Tazemetostat: Preliminary Phase I/II data

Preliminary data from 47 evaluable relapsed or refractory NHL patients in the Phase II portion of an open-label, international Phase I/II trial showed that twice-daily 800 mg oral tazemetostat led to an ORR of 27.7%, including 4 complete responses and 9 partial responses, plus 13 cases of stable disease. Evaluable patients had 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; or follicular lymphoma with EZH2 mutations. Epizyme said an IDMC confirmed that “futility has been surpassed” in the 4 evaluable cohorts. The fifth cohort, which has enrolled 19 follicular lymphoma patients with wild-type EZH2, has not yet reached futility assessment. The most common treatment-related adverse events reported were nausea, asthenia, thrombocytopenia, neutropenia and fatigue. The trial is enrolling 270 patients. Data were presented at the American Society of Hematology meeting on Lymphoma Biology in Colorado Springs. Epizyme previously reported data from the Phase I portion of the trial (see BioCentury, March 9, 2015 & June 29, 2015). ...