Epizyme Presents New Biomarker Data on Tazemetostat at the American Society of Hematology Annual Meeting
December 10 2017 - 10:00AM
Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical
company developing novel epigenetic therapies, today announced that
two presentations reinforcing its commitment to identifying
predictors of response to tazemetostat beyond EZH2 mutations will
be featured at the 59th Annual Meeting & Exposition of the
American Society of Hematology (ASH) in Atlanta, Ga.
These data from the company's ongoing Phase 2 clinical trial in
non-Hodgkin lymphoma (NHL) highlight exploratory response
biomarkers and interim correlative data which may have the
potential to further refine the clinical application of
tazemetostat. Tazemetostat is a potent, selective, orally available
inhibitor of EZH2 and is currently in Phase 2 development for the
treatment of patients with follicular lymphoma (FL) or diffuse
large B-cell lymphoma (DLBCL), both of which are subtypes of
NHL.
The first poster (#2745), Response to the EZH2 Inhibitor
Tazemetostat is Independent of Cell of Origin Determined Via Hans
Immunohistochemistry or Nanostring Lymphoma Subtyping Test in EZH2
Wild-Type DLBCL Patients, will be presented by Alice McDonald,
associate director, translational medicine, Epizyme, on Sunday,
Dec. 10, 2017 at 6:00 p.m. ET.
The second poster (#4013), Discovery of Candidate Predictors of
Response to Tazemetostat in Diffuse Large B-Cell Lymphoma and
Follicular Lymphoma using NGS Technology on ctDNA Samples Collected
Pre-Treatment, will be presented by Scott Daigle, principal
scientist, translational medicine, Epizyme, on Monday, Dec. 11,
2017 at 6:00 p.m. ET.
About Follicular Lymphoma (FL)FL is considered
to be incurable with existing treatments and is characterized by
cycles of relapse that become increasingly difficult to treat with
each disease progression. It is estimated that approximately 40,000
FL patients in the United States and major European countries alone
are treated with systemic therapies each year, of which an
estimated 20 percent have an EZH2-activating mutation. There are no
approved treatments indicated for patients with FL with an EZH2
mutation.
About Diffuse Large B-Cell Lymphoma
(DLBCL)DLBCL is an aggressive form of NHL that, once
diagnosed, typically requires immediate treatment. It is estimated
that approximately 80,000 patients in the United States and major
European countries alone are actively treated with systemic
therapies to manage their disease every year. Approximately 40
percent of DLBCL patients are diagnosed with germinal center
lymphoma and an estimated 20 percent of those patients have an
EZH2-activating mutation. Forty to 50 percent of patients will
relapse on their first-line treatment, which is most commonly the
chemotherapy regimen R-CHOP, and there are few treatment options
for patients who relapse or become refractory to chemotherapy.
There are no approved treatments indicated for patients with DLBCL
with an EZH2 mutation.
About the Tazemetostat Clinical Trial
ProgramTazemetostat, a first-in-class EZH2 inhibitor, is
currently being studied in ongoing Phase 2 monotherapy programs in
both FL and DLBCL forms of NHL; certain molecularly defined solid
tumors, including epithelioid sarcoma and other INI1-negative
tumors; and mesothelioma; as well as in combination studies in
DLBCL and non-small cell lung cancer (NSCLC). Tazemetostat has been
granted Fast Track Designation by the U.S. Food and Drug
Administration for FL regardless of EZH2 mutation and for DLBCL
with EZH2-activating mutations. The FDA has also granted
tazemetostat Orphan Drug Designation for FL, malignant rhabdoid
tumors, soft tissue sarcoma and mesothelioma.
About Epizyme, Inc. Epizyme, Inc. is a
clinical-stage biopharmaceutical company committed to rewriting
cancer treatment 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. By focusing
on the genetic drivers of cancers, Epizyme's science seeks to match
targeted medicines with 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 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:Cheya Pope, Epizyme,
Inc.media@epizyme.com 617-229-7561
Monique Allaire, THRUST IRmonique@thrustir.com 617-895-9511
Epizyme (NASDAQ:EPZM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Epizyme (NASDAQ:EPZM)
Historical Stock Chart
From Sep 2023 to Sep 2024