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Epizyme Announces New Tazemetostat Clinical Data to be Presented in Oral Sessions at Multiple Upcoming Medical Meetings

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
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

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.

Contacts

Media:
Erin Graves, (617) 500-0615
Epizyme, Inc.
[email protected]

Investors:
Monique
Allaire, (617) 895-9511
THRUST Strategic Communications
[email protected]

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