- The first patient has been dosed in Epizyme's (NASDAQ:EPZM) Phase 2 clinical trial assessing lead product candidate tazemetostat in adult patients with genetically defined tumors, specifically INI1-negative tumors, certain SMARCA4-negative tumors and synovial sarcomas, all aggressive cancers with limited treatment options.
- The study will enroll up to 90 subjects in three cohorts. Patients will receive 800 mg of tazemetostat tablets twice daily. The primary endpoint is overall response rate (ORR) for patients with INI1-negative tumors and progression-free survival (PFS) for those with synovial sarcoma.
- Tazemetostat is a small molecule inhibitor of EZH2, an enzyme that is upregulated in certain cancers.
- The company expects to present interim results at a medical conference in late 2016. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is November 2017. The estimated study completion date is January 2018.
- Previously: Biotech sell-off submerges Epizyme despite encouraged data on tazemetostat; shares down 29% (Sept. 28)