FDA Grants Tazemetostat Fast Track Designation
for DLBCL with EZH2 Activating Mutations
Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical
company creating novel epigenetic therapies, today announced
advancements in the Company’s clinical programs evaluating
tazemetostat, its first-in-class EZH2 inhibitor. The U.S. Food and
Drug Administration (FDA) has granted tazemetostat Fast Track
designation in patients with diffuse large B-cell lymphoma (DLBCL)
with EZH2 activating mutations. Additionally, Epizyme is focusing
its Phase 2 registration-enabling study in adult patients with
genetically-defined solid tumors on those cancers marked by loss of
INI1, and has expanded enrollment in the epithelioid sarcoma cohort
of the study based on encouraging early activity in this patient
population.
“We are very proud of the continued advancement of our
tazemetostat clinical program in both non-Hodgkin lymphoma and
genetically-defined solid tumors, important areas of unmet medical
need for patients with cancer,” said Robert Bazemore, president and
chief executive officer, Epizyme. “These developments reflect the
execution of our strategy to identify the patient groups who may
benefit most from tazemetostat, and our efforts to bring this
investigational medicine to patients as quickly as possible.”
NHL Program Update: Fast Track Designation for DLBCL
SubtypeThe FDA has granted Fast Track designation for the
investigation of tazemetostat for the treatment of patients with
relapsed or refractory DLBCL whose tumors carry an EZH2 activating
mutation. Tazemetostat inhibits EZH2, a histone methyltransferase
that is increasingly understood to play a role in the growth and
proliferation of a number of cancers, including DLBCL, the most
commonly diagnosed form of NHL.
The FDA Fast Track program is designed to facilitate the
development of important new drugs and to provide patients access
to those drugs more quickly. The designation enables early and
frequent communication between FDA and a product sponsor throughout
the drug development and review process. Through the Fast Track
program, a product may be eligible for priority review at the time
of a new drug application (NDA) filing and may also be eligible to
submit completed sections of the NDA on a rolling basis before the
complete application is submitted. These expedited processes can
potentially reduce development time and cost associated with
bringing a drug to market.
Genetically Defined Solid Tumor Program Update: Focus on
INI1-Negative TumorsFollowing review by the Independent
Data Monitoring Committee, Epizyme has expanded the epithelioid
sarcoma cohort of its ongoing Phase 2 trial in adult patients with
INI1-negative solid tumors. This expansion is based on encouraging
early activity seen, including confirmed objective responses, in
the cohort. The company plans to enroll an additional 30 patients
with epithelioid sarcoma, bringing the cohort to a total of 60
patients. This study represents the largest trial conducted to date
in this rare tumor type. Epithelioid sarcoma is a soft tissue
sarcoma characterized by loss of INI1. There are currently no
approved systemic therapies for the treatment of patients with
epithelioid sarcoma, and outcomes are extremely poor.
The synovial sarcoma arm of the Phase 2 trial has been fully
enrolled. Although some patients remain on treatment, Epizyme has
concluded that the activity of tazemetostat in this cohort is
insufficient to continue further investigation of tazemetostat as a
monotherapy. Unlike the cancers in the other four arms of the
study, synovial sarcoma is characterized by a functional
dysregulation of INI1, rather than by a complete loss of INI1.
Epizyme is now focusing its efforts on the four cohorts of
INI1-negative tumors in its study, including the epithelioid
sarcoma cohort. Enrollment continues in these cohorts and Epizyme
plans to present data from the Phase 2 trial in the first half of
2017.
“The early clinical activity observed in the epithelioid sarcoma
arm provides encouraging evidence of the effectiveness of EZH2
inhibition with tazemetostat in patients with INI1-negative
tumors,” added Peter Ho., M.D., Ph.D., chief medical officer,
Epizyme. “The clinical experience observed so far in both the
epithelioid sarcoma and synovial sarcoma cohorts is consistent with
our Phase 1 experience for these cancers. We look forward to
assessing clinical activity in the Phase 2 study and reporting data
in the first half of 2017.”
About the Tazemetostat Clinical Program
Tazemetostat, a first-in-class EZH2 inhibitor, is being evaluated
as a monotherapy and in combination with other agents in multiple
cancer indications. Phase 2 studies of tazemetostat as a
monotherapy are currently ongoing in patients with non-Hodgkin
lymphoma; in adults with INI1-negative tumors and children with
certain genetically defined solid tumors, including INI1-negative
tumors and synovial sarcoma; and in patients with mesothelioma
characterized by BAP1 loss-of-function.
Additionally, tazemetostat is being evaluated in two combination
studies in patients with DLBCL. A Phase 1b/2 trial of tazemetostat
in combination with R-CHOP, an immuno-chemotherapy regimen
consisting of rituximab, cyclophosphamide, doxorubicin, vincristine
and prednisone, is being conducted as a front-line treatment for
patients with DLBCL as part of Epizyme’s collaboration with the
Lymphoma Study Association. A Phase 1b study evaluating
tazemetostat in combination with Tecentriq® (atezolizumab), an
anti-PD-L1 cancer immunotherapy approved by the U.S. Food and Drug
Administration, is being conducted as part of a collaboration with
Genentech, a member of the Roche Group, in relapsed and refractory
patients with DLBCL. For more information on tazemetostat clinical
trials, please visit www.epizymeclinicaltrials.com.
About Epizyme, Inc. Epizyme, Inc. is a clinical
stage biopharmaceutical company creating novel epigenetic
therapeutics for cancer patients. Epizyme has built a proprietary
product platform that the Company uses to create small molecule
inhibitors of a 96-member class of enzymes known as histone
methyltransferases, or HMTs. HMTs are part of the system of gene
regulation, referred to as epigenetics, that controls gene
expression. Genetic alterations can result in changes to the
activity of HMTs, making them oncogenic (cancer-causing). By
focusing on the genetic drivers of cancers, Epizyme's targeted
science seeks to match the right medicines with the right patients.
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 such as the
early data referenced in this release 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 or submissions
for regulatory approval; whether a fast track designation will lead
to a faster development or regulatory review or approval process;
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.
Tecentriq™ is a trademark of Genentech, Inc., (South San
Francisco, CA, USA), a member of the Roche Group.
Media Contact:
Julie DiCarlo, Epizyme, Inc.
(617) 306-5823
jdicarlo@epizyme.com
Investor Contact:
Monique Allaire, THRUST Investor Relations
(617) 895-9511
monique@thrustir.com
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