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.
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.
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.
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.