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Daiichi Sankyo’s EZH1/2 Dual Inhibitor Valemetostat (DS-3201) Receives SAKIGAKE Designation for Treatment of Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma from Japan MHLW
April 09, 2019
- SAKIGAKE Designation will provide development support and accelerated review of valemetostat, an investigational and potential first-in-class EZH1/2 dual inhibitor, for relapsed/refractory peripheral T-cell lymphoma (PTCL)
- There is a need for new treatment options for adult patients with PTCL, a group of non-Hodgkin lymphomas that tend to be aggressive and associated with poor prognosis, particularly for relapsed disease
- Phase 1 trial with valemetostat is currently enrolling patients with relapsed/refractory non-Hodgkin lymphomas including PTCLs in the U.S. and Japan
Tokyo, Basking Ridge, NJ, and Munich – (April 9, 2018) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that valemetostat (DS-3201), an investigational and potential first-in-class EZH1/2 dual inhibitor, has received SAKIGAKE Designation for the treatment of adult patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) by the Japan Ministry of Health, Labour and Welfare (MHLW).
“There is a need for new and novel treatment approaches for patients with peripheral T-cell lymphoma, a group of heterogenous diseases for which relapse rates tend to be high and options beyond systemic chemotherapy are limited,” said Kaszushi Araki, Valemetostat Global Team Leader, Oncology Clinical Development Department, Oncology Function, Daiichi Sankyo. “We look forward to working closely with the Japan Ministry of Health, Labour and Welfare to optimize development of valemetostat and to potentially offer a new, first-in-class targeted therapy option for patients with various subtypes of relapsed/refractory PTCL, including those that are more common in Japan.”
The SAKIGAKE Designation System promotes R&D in Japan, driving early practical application for innovative pharmaceutical products, medical devices, and regenerative medicines. As a designated medicine under the SAKIGAKE Designation System, valemetostat will have prioritized consultation, a dedicated review system to support the development and review process, as well as reduced review time from the normal 12 months to 6 months.
Valemetostat targets epigenetic regulation by inhibiting both the EZH1 (enhancer of zeste homolog 1) and EZH2 (enhancer of zeste homolog 2) enzymes that act through histone methylation to regulate gene expression. Reactivation of the silenced genes results in decreased proliferation of EZH2-expressing cancer cells.1 Preclinical research has shown that valemetostat suppressed trimethylation of H3K27 in cells more strongly than EZH2 selective inhibitors. Valemetostat also displayed antitumor activity in various hematological malignancies in preclinical models.2,
SAKIGAKE Designation was granted based on the preliminary results of an ongoing phase 1 study assessing the safety and efficacy of valemetostat in patients with non-Hodgkin lymphomas (NHL) including PTCLs, which were presented at the 2017 annual meeting of the American Society of Hematology (ASH).
About Peripheral T-Cell Lymphoma (PTCL)
Peripheral T-cell lymphoma (PTCL) is a subtype of non-Hodgkin lymphoma (NHL), a form of cancer that originates in lymphocytes, a type of white blood cell. The two main types of NHL are B-cell lymphomas and T-cell lymphomas, which are classified into subtypes based on the origin and stage of the cancer.
There are at least eight different types of PTCL. Each type is considered rare. Global incidence of PTCL subtypes varies by geographic region. Most, but not all, types of PTCL are aggressive, and patients are usually treated with systemic chemotherapy; relapse is common after initial treatment.8
The incidence of lymphoma, including NHL, is increasing year by year around the world. There were an estimated 509,000 new cases and about 248,000 deaths globally from NHL in 2018. In Japan, there were nearly 21,000 new cases of NHL in 2012. While recent treatment advances have led to improved outcomes for patients with certain types of NHL, patients with aggressive NHL subtypes or relapsed/refractory disease still face a poor prognosis.6,12
Part of the investigational AML Franchise of the Daiichi Sankyo Cancer Enterprise, valemetostat 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 lymphoma (NHL), including adult T-cell leukemia/lymphoma (ATL/L), peripheral T-cell lymphoma (PTCL), and B-cell lymphomas. Valemetostat is an investigational agent and has not been approved by the FDA or any other regulatory agency worldwide as a treatment for any indication. 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 Franchise, 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. Compounds in pivotal stage development include: DS-8201, an antibody drug conjugate (ADC) for HER2 expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations; and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.
About Daiichi Sankyo
Daiichi 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.
 Honma D, et al. 2017 ASH Annual Meeting Poster Presentation. Abstract #2073.
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 Maruyama D, et al. 2017 ASH Annual Meeting Poster Presentation. Abstract #4070.
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 Suzumiya J, International Journal of Hematology (2018). Progress in Hematology. 107:392–394
 Bray F, et al. GLOBOCAN 2018. CA CANCER J CLIN 2018;68:394–424.
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