Daiichi Sankyo Submits New Drug Application in Japan for Valemetostat, a First-in-Class EZH1/EZH2 Dual Inhibitor, for Relapsed/Refractory Adult T-Cell Leukemia/Lymphoma

News on January 20, 2022 /BioValleyBIOON/ -- Daiichi Sankyo recently announced that it has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for valemetostat, a potential first-in-class dual inhibitor of EZH1 and EZH2, for the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma (ATL).Valemetostat has the potential to become the world's first globally approved EZH1 andEZH2Dual Inhibitor,Will provide a new targeted treatment option for patients with relapsed or refractory ATL.

ATL is a rare and aggressive peripheral T-cell lymphoma (PTCL) with higher incidence rates in certain parts of Japan and other regions. Currently, the prognosis for ATL patients is poor, with nearly 90% of patients relapsing after completing intensive first-line treatment, leaving almost no available options at that stage.

Valemetostat is a potent, selective, small-molecule inhibitor designed to target EZH1 andEZH2Enzyme Against EpigeneticsGeneticsDysregulation. Currently, valemetostat is being developed for the treatment of relapsed or refractory ATL, peripheral T-cell lymphoma (PTCL), and non-Hodgkin lymphoma (NHL). Previously, valemetostat has been granted approval in the United States.FDAGranted Orphan Drug Designation (ODD) for the treatment of PTCL, received ODD for the treatment of ATL and SAKIGAKE (Innovative Drug) designation for the treatment of PTCL from Japan's MHLW.

This NDA is based on the results of a pivotal Phase 2 clinical study. The study was conducted in Japanese patients with three aggressive subtypes of relapsed or refractory ATL, and the relevant data were presented at the 2021 American Society of Hematology (ASH) Annual Meeting.

The results showed that the study met the primary endpoint: according to the evaluation of the Independent Efficacy Assessment Committee,In 25 patients with relapsed/refractory ATL, the objective response rate (ORR) was 48%.Among them, 5 cases achieved complete response (CR), 7 cases achieved partial response (PR), and 10 cases had stable disease (SD). At the median follow-up of 6.5 months, the median duration of response (DOR) was not reached (95% CI: 1.87 months - not reached [NR]).

Adult T-cell leukemia/lymphoma (ATL) is a rare aggressive peripheral T-cell lymphoma (PTCL) caused by human T-lymphotropic virus type 1 (HTLV-1). Globally, every yearDiagnosisMore than 3,000 new cases of ATL are reported each year. In areas where the HTLV-1 virus is endemic, including southwestern Japan, Central and South America, and central Australia, the incidence of ATL is higher. Cases have also been observed in North America and Europe. In non-endemic regions, the incidence of ATL is also on the rise. In Japan, there are approximately 1,000 new cases of ATL annually, with over 1,000 deaths from ATL each year.

Compared with other types of PTCL, ATL has the poorest prognosis, with a 5-year overall survival rate of approximately 14%. The median survival time for patients with the most common acute ATL subtype in Japan has been reported to be about 8 months (252 days).

The treatment of ATL is based on subtypes, mainly including intensive multi-drug chemotherapy regimens. Nearly 90% of patients relapse after completing intensive first-line treatment, at which point there are almost no available treatment options. In Japan and other regions around the world, there is an urgent need for additional treatment methods to improve the prognosis of ATL treatment. (Bioon.com)

Source of Original Text:Valemetostat New Drug Application Submitted in Japan for Treatment of Patients with Adult T-Cell Leukemia/Lymphoma