Epizyme, Inc., a clinical-stage company developing novel epigenetic therapies, announced today that updated efficacy and safety data from the fully enrolled cohort of epithelioid sarcoma (ES) patients in its ongoing Phase 2 trial of tazemetostat will be presented in a poster discussion session at the European Society for Medical Oncology (ESMO) 2018 Congress to be held October 19-23 in Munich, Germany. Tazemetostat is the company's potent, selective, orally available, first-in-class EZH2 inhibitor.
The Phase 2 study ES cohort completed enrollment in 2017 with a total of 62 patients. Detailed data will be presented at the Congress, including objective response rate (ORR), the study's primary endpoint, and other important endpoints in this disease including duration of response, overall survival (OS), disease control rate and safety. For the first time, an analysis of ORR, durability and OS will be presented in both treatment-naive patients and in relapsed and/or refractory patients from the fully enrolled study cohort. Data will be presented by the study's primary investigator, Mrinal Gounder, M.D., attending physician, Sarcoma Medical Oncology and Early Drug Development Service, and assistant professor, Memorial Sloan Kettering Cancer Center.
"We are excited to share these updated efficacy and safety data on tazemetostat in patients with epithelioid sarcoma, a rare and deadly cancer," said Robert Bazemore, president and chief executive officer of Epizyme. "We remain committed to bringing this potential therapy to patients living with ES, and are confident as we progress towards our first NDA submission in the first half of 2019."
In addition to the ES data, Epizyme will present data from the company's Phase 2 study of tazemetostat in adult patients with INI1-negative tumors in two additional poster discussions and during one oral session at ESMO.