Daiichi Sankyo announced the launch of EZHARMIA (valemetostat tosilate), a first-in-class dual inhibitor of EZH1 and EZH2, in Japan for the treatment of patients with relapsed or refractory adult T-cell leukemia-lymphoma (ATLL).

Marketing approval of EZHARMIA was granted by Japan’s Ministry of Health, Labor and Welfare (MHLW) in September 2022 based on results of an open-label, single-arm pivotal phase 2 study in 25 patients with three aggressive subtypes of relapsed or refractory ATLL in Japan. Data from the trial demonstrated an objective response rate (ORR) of 48% (95% CI: 27.8%-68.7%).

“Patients in Japan with relapsed or refractory adult T-cell leukemia-lymphoma, who have had limited treatment options beyond intensive chemotherapy, now have access to EZHARMIA, the first dual inhibitor of EZH1 and EZH2 to be approved for treatment of ATLL,” said Yoshinori Kaneshima, Corporate Officer, Head of Marketing Division, Japan Business Unit, Daiichi Sankyo.

“EZHARMIA is a new and novel therapy discovered by Daiichi Sankyo and is the fifth innovative oncology medicine we have launched in Japan in the past three years.”

EZHARMIA was generally well-tolerated in the phase 2 study. Drug-related treatment emergent adverse events (TEAEs) occurred in 24 of 25 patients (96%) with the most common TEAEs being platelet count decreased (80%), anemia (44%), alopecia (40%), dysgeusia (36%), lymphocyte count decreased (20%), neutrophil count decreased (20%) and white blood cell count decreased (20%).