Company to Host Investor Conference Call on
October 22, 2018 at 8:30 am EDT
Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company
developing novel epigenetic therapies, announced today that updated
efficacy and safety data from the fully enrolled cohort of
epithelioid sarcoma (ES) patients in its ongoing Phase 2 trial of
tazemetostat will be presented in a poster discussion session at
the European Society for Medical Oncology (ESMO) 2018 Congress to
be held October 19-23 in Munich, Germany. Tazemetostat is the
company’s potent, selective, orally available, first-in-class EZH2
inhibitor.
The Phase 2 study ES cohort completed enrollment in 2017 with a
total of 62 patients. Detailed data will be presented at the
Congress, including objective response rate (ORR), the study’s
primary endpoint, and other important endpoints in this disease
including duration of response, overall survival (OS), disease
control rate and safety. For the first time, an analysis of ORR,
durability and OS will be presented in both treatment-naive
patients and in relapsed and/or refractory patients from the fully
enrolled study cohort. Data will be presented by the study’s
primary investigator, Mrinal Gounder, M.D., attending physician,
Sarcoma Medical Oncology and Early Drug Development Service, and
assistant professor, Memorial Sloan Kettering Cancer Center.
“We are excited to share these updated efficacy and safety data
on tazemetostat in patients with epithelioid sarcoma, a rare and
deadly cancer,” said Robert Bazemore, president and chief executive
officer of Epizyme. “We remain committed to bringing this potential
therapy to patients living with ES, and are confident as we
progress towards our first NDA submission in the first half of
2019.”
In addition to the ES data, Epizyme will present data from the
company’s Phase 2 study of tazemetostat in adult patients with
INI1-negative tumors in two additional poster discussions and
during one oral session at ESMO. A complete list of the
tazemetostat presentations at ESMO are listed below:
Epithelioid Sarcoma Poster Discussion SessionTitle: A
phase 2, multicenter study of the EZH2 inhibitor tazemetostat in
adults: (epithelioid sarcoma cohort)Abstract No.: 1615PDDate:
Monday, October 22, 2018; 11:50 a.m. CESTLocation: Hall B3 - Room
23Presenter: Mrinal Gounder, M.D.
Proffered Paper (Oral Presentation) SessionTitle:
Molecular characterization of epithelioid sarcoma (ES) tumors
derived from patients enrolled in a phase 2 study of
tazemetostatAbstract No.: 1892ODate: Saturday, October 20, 2018;
11:12 a.m. – 11:24 a.m. CESTLocation: Hall B3 - Room 21Presenter:
Mrinal Gounder, M.D.
Poster Discussion SessionsTitle: A phase 2, multicenter
study of the EZH2 inhibitor tazemetostat in adults (INI1-negative
tumors cohort)Abstract No.: 1611PDDate: Monday, October 22, 2018;
11:50 a.m. CESTLocation: Hall B3 - Room 23Presenter: Silvia
Stacchiotti, M.D.
Title: A phase 2, multicenter study of the EZH2 inhibitor
tazemetostat in adults (rhabdoid tumor cohort)Abstract No.:
1612PDDate: Monday, October 22, 2018; 11:50 a.m. CESTLocation: Hall
B3 - Room 23Presenter: Robin L. Jones, MRCP, M.D.
Conference Call InformationEpizyme Management will host a
conference call on Monday, October 22, 2018 at 8:30am EDT. To
participate in the conference call, please dial 877-844-6886
(domestic) or 970-315-0315 (international) and refer to conference
ID 8780088. The webcast can be accessed in the Investor Relations
section of the company's website at www.epizyme.com. The replay of
the webcast will be available in the investor section of the
company’s website for 60 days.
About the Tazemetostat Clinical Trial
ProgramTazemetostat, 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 also is 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20181010005229/en/
Media:Erin Graves, 617-500-0615Epizyme,
Inc.media@epizyme.comorInvestors:Monique Allaire,
617-895-9511THRUST Strategic Communicationsmonique@thrustsc.com
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