CAMBRIDGE, Mass.--(BUSINESS WIRE)--Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that new data from the epithelioid sarcoma and follicular lymphoma cohorts of the company’s ongoing Phase 2 clinical trials of tazemetostat will be reported during oral presentations at medical meetings in June.
Updated data from the fully enrolled cohort of epithelioid sarcoma patients in the company’s molecularly defined solid tumor program will be presented at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting in Chicago. Updated data from the fully enrolled cohorts of patients with follicular lymphoma, both with and without EZH2 activating mutations, will be reported at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. The company will also report findings from its follicular lymphoma natural history study during a poster session at the 24th Congress of the European Hematology Association (EHA) in Amsterdam.
“The updated data to be presented at these upcoming meetings showcase tazemetostat’s potential to positively impact patients in need of new treatment options and, importantly, support the two planned NDA submissions this year,” said Robert Bazemore, president and chief executive officer of Epizyme. “We remain on track to submit our epithelioid sarcoma NDA to the U.S. FDA in the second quarter, followed by our planned NDA submission for follicular lymphoma patients, both with and without EZH2 mutations, in the fourth quarter of this year. We look forward to these data presentations and continuing our work to execute these pivotal milestones.”
Details of the presentations are listed below:
ASCO Oral Presentation
Title: Safety and efficacy of tazemetostat, a first-in-class EZH2 inhibitor, in patients (pts) with epithelioid sarcoma (ES) (NCT02601950)
Presenter: Silvia Stacchiotti, M.D., Fondazione IRCCS Istituto Nazionale Tumori, Milan
Abstract No.: 11003
Date: Monday, June 3, 2019; 9:00 – 9:12 a.m. CDT
EHA Poster Discussion
Title: EZH2 gain-of-function mutations are not associated with more favorable prognosis in relapsed/refractory follicular lymphoma: a preliminary analysis on 590 patients
Session: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical
Presenter: Neil R. Michaud, director, translational medicine, Epizyme, Inc.
Abstract No.: PS1247
Date: Saturday, June 15, 2019; 5:30 – 7:00 p.m. CEST
Location: Poster Area
ICML Oral Presentation
Title: Interim update from a Phase 2 multicenter study of tazemetostat, an EZH2 inhibitor, in patients with relapsed or refractory follicular lymphoma
Presenter: Franck Morschhauser, M.D., Ph.D., Centre Hospitalier Régional Universitaire de Lille, France
Abstract No.: 105
Date: Friday, June 21, 2019; 2:45 – 3:00 p.m. CEST
Location: Room A
About Epizyme, Inc.
Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company also is developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease. By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them. For more information, visit www.epizyme.com.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation of future clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; whether results from clinical studies will warrant meetings with regulatory authorities, submissions for regulatory approval or review by governmental authorities under the accelerated approval process; whether Fast Track Designation and Orphan Drug Designations will provide the benefits for which tazemetostat is eligible; expectations for regulatory approvals, including accelerated approval, to conduct trials or to market products; whether the company's cash resources will be sufficient to fund the company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the company's therapeutic candidates; and other factors discussed in the "Risk Factors" section of the company's most recent Form 10-Q filed with the SEC and in the company's other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date hereof and should not be relied upon as representing the company's views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company's views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.