Advertisement Epizyme begins dosing in Phase II trial for tazemetostat to treat relapsed or refractory NHL - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Epizyme begins dosing in Phase II trial for tazemetostat to treat relapsed or refractory NHL

US-based biopharmaceutical firm Epizyme has started dosing patients in the Phase II trial of its lead clinical candidate, tazemetostat (EPZ-6438), to treat relapsed or refractory non-Hodgkin lymphoma (NHL).

Around 150 patients with germinal center 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 center DLBCL, will be enrolled in this five-arm Phase II trial.

The multi-center, international trial will evaluate the safety and activity of tazemetostat in patients with relapsed or refractory non-Hodgkin lymphoma.

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

Epizyme chief development officer Peter Ho said: "Results from our ongoing phase 1 trial that we presented at the International Congress on Malignant Lymphoma on June 20 show tazemetostat produced durable objective responses in heavily pre-treated patients with relapsed or refractory NHL, with an acceptable safety and tolerability profile.

"With the initiation of this phase 2 trial, we look forward to making significant progress in evaluating the potential of tazemetostat in targeted sub-populations of NHL."

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

Later this year, the company intends to start a second planned Phase II trial of tazemetostat in adult patients with INI1-deficient solid tumors.

A Phase I trial in pediatric patients with INI1-deficient solid tumors is also expected to be initiated later this year.

The company also plans to begin additional clinical evaluations of tazemetostat, including a combination with R-CHOP in patients with DLBCL, and a combination with a B-cell signaling agent or other emerging targeted therapies for B-cell lymphomas.