Epizyme, Inc., a clinical stage biopharmaceutical company, discovers and develops novel epigenetic therapies for patients with cancer and other diseases in the United States. Its product candidates include tazemetostat, an inhibitor of the EZH2 HMT, which is in five-arm 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 and Ib clinical trials for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL); Phase Ib/II clinical trial for elderly patients with DL...
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Founded in 2007
Epizyme, Inc. Announces Positive Interim Data on its First-In-Class EZH2 Inhibitor, Tazemetostat
May 18 17
Epizyme, Inc. announced positive interim data on its first-in-class EZH2 inhibitor, tazemetostat, from the epithelioid sarcoma cohort of its ongoing Phase 2 study in adult patients with molecularly defined solid tumors. In addition, the company announced that it recently conducted a positive meeting with the U.S. Food and Drug Administration (FDA) to discuss the registration strategy for tazemetostat for the treatment of epithelioid sarcoma. Based on discussions with the FDA, the company has identified a path to submission for accelerated approval of tazemetostat based on the 60-patient cohort from its Phase 2 study, and will target a New Drug Application (NDA) submission in 2018. An interim assessment of the epithelioid sarcoma cohort of patients (n=31), as of May 1, 2017, shows that treatment with tazemetostat resulted in a 32% disease control rate and a 13% overall response rate, with a median duration of response of seven months and ongoing. In addition, tazemetostat continues to demonstrate a favorable safety profile. Phase 2 Study in Molecularly Defined Solid Tumors: Epizyme’s Phase 2 study is evaluating the efficacy and safety of 800mg of tazemetostat orally administered twice-daily in adult patients with certain molecularly defined solid tumors, stratified into five different cohorts based on tumor type, including: epithelioid sarcoma, synovial sarcoma, malignant rhabdoid tumor, renal medullary carcinoma and other INI1-negative tumors. Epizyme will present interim efficacy data from the epithelioid sarcoma and synovial sarcoma cohorts and safety data from all cohorts at the American Society for Clinical Oncology (ASCO) Annual Meeting. The remaining three arms of the study have not yet reached futility assessment by the Independent Data Monitoring Committee. Epizyme anticipates providing updates from those cohorts later in 2017. Epithelioid Sarcoma Efficacy Data: The epithelioid sarcoma cohort in Epizyme’s Phase 2 study represents the prospective study of epithelioid sarcoma with any approved or investigational treatment to date. Epithelioid sarcoma is an ultra-rare and aggressive soft tissue sarcoma, characterized by a loss of the INI1 protein. It is most commonly diagnosed in young adults (20-40 years old) and is often fatal. There is no established standard-of-care for treating these patients, who are typically resistant to chemotherapy. The cohort was initially designed to enroll 30 patients, and was expanded to enroll an additional 30 patients in December 2016 based on encouraging early activity. The cohort has enrolled 49 front-line and relapsed or refractory epithelioid sarcoma patients out of a projected total of 60 patients. Interim data to be presented are from 31 patients in the initial study group, as of the data cutoff on May 1, 2017. In these patients, tazemetostat treatment resulted in a 32% disease control rate (DCR), the primary endpoint. DCR is comprised of confirmed objective responses by RECIST 1.1 for any duration or disease stabilization of 32 weeks or more. Thus far, four patients (13%) have achieved confirmed objective responses (all partial), and the time to response ranged from two months to six months. The median duration of response is seven months and ongoing. Prolonged disease stabilization of 32 weeks or more has been observed in six patients (19%), including two patients having stable disease for more than 15 months. These Phase 2 data complement the Company’s experience from its Phase 1 study, in which two of three patients with epithelioid sarcoma remain on tazemetostat with stable disease out over two years. A median progression-free survival (PFS) of 5.7 months has been observed, and initial assessment of overall survival for those patients in the DCR group compared to the non-DCR group showed distinct separation in survival curves, favoring the DCR group. The data from this cohort are still maturing, and an initial assessment suggests the potential for prolonged clinical benefit with tazemetostat treatment. These interim data will be presented at ASCO by Dr. Gounder in a poster titled “Phase 2 multicenter study of the EZH2 inhibitor tazemetostat in adults with INI1 negative epithelioid sarcoma (NCT02601950)” on June 4 (Abstract No.: 11058, Poster Board No.: 381). Tazemetostat Safety Profile: Tazemetostat has demonstrated a favorable safety profile in the Phase 2 study, particularly when considering the adverse effects associated with currently utilized chemotherapeutic regimens and other STS therapies. Safety data from patients in all study cohorts (n=121) are consistent with the overall safety profile observed in a nearly 400 patient-safety database from tazemetostat clinical trials to date, showing favorable tolerability without significant safety events. There were no discontinuations due to adverse events in any of the study cohorts. The majority of treatment-emergent adverse events (TEAEs) were grade 1 or 2, with only 12% of patients experiencing grade 3 or higher treatment-related TEAEs. Reported TEAEs regardless of attribution with an incidence of 10% or greater were fatigue (34%), dyspnea and nausea (27% each), cough (22%), decreased appetite (20%), vomiting (19%), constipation (18%), anemia (17%), diarrhea (16%), back pain and headache (12% each), pleural effusion (11%) and death and peripheral edema (10% each). All deaths that occurred during the study were attributed to the patients’ underlying disease and not to treatment with tazemetostat. There were no clinically relevant differences in the safety profile for either the epithelioid sarcoma or the synovial sarcoma cohorts compared to that of the entire study. Synovial Sarcoma Efficacy Data: The cohort of patients with synovial sarcoma (n=33) in the Phase 2 study completed enrollment in November 2016. Data show tazemetostat treatment resulted in stable disease as the best response in 10 patients (30%) with five patients (15%) meeting the primary endpoint of disease stabilization for 16 weeks or longer. The level of activity was determined to be insufficient to advance tazemetostat as a monotherapy for this tumor type. These data will be presented in a poster by Patrick Schöffski, M.D., Department of General Medical Oncology and the Laboratory of Experimental Oncology at the University Hospitals Leuven, KU Leuven, Belgium, titled “Phase 2 multicenter study of the EZH2 inhibitor tazemetostat in adults with synovial sarcoma (NCT02601950)” on June 4 (Abstract No.: 11057, Poster Board No.: 380).
Epizyme, Inc. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2017; Provides Guidance for 2017
May 8 17
Epizyme, Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2017. For the quarter, the company reported loss from operations of USD 32,964,000 compared to USD 22,879,000 a year ago. Net loss was USD 32,522,000 or USD 0.56 per basic and diluted share compared to USD 22,879,000 or USD 0.41 per basic and diluted share a year ago.
For 2017, the company believes, based on its current operating plan, that its cash, cash equivalents and marketable securities of USD 211.2 million as of March 31, 2017 will be sufficient to fund the company's planned operations into at least the third quarter of 2018.