Industry Press Releases

Epizyme announces FDA Acceptance of Investigational New Drug Application for Tazemetostat in Diffuse Large B-cell Lymphoma

Tuesday, Dec 29, 2015
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Epizyme, Inc., a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, today announced the U.S. Food and Drug Administration’s (FDA) Division of Hematology Products has accepted the company’s investigational new drug (IND) application for tazemetostat for the treatment of adults with diffuse large B-cell lymphoma (DLBCL), the most common type of Non-Hodgkin Lymphoma (NHL). An ongoing five-arm registration-supporting, international phase 2 clinical trial assessing the safety and activity of tazemetostat in patients with relapsed or refractory B-cell NHL was initiated in July 2015. The IND acceptance will allow the company to enroll DLBCL patients in the United States into this ongoing trial.

“Tazemetostat has demonstrated clinically meaningful anti-tumor activity and an acceptable safety profile in patients with NHL in our phase 1 study,” said Robert Bazemore, President and Chief Executive Officer. “We are excited to enable U.S. investigators to gain experience with tazemetostat in DLBCL.”

“Patients with relapsed or refractory NHL have a significant need for new treatment options,” said Dr. Peter Ho, M.D., Ph.D., Chief Medical Officer, Epizyme. “We believe tazemetostat has the potential to become an important therapy for B-cell NHL patients, both as a monotherapy and in combination, and look forward to extending the ongoing five-arm NHL study to allow access to DLBCL patients in the U.S.”

About the Tazemetostat Clinical Trial Program

The phase 2 NHL trial is a five-arm, multi-center, international study that will use a two-stage design to assess the safety and activity of tazemetostat in multiple populations of patients with relapsed or refractory Non-Hodgkin Lymphoma. The study will enroll up to 30 patients in each arm. Patients will be prospectively stratified for EZH2 mutation status and cell-of-origin. The five study arms are enrolling relapsed/refractory patients with:

    Germinal center DLBCL with mutant EZH2
    Germinal center DLBCL with wild-type EZH2
    Non-germinal center DLBCL
    Follicular lymphoma with mutant EZH2
    Follicular lymphoma with wild-type EZH2

Epizyme expects to present interim data from the phase 2 study in NHL at a medical conference in mid-2016.

In the first half of 2016, the Company also plans to initiate additional clinical evaluations of tazemetostat, including a combination study with R-CHOP in front-line, high-risk patients with DLBCL, and a combination study with a B-cell signaling agent or immuno-oncology agent in B-cell NHL.

In August 2015, 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.

About Tazemetostat

Epizyme is developing tazemetostat for the treatment of patients with Non-Hodgkin Lymphoma and for patients with INI1-negative solid tumors, certain SMARCA4-negative solid tumors or synovial sarcoma. 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

Information about the company’s Phase 2 clinical trial of tazemetostat in adults with INI1-negative solid tumors, certain SMARCA4-negative solid tumors or synovial sarcoma can be found here: https://clinicaltrials.gov/ct2/show/NCT02601950

Information about the company’s Phase 1 clinical trial of tazemetostat in children with INI1-negative solid tumors, certain SMARCA4-negative solid tumors or synovial sarcoma 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

Media/Investors:
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

 

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