Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage company
developing novel epigenetic therapies, announced today its
first-in-human data on the effects of EZH2 inhibition in patients
with advanced solid tumors and B-cell non-Hodgkin lymphoma (NHL)
was published in the peer-reviewed The Lancet Oncology. The
objectives of the Phase 1 dose-escalation portion of the study were
to evaluate the safety and tolerability of orally dosed
tazemetostat, a first-in-class selective inhibitor of EZH2. The
study established the recommended dose for the Phase 2 expansion
study and demonstrated favorable safety findings and anti-tumor
activity.
“Today's publication in The Lancet Oncology reports the safety
and tolerability endpoints for tazemetostat in this study, which
enabled further evaluation of EZH2 inhibition in INI1- and
SMARCA4-negative solid tumors and NHL,” said Professor Antoine
Italiano, MD, Ph.D. of Institut Bergonie and lead author of the
paper. “I’m also encouraged by the preliminary anti-tumor activity
observed in this study.”
The open-label Phase 1 study was designed to evaluate the
maximally tolerated dose and supported defining the recommended
Phase 2 dose (RP2D) of tazemetostat. Tazemetostat was dosed twice
daily as a single agent in patients with relapsed or refractory
B-cell NHL (n=21) or with advanced solid tumors (n=43) including
molecularly defined INI1- or SMARCA4-negative tumors. Additional
study objectives were to evaluate the adverse events (AE),
pharmacokinetics (PK), pharmacodynamics (PD) and preliminary
anti-tumor activity of the agent.
The results of the safety, PK and PD analyses helped determine
the RP2D of 800 mg twice daily. The most common treatment-related
adverse events, regardless of attribution, were grade 1 or 2
asthenia, anorexia, anemia, muscle spasms, nausea and vomiting. One
single dose-limiting toxicity of grade 4 thrombocytopenia was
identified at the highest dose of 1600 mg, but no other grade 3 or
4 toxicities were observed at a frequency greater than five
percent.
Anti-tumor activity was seen across several tumor types. In
B-cell NHL, durable objective responses were observed in eight
patients. Three patients had a complete response (CR), one with
diffuse large B-cell lymphoma (DLBCL) and two with follicular
lymphoma (FL). Five additional patients experienced a partial
response (PR): three with DLBCL, one with FL and one with marginal
zone lymphoma.
Of the patients with solid tumors enrolled in this study, 13 had
INI1- or SMARCA4-negative tumors. Activity was observed in five of
these patients, including a CR in one patient with a malignant
rhabdoid tumor, and a PR in one patient with SMARCA4-negative
malignant rhabdoid tumor of the ovary (MRTO). Prolonged stable
disease was observed in a patient with MRTO and two patients with
epithelioid sarcoma (ES) experienced prolonged stable disease
greater than 20 months.
“We are excited to see these data published in The Lancet
Oncology, knowing that few Phase 1 studies are selected. We believe
this is an important confirmation of our science as we continue to
advance tazemetostat—a potent, selective, orally available EZH2
inhibitor," said Robert Bazemore, president and chief executive
officer of Epizyme. "Additionally, we would like to thank the
investigators, patients and caregivers for their participation in
this study, and for contributing to our understanding of
tazemetostat as we work to address a significant medical need.”
The results from this early phase study laid the groundwork for
further exploration of tazemetostat in larger trials as a targeted
approach to treat molecularly defined tumors predicted to be
dependent on EZH2 activity, such as ES and NHL. Phase 2 studies in
adults and a Phase 1 study for children, adolescents and young
adults are currently enrolling patients living with these types of
cancer.
The paper titled “Tazemetostat, an EZH2 inhibitor, in relapsed
or refractory B-cell non-Hodgkin lymphoma and advanced solid
tumours: a first-in-human, open-label, phase 1 study” was authored
by researchers from Institut Bergonié, Institut Gustave Roussy and
Université de Bordeaux, as well as members from Epizyme’s Research
and Clinical Development teams. The paper is available online today
by clicking here and will be published in the May issue,
available April 25, 2018.
About the Tazemetostat Clinical Trial
ProgramTazemetostat, a 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; both follicular
lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of
non-Hodgkin lymphoma (NHL); mesothelioma; and combination studies
in DLBCL and 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
StatementsAny 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:
Media:Cheya Pope, Epizyme, Inc.media@epizyme.com (617)
229-7561
Investors:Jason Fredette, Epizyme, Inc.
jfredette@epizyme.com (617) 500-0623
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