June 20, 2018 5:42 AM ET

Biotechnology

Company Overview of Epizyme, Inc.

Company Overview

Epizyme, Inc., a clinical stage biopharmaceutical company, discovers and develops novel epigenetic medicines for patients with cancer and other diseases in the United States. Its product candidates include tazemetostat, an inhibitor of the EZH2, which is in Phase II clinical trial for patients with relapsed or refractory non-hodgkin lymphoma (NHL); Phase II clinical trial for relapsed or refractory patients with mesothelioma; Phase I dose-escalation and expansion study for children with INI1-negative solid tumors; Phase II clinical trials for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL); Phase Ib/II clinical trial in elderly patients with DLBCL; and Phase II cli...

400 Technology Square

4th Floor

Cambridge, MA 02139

United States

Founded in 2007

131 Employees

Phone:

617-229-5872

Fax:

617-349-0707

Key Executives for Epizyme, Inc.

Epizyme, Inc. does not have any Key Executives recorded.

Epizyme, Inc. Key Developments

Epizyme, Inc. Presents at 23rd Congress of the European Hematology Association, Jun-15-2018

Epizyme, Inc. Presents at 23rd Congress of the European Hematology Association, Jun-15-2018 . Venue: Stockholmsmässan: Mässvägen 1, 125 80 Älvsjö, Stockholm, Sweden.

Epizyme, Inc. Reports Positive Updated Interim Data from Phase 2 Study of Tazemetostat in Patients with Relapsed or Refractory Follicular Lymphoma

Epizyme, Inc. announced positive interim data from an ongoing Phase 2 study of its lead candidate tazemetostat, a potent, selective, orally available EZH2 inhibitor, as a monotherapy for patients with relapsed or refractory follicular lymphoma (FL). The data, presented at the 23rd Congress of the European Hematology Association (EHA) in Stockholm, show that tazemetostat demonstrated meaningful clinical activity and was generally well tolerated in these heavily pre-treated patients. Interim data as of May 1, 2018 included 82 evaluable patients across two cohorts, prospectively assigned by EZH2 status. In the EZH2 activating mutation cohort (n=28), an objective response rate (ORR) of 71% was observed; 11% of patients achieved a complete response (CR), and 61% achieved a partial response (PR). 29% achieved stable disease (SD) as best response; of those, 21% are still on study with the potential to respond. All patients in this cohort experienced reduction in tumor burden, and no patients experienced progressive disease (PD) as best response. At the time of this analysis, the median progression-free survival (PFS) was 49 weeks and the median duration of response (DOR) was 32 weeks, and both endpoints continue to mature. In the fully-enrolled cohort of FL patients with wild-type (WT) EZH2 (n=54), the ORR was 33%; 6% achieved a CR, and 28% achieved a PR. An additional 31% of patients achieved SD as best response, including one patient who is still receiving treatment. At the time of this analysis, the median PFS was 30 weeks and median DOR was 76 weeks. The median DOR figure continues to mature, with more than half of the responders still on therapy.

Epizyme, Inc. Announces Phase 2 Data of Tazemetostat for Malignant Mesothelioma

Epizyme, Inc. announced the first detailed results from the Phase 2 study of its lead candidate tazemetostat, a potent, selective, orally available EZH2 inhibitor, in relapsed/refractory malignant mesothelioma patients with BRCA1-associated protein 1 (BAP1) loss-of-function. The data will be presented during a poster and subsequent discussion session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The primary endpoint was met with 51 percent of patients (31/61) having achieved disease control at 12 weeks, exceeding the pre-specified disease control rate (DCR) threshold of =35%. DCR is defined as complete response, partial response (PR) or stable disease. As of January 16, 2018, 16 patients (26%) had maintained disease control for =24 weeks since starting treatment with tazemetostat, two of whom achieved PR. Patients enrolled in the study were heavily pretreated, with a median of two prior lines of therapy. The Phase 2, multicenter, open-label study was designed to evaluate 800 mg of tazemetostat monotherapy administered orally twice daily in adult patients with measurable relapsed/refractory malignant mesothelioma. The trial enrolled 74 patients and was conducted in two parts: the first part enrolled patients regardless of BAP1 status (n=13) to evaluate the safety and pharmacokinetics (PK) of tazemetostat. The second part enrolled patients with BAP1 loss-of-function (n=61) to determine DCR. Secondary endpoints included overall response rate, progression-free survival, overall survival, safety, population PK and response biomarkers. Consistent with findings from adult studies across the tazemetostat clinical development program, tazemetostat was generally well tolerated. No patients discontinued due to treatment-emergent adverse effects (TEAEs); five patients had dose reductions due to TEAEs. The five most frequently reported TEAEs (all grades) were fatigue (32%), decreased appetite (28%), dyspnea (28%), nausea (27%), and cancer pain (26%), regardless of relationship to study drug.

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