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31 Dec 2015

Epizyme announces first patient dosed in global clinical program evaluating tazemetostat in genetically defined solid tumours

US study sites now enrolling adults in registration-supporting Phase II study.

Epizyme has announced that the first patient has been dosed in the Phase II study of tazemetostat in adult patients with genetically defined tumours. The Phase I dose escalation study in pediatric patients with the same tumour types is also now open for enrollment. The cancers being studied in these trials, INI1-negative tumuors, certain SMARCA4-negative tumours and synovial sarcomas, are aggressive cancers that are poorly served by current treatments. The first sites activated for adult enrollment are Northwestern University, MD Anderson Cancer Center and Cincinnati Children’s Hospital and the first sites activated for pediatric enrollment are the Dana Farber Cancer Institute and Cincinnati Children’s Hospital. Additional study sites in the US, Canada, Europe and Australia are planned to be added over the upcoming months.

"Life-threatening rare tumors such as rhabdoid tumours, epithelioid sarcomas and synovial sarcomas affect children and young adults who are in need of novel effective therapies since the standard approaches are only marginally useful,” said George Demetri, Director, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School. “We are enthusiastic about evaluating tazemetostat in our patients with these forms of sarcomas since the molecular mechanism is so compelling, especially with the recent identification of mutations in INI1 or SMARCA4 as genetic drivers for these cancers."

“This important study will enroll children with cancers such as malignant rhabdoid tumour, based on unique genetic defects that appear to result in biological sensitivity to EZH2 inhibition,” said Susan Chi, Director of the Pediatric Brain Tumor Clinical Trials Program, Dana-Farber Cancer Institute and Assistant Professor of Pediatrics, Harvard Medical School. “For children with these deadly diseases, tazemetostat potentially represents a meaningful option when other treatments have been exhausted.”

“Initiation of the clinical program in genetically defined solid tumours is an important milestone for Epizyme and expands tazemetostat development beyond non-Hodgkin lymphoma,” said Peter Ho, Chief Medical Officer, Epizyme. “We are excited to advance the study of tazemetostat in these patients.”

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