CAMBRIDGE, Mass.--(BUSINESS WIRE)--Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage company developing novel epigenetic therapies, today announced the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials. Epizyme is now in the process of reopening enrollment in all of its company-sponsored trials in the U.S., including the follicular lymphoma (FL) EZH2 activating mutation cohort of its Phase 2 non-Hodgkin lymphoma trial.
Epizyme’s formal response to the FDA included a comprehensive assessment of the risk of secondary malignancies, including T-cell lymphoblastic lymphoma (T-LBL) potentially associated with tazemetostat, which took into account both published literature and the company’s clinical experience to date. This followed a report of a single case of T-LBL in its tazemetostat pediatric study. Epizyme provided a thorough assessment of efficacy and safety data across all of its trials in hematological malignancies and solid tumors, in both adults and children, and convened a panel of external scientific and medical experts who reviewed and validated the findings.
“The Epizyme team has worked diligently to provide a comprehensive response back to the FDA, and through constructive dialogue, we successfully resolved the partial clinical hold. This allows us to turn our full attention to our key priorities: preparing for our first NDA submission for tazemetostat in epithelioid sarcoma and defining our registration path in FL,” said Robert Bazemore, president and chief executive officer of Epizyme. “We, along with our investigators and the global experts we consulted to support our complete response, continue to believe in the positive benefit/risk of tazemetostat as we move forward in our clinical development program. We remain steadfast in our commitment to bringing this potential therapeutic option to cancer patients in need of safe and effective new treatments.”
Epizyme will now engage with regulators in France and Germany to resolve the partial clinical holds and resume enrollment in those countries. The company is also working closely with its study partners to reach a similar resolution for their respective trials in which tazemetostat is being studied in combination with other therapies.
Investor Conference Call Notice
Company
management plans to host a conference call and webcast at 8:30 a.m. EDT
today to discuss the resolution of the partial clinical hold. To
participate, please dial (877) 844-6886 (domestic) or (970) 315-0315
(international) and refer to conference ID 3499753. A live webcast will
be available in the investor section of the company’s website at www.epizyme.com.
The webcast also will be archived on the website for 60 days.
About the Tazemetostat Clinical Trial Program
Tazemetostat,
a potent, selective, orally available, first-in-class EZH2 inhibitor, is
currently being studied as a monotherapy in ongoing Phase 2 programs in
certain molecularly defined solid tumors, including epithelioid sarcoma
and other INI1-negative tumors; follicular lymphoma (FL); and
combination studies in diffuse large B-cell lymphoma (DLBCL) and
non–small cell lung cancer (NSCLC).
About Epizyme, Inc.
Epizyme,
Inc. is a clinical-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 is also 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 relating to the
Company’s ability to resume enrollment in its tazemetostat trials and
the timing of such resumption, and the impact of the safety finding on
enrollment of patients in ongoing and future trials of tazemetostat
following the lifting of the partial clinical hold and the resumption of
enrollment; 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.
