouraged innovators from around the world to participate. Led by Dubai Chamber of Digital Economy, the championship aims to accelerate the adoption of Agentic AI and support the development of innovative AI-agent solutions with strong potential for
Seiden Law LLP issues statement: Prosecuted by Press Conference: Declared Guilty Without a Charge, Yim Leak Family Asks UN Human Rights Experts to Hold Thailand to Its Own Treaty Commitments8.10.2026 19:26:00 EEST | Press release
Seiden Law LLP, chief global counsel to Cambodian businessman Yim Leak, announced today that Jared Genser, international counsel to Mr. Yim and his wife, has asked two UN Special Rapporteurs to send an urgent appeal to the Thai government. The request is made on behalf of the couple and their seven-year-old son. It says Thailand violated its international human rights commitments by announcing the family’s guilt before any court had tried them, and by freezing their assets, including their minor son’s savings, without a hearing. Six Official Statements in Nine Months. No Charge Filed in Any Court. Between December 2025 and September 2026, Thai officials described Mr. Yim as the center of a criminal network on six occasions: at two press conferences chaired by the head of the Thai government, in the House of Representatives, and in three government press releases. The head of the Thai government said the network had been “found to have committed” offenses. Asked about the suspects’ lawy
Sam Altman-Backed Meanwhile Raises $37.5M as Families Across Asia, Europe and the Middle East Turn to Bitcoin Life Insurance8.10.2026 19:12:00 EEST | Press release
Meanwhile, the first life insurer licensed to operate entirely in Bitcoin, today announced $37.5 million in new funding from its existing investors. Bain Capital Crypto led the round, alongside Haun Ventures, Framework Ventures, Pantera Capital, Apollo, Northwestern Mutual Future Ventures, and Morgan Creek Digital. Meanwhile, whose backers also include Sam Altman, has now raised more than $180 million. The round follows a surge in international demand for Meanwhile’s Bitcoin life insurance policies, particularly in Asia, Europe and the Middle East amid broader macro instability. In early 2026, Meanwhile launched BTC Life 1-Pay, a single-premium whole life policy built for high-net-worth clients outside the United States. It is the company's second product line after BTC 10-Pay, which is purposely designed for US taxpayers. As the company eyes further international growth, Meanwhile has signed 15 brokers serving wealthy families since launch, including in the insurance hubs of Singapore
Andersen Consulting Adds TalentSmartEQ to Advance Leadership and Business Transformation8.10.2026 17:38:00 EEST | Press release
Andersen Consulting expands its human capital capabilities through a Collaboration Agreement with TalentSmartEQ, a San Diego-based firm focused on creating practical, engaging and actionable learning experiences rooted in emotional intelligence (EQ) and leadership development. For more than two decades, TalentSmartEQ has worked with organizations around the world to develop leadership skills through emotional intelligence, helping strengthen employee engagement, teamwork, and overall performance. The firm combines research-based methodology with practical learning experiences, assessments, coaching, and customized programs that are designed to translate EQ development into sustained changes in workplace behavior. As an industry leader, TalentSmartEQ works with organizations spanning Fortune 500 companies to government agencies and privately held businesses. “Organizations are asking more of their leaders and employees as the workplace continues to evolve,” said Howard Farfel, CEO of Ta
Toluna Announces Planned CEO Transition After 25 Years; Founder Frédéric Charles Petit to remain as Board Member, Senior Advisor and Shareholder8.10.2026 17:20:00 EEST | Press release
Toluna, a global leader in consumer insights and market research technology, today announces a planned leadership transition. After 25 years leading the company he founded, Frédéric Charles Petit, Founder and Chief Executive Officer, intends to transition from his role as CEO following the appointment of his successor as part of a carefully planned succession process designed to ensure continuity for clients, employees and partners. Following the transition, Mr. Petit will continue to serve on Toluna's Board of Directors, will remain a significant shareholder of the company, and will take on an ongoing strategic advisory role for areas central to Toluna's next phase of growth. The Board, in close consultation with Mr. Petit, has initiated a structured succession process. A comprehensive transition plan is in place, including a defined handover with Mr. Petit, to ensure continuity for the company’s clients, employees, and partners. The Board expects to confirm the appointment of the com
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