On May 16, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported 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 (Press release, Epizyme, MAY 16, 2019, View Source [SID1234536447]).
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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) (Free ASCO Whitepaper) 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) (Free EHA Whitepaper) 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
Location: E450
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