- U.S. study sites now enrolling adults in registration-supporting phase
2 study - U.S. study sites now enrolling pediatric patients in phase 1 dose
escalation study
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company
creating novel epigenetic therapies for cancer patients, announced today
that the first patient has been dosed in the phase 2 study of
tazemetostat in adult patients with genetically defined tumors. The
phase 1 dose escalation study in pediatric patients with the same tumor
types is also now open for enrollment. The cancers being studied in
these trials, INI1-negative tumors, certain SMARCA4-negative tumors and
synovial sarcomas, are aggressive cancers that are poorly served by
current treatments. The first sites activated for adult enrollment are
Northwestern University, MD Anderson Cancer Center and Cincinnati
Children’s Hospital and the first sites activated for pediatric
enrollment are the Dana Farber Cancer Institute and Cincinnati
Children’s Hospital. Additional study sites in the U.S., Canada, Europe
and Australia are planned to be added over the upcoming months.
“Life-threatening rare tumors such as rhabdoid tumors, epithelioid
sarcomas and synovial sarcomas affect children and young adults who are
in need of novel effective therapies since the standard approaches are
only marginally useful,” said George Demetri, M.D., Director, Center for
Sarcoma and Bone Oncology, Dana-Farber Cancer Institute and Professor of
Medicine, Harvard Medical School. “We are enthusiastic about evaluating
tazemetostat in our patients with these forms of sarcomas since the
molecular mechanism is so compelling, especially with the recent
identification of mutations in INI1 or SMARCA4 as genetic drivers for
these cancers.”
“This important study will enroll children with cancers such as
malignant rhabdoid tumor, based on unique genetic defects that appear to
result in biological sensitivity to EZH2 inhibition,” said Susan Chi,
M.D., Director of the Pediatric Brain Tumor Clinical Trials Program,
Dana-Farber Cancer Institute and Assistant Professor of Pediatrics,
Harvard Medical School. “For children with these deadly diseases,
tazemetostat potentially represents a meaningful option when other
treatments have been exhausted.”
“Initiation of the clinical program in genetically defined solid tumors
is an important milestone for Epizyme and expands tazemetostat
development beyond non-Hodgkin lymphoma,” said Peter Ho, M.D., Ph.D.,
Chief Medical Officer, Epizyme. “We are excited to advance the study of
tazemetostat in these patients.”
The adult phase 2 multicenter study will enroll up to 90 patients in
three cohorts. The first cohort will be comprised of patients with
malignant rhabdoid tumor, rhabdoid tumor of the kidney and atypical
teratoid rhabdoid tumor, all of which are characterized by INI1- or
SMARCA4-negativity. The second cohort will be comprised of patients with
non-rhabdoid INI1-negative tumors including epithelial sarcoma,
epithelioid malignant peripheral nerve sheath tumor, extraskeletal
myxoid chondrosarcoma, myoepithelial carcinoma and renal medullary
carcinoma. The third cohort will be comprised of patients with synovial
sarcoma in which INI1 is dysregulated by a reciprocal translocation
between chromosome 18 and the X chromosome. Patients will be dosed at
800 mg twice daily with tablets taken orally. The primary endpoint is
overall response rate (ORR) for patients with INI1-negative tumors and
progression-free survival (PFS) for patients with synovial sarcoma.
Secondary endpoints include duration of response, overall survival (OS),
and PFS for patients with INI1-negative tumors, as well as safety and
pharmacokinetics (PK).
The pediatric phase 1 multicenter study will enroll approximately 40
patients in a dose escalation design, followed by dose expansion, with
an oral suspension of tazemetostat. The study will enroll patients with
the same INI1-negative tumors, SMARCA4-negative tumors or synovial
sarcoma as in the adult study. The primary endpoint of the study is
safety, with the objective of establishing the recommended phase 2 dose
in pediatric patients. Secondary endpoints include pharmacokinetics,
objective response rate, duration of response, progression free
survival, and overall survival.
INI1-negative or certain SMARCA4-negative tumors are characterized as
aggressive cancers with few to no approved treatments today. For
example, current treatment of malignant rhabdoid tumors, an
INI1-negative tumor, consists of surgery, chemotherapy and radiation
therapy, which are associated with limited efficacy and significant
treatment-related morbidity. In August, the FDA’s Division of Oncology
Products 2 accepted Epizyme’s IND application to study adult and
pediatric patients with INI1-negative solid tumors or synovial sarcoma
in the U.S.
Interim data from Epizyme’s phase 2 study of tazemetostat in adult
patients with genetically defined solid tumors are anticipated to be
presented at a medical conference in late 2016.
About EZH2 in Cancer
EZH2 is a histone methyltransferase (HMT) that is increasingly
understood to play a potentially oncogenic role in a number of cancers.
These include non-Hodgkin lymphoma, INI1-negative or certain
SMARCA4-negative cancers such as malignant rhabdoid tumors and
epithelioid sarcomas, synovial sarcoma, and a range of other solid
tumors.
About Tazemetostat
Epizyme is developing tazemetostat for the treatment of patients with
non-Hodgkin lymphoma and for patients with INI1-deficient solid tumors.
Tazemetostat is a first-in-class small molecule inhibitor of EZH2
created by Epizyme using its proprietary product platform. In some human
cancers, aberrant EZH2 enzyme activity results in misregulation of genes
that control cell proliferation resulting in the rapid and unconstrained
growth of tumor cells. Tazemetostat is the WHO International
Non-Proprietary Name (INN) for compound EPZ-6438.
Additional information about this program, including clinical trial
information for the adult five -arm NHL study, can be found here: https://clinicaltrials.gov/ct2/show/NCT01897571
Clinical trial information for the adult INI1-negative tumors, certain
SMARCA4-negative tumors or synovial sarcoma trial can be found here: https://clinicaltrials.gov/ct2/show/NCT02601950
Clinical trial information for the pediatric INI1-negative tumors,
certain SMARCA4-negative tumors or synovial sarcoma trial can be found
here: https://clinicaltrials.gov/ct2/show/NCT02601937
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 chromatin modifying proteins (CMPs), such as
histone methyltransferases or HMTs. CMPs 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 CMPs,
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
and connect with us on Twitter at @EpizymeRx.
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 or expansion of ongoing clinical
studies; availability and timing of data from ongoing clinical studies;
whether interim results from a clinical trial such as the results
referred to in this release will be predictive of the final results of
the trial or the results of future trials; expectations for regulatory
approvals to conduct trials or to market products; development progress
of the Company’s companion diagnostics, availability of funding
sufficient for 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 or companion diagnostics; and other factors
discussed in the “Risk Factors” section of the company’s Form 10-Q filed
with the SEC on November 9, 2015, and in our 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. 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.
These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the date
hereof.
Contacts
Epizyme, Inc.
Andrew Singer, 617-500-0712
Executive Vice
President and Chief Financial Officer
asinger@epizyme.com
or
Media/Investors:
THRUST
Investor Relations
Monique Allaire, 617-895-9511
monique@thrustir.com
