Clinical-stage biopharmaceutical firm Epizyme has enrolled the first subject in its Phase II trial of clinical candidate, tazemetostat (EPZ-6438), in patients with relapsed or refractory non-Hodgkin lymphoma (NHL).

EZH2 is a histone methyltransferase (HMT) that is expected to play a potential oncogenic role in a multiple cancers.

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Tazemetostat is a first-in-class small molecule inhibitor of EZH2 and is the second HMT inhibitor to enter human clinical development.

The five-arm trial will enrol approximately 150 patients with germinal centre diffuse large B cell lymphoma (DLBCL) or follicular lymphoma, stratified into those expressing mutant EZH2 and those expressing wild type EZH2, as well as patients with non-germinal centre DLBCL.

"Tazemetostat is a first-in-class small molecule inhibitor of EZH2 and is the second HMT inhibitor to enter human clinical development."

The Phase II NHL study will evaluate the safety and activity of tazemetostat in patients with relapsed or refractory non-Hodgkin lymphoma.

The trial will enrol about 30 patients in each arm, prospectively stratified for EZH2 mutation status and cell-of-origin, assuming each arm of the trial achieves its primary response rate goal in its first stage.

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The five study arms are enrolling relapsed/refractory patients with germinal centre DLBCL with mutant EZH2, germinal centre DLBCL with wild-type EZH2 , follicular lymphoma with mutant EZH2, follicular lymphoma with wild-type EZH2 and non-germinal centre DLBCL.

Epizyme plans to start Phase II study of tazemetostat in adult patients with INI1-deficient solid tumours in the later part of the year and Phase II trial in paediatric patients with INI1-deficient solid tumours is also expected to begin at the same time.

In addition, the firm intends to begin additional clinical evaluations of tazemetostat, including a combination with R-CHOP in patients with DLBCL, and a combination with a B-cell signalling agent or other emerging targeted therapies for B-cell lymphomas.