BASKING RIDGE, N.J. and MUNICH, Nov. 14, 2017 /PRNewswire/ -- Daiichi Sankyo Company,
Updated data from the ongoing phase 1 study of DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), in HER2-positive metastatic breast cancer as well as patients with HER2 low-expressing breast cancer will be highlighted as a Spotlight Poster Discussion at SABCS.
Data to be presented at ASH comprises multiple abstracts including preliminary phase 1 data on DS-3201, an investigational dual EZH1/2 inhibitor, in relapsed or refractory non-Hodgkin's lymphomas, a bone marrow and peripheral blood concordance analysis for assessing FLT3-ITD mutated acute myeloid leukemia (AML) from screened patients in the global, randomized phase 3 QUANTUM-R study of quizartinib monotherapy versus salvage chemotherapy in relapsed/refractory AML, and preclinical data supporting the potential role of inhibiting MDM2-p53 interaction as a novel therapeutic strategy for hematological malignancies.
"These data reinforce our commitment to advancing science and accelerating development of several compounds for patients suffering from breast or blood cancer," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "We look forward to sharing further insights on our smart chemotherapy ADC platform and its flagship DS-8201 for HER-2 expressing tumors at SABCS as well as presenting preliminary clinical data on DS-3201, our dual EZH1/2 inhibitor, at ASH."
San Antonio Breast Cancer Symposium Presentation
American Society of Hematology Presentations
DS-8201, quizartinib, DS-3201 and DS-5272 are investigational agents that have not been approved for any indication in any country. Safety and efficacy of these investigational agents have not been established.
About DS-8201DS-8201 is the lead product in the ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Using Daiichi Sankyo's proprietary ADC technology, DS-8201 is a smart chemotherapy comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor (DXd) payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.
DS-8201 is currently in phase 2 clinical development for HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01) and phase 1 development for other HER2-expressing advanced/unresectable or metastatic solid tumors.
DS-8201 has been granted Breakthrough Therapy designation for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1), and Fast Track designation for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA).
About QuizartinibThe lead product in the AML Franchise of the Daiichi Sankyo Cancer Enterprise, quizartinib is an investigational oral selective FLT3 inhibitor currently in phase 3 development for relapsed or refractory (QuANTUM-R) and newly-diagnosed (QuANTUM-First) AML with FLT3-ITD mutations. Quizartinib has been granted Orphan Drug Designation by the FDA and European Medicines Agency (EMA) for the treatment of AML. Quizartinib also has been granted Fast Track designation by the FDA for the treatment of relapsed or refractory AML.
About DS-3201 Part of the AML Franchise of the Daiichi Sankyo Cancer Enterprise, DS-3201 is the first investigational dual EZH1/2 inhibitor currently in phase 1 clinical development for hematologic cancers including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and non-Hodgkin's lymphoma (NHL).
About Daiichi Sankyo Cancer EnterpriseThe vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking in order 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 our Antibody Drug Conjugate (ADC) and Acute Myeloid Leukemia (AML) Franchises, our cancer pipeline includes more than 20 small molecules, monoclonal antibodies and ADCs stemming from our powerful research engines: our 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. Compounds in development include: quizartinib, an oral FLT3 inhibitor, for newly-diagnosed and relapsed or refractory AML with FLT3-ITD mutations; DS-8201, an ADC for HER2-expressing breast and gastric cancer, and other HER2-expressing solid tumors; and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT), which is also being explored in a range of solid tumors in combination with the anti-PD1 immunotherapy pembrolizumab. For more information, please visit: www.DSCancerEnterprise.com.
About Daiichi SankyoDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit: www.dsi.com.
Contact Jennifer BrennanDaiichi Sankyo, Inc.firstname.lastname@example.org+1 908 992 6631(office)+1 201 709 9309 (mobile)
View original content:http://www.prnewswire.com/news-releases/data-at-sabcs-and-ash-demonstrate-daiichi-sankyo-commitment-to-advancing-science-in-breast-and-blood-cancer-300555126.html
SOURCE Daiichi Sankyo Company, Limited
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