These data from the company’s ongoing Phase 2 clinical trial in non-Hodgkin lymphoma (NHL) highlight exploratory response biomarkers and interim correlative data which may have the potential to further refine the clinical application of tazemetostat.
CAMBRIDGE, Mass., Dec. 10, 2017 (GLOBE NEWSWIRE) -- Epizyme (NASDAQ:EPZM), a clinical-stage biopharmaceutical company developing novel epigenetic therapies, today announced that two presentations reinforcing its commitment to identifying predictors of response to tazemetostat beyond EZH2 mutations will be featured at the 59th Annual Meeting & Exposition of the American Society of Hematology (ASH) in Atlanta, Ga.
These data from the company’s ongoing Phase 2 clinical trial in non-Hodgkin lymphoma (NHL) highlight exploratory response biomarkers and interim correlative data which may have the potential to further refine the clinical application of tazemetostat. Tazemetostat is a potent, selective, orally available inhibitor of EZH2 and is currently in Phase 2 development for the treatment of patients with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), both of which are subtypes of NHL.
The first poster (#2745), Response to the EZH2 Inhibitor Tazemetostat is Independent of Cell of Origin Determined Via Hans Immunohistochemistry or Nanostring Lymphoma Subtyping Test in EZH2 Wild-Type DLBCL Patients, will be presented by Alice McDonald, associate director, translational medicine, Epizyme, on Sunday, Dec. 10, 2017 at 6:00 p.m. ET.
The second poster (#4013), Discovery of Candidate Predictors of Response to Tazemetostat in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma using NGS Technology on ctDNA Samples Collected Pre-Treatment, will be presented by Scott Daigle, principal scientist, translational medicine, Epizyme, on Monday, Dec. 11, 2017 at 6:00 p.m. ET.
About Follicular Lymphoma (FL)
FL is considered to be incurable with existing treatments and is characterized by cycles of relapse that become increasingly difficult to treat with each disease progression. It is estimated that approximately 40,000 FL patients in the United States and major European countries alone are treated with systemic therapies each year, of which an estimated 20 percent have an EZH2-activating mutation. There are no approved treatments indicated for patients with FL with an EZH2 mutation.
About Diffuse Large B-Cell Lymphoma (DLBCL)
DLBCL is an aggressive form of NHL that, once diagnosed, typically requires immediate treatment. It is estimated that approximately 80,000 patients in the United States and major European countries alone are actively treated with systemic therapies to manage their disease every year. Approximately 40 percent of DLBCL patients are diagnosed with germinal center lymphoma and an estimated 20 percent of those patients have an EZH2-activating mutation. Forty to 50 percent of patients will relapse on their first-line treatment, which is most commonly the chemotherapy regimen R-CHOP, and there are few treatment options for patients who relapse or become refractory to chemotherapy. There are no approved treatments indicated for patients with DLBCL with an EZH2 mutation.
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 monotherapy programs in both FL and DLBCL forms of NHL; certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma; as well as in combination studies in DLBCL and non-small cell lung cancer (NSCLC). Tazemetostat has been granted Fast Track Designation by the U.S. Food and Drug Administration for FL regardless of EZH2 mutation and for DLBCL with EZH2-activating mutations. The FDA has also granted tazemetostat Orphan Drug Designation for FL, malignant rhabdoid tumors, soft tissue sarcoma and mesothelioma.
About Epizyme, Inc.
Epizyme, Inc. is a clinical-stage biopharmaceutical company committed to rewriting cancer treatment 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. By focusing on the genetic drivers of cancers, Epizyme’s science seeks to match targeted medicines with 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 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:
Cheya Pope, Epizyme, Inc.
media@epizyme.com
617-229-7561
Monique Allaire, THRUST IR
monique@thrustir.com
617-895-9511
