Epizyme reports interim Phase II data for tazemetostat in sarcomas

In an abstract released ahead of the American Society of Clinical Oncology meeting in Chicago, Epizyme Inc. (NASDAQ:EPZM) reported interim data from a cohort of 31 evaluable patients with SWI/SNF related matrix associated actin dependent regulator of chromatin subfamily b member 1 (SMARCB1; SNF5; INI1)-negative relapsed or refractory epithelioid sarcoma in a Phase II trial showing that twice-daily 800 mg oral tazemetostat (E7438, EPZ-6438) led to a disease control rate (DCR), the cohort’s primary endpoint, of 32%, including 4 confirmed partial responses and 6 cases of stable disease for ≥32 weeks. Tazemetostat led to median progression-free survival (PFS) of 5.7 months and median duration of response of 7 months in the epithelioid sarcoma cohort. Next year, Epizyme plans submit an NDA to FDA seeking accelerated approval for tazemetostat to treat epithelioid sarcoma based on data from the cohort.

Additionally, Epizyme said it will not advance tazemetostat as a monotherapy to treat synovial sarcoma after the product led to 10 cases of stable disease in a cohort of 33 evaluable synovial sarcoma patients. No objective responses were observed in the cohort...