Epizyme Reports Data From Phase 2 Trial Of Tazemetostat In Non-Hodgkin Lymphoma

(RTTNews) - Epizyme Inc. (EPZM) reported preliminary data from its ongoing, global Phase 2 clinical trial of orally administered tazemetostat, a first-in-class EZH2 inhibitor, in relapsed or refractory patients with non-Hodgkin lymphoma (NHL). Early data from the Phase 2 trial indicate that tazemetostat demonstrated a favorable safety profile and clinical activity consisting of objective responses in a heavily pre-treated patient population.

Epizyme's Independent Data Monitoring Committee confirmed that futility has been surpassed in four of the five study cohorts: diffuse large B-cell lymphoma (DLBCL) with Germinal Center B-cell (GCB) subtype and EZH2 mutations; DLBCL with GCB subtype and wild-type EZH2; DLBCL with non-GCB subtype; and, follicular lymphoma (FL) with EZH2 mutations. The fifth cohort enrolling patients with FL with wild-type EZH2 is ongoing, but has not yet reached futility assessment. The primary endpoint of the Phase 2 study is overall response rate, and secondary endpoints include progression-free survival and duration of response.

Trial enrollment is on track and consistent with incidence rates for NHL subtypes, with approximately 20% of enrolled DLBCL GCB and FL patients having EZH2 mutations.

Among the 47 efficacy-evaluable patients, both objective responses (complete responses (CR) and partial responses (PR)) and stable disease (SD) have been observed. In the Phase 1 experience, Epizyme observed responses that evolved over time from SD to PRs and CRs.

All of the patients who have achieved a CR and the majority of patients who have achieved a PR or SD as best response are still on tazemetostat treatment as of the data cutoff.

Epizyme is continuing to enroll patients in its ongoing Phase 2 study in patients with NHL, as well as in two clinical trials in patients with certain genetically defined solid tumors.