Epizyme Initiates Collaboration on Combination Trial of Tazemetostat and Tecentriq™ (atezolizumab) for Treatment of Non-Hodgkin Lymphoma

Clinical trial to evaluate Epizyme’s clinical-stage EZH2 inhibitor in combination with anti-PD-L1 cancer immunotherapy

CAMBRIDGE, Mass.--()--Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, announced today it has entered into a collaboration agreement with Genentech, a member of the Roche Group, to conduct a clinical trial to investigate the anti-cancer effects of Epizyme’s EZH2 inhibitor, tazemetostat, and Genentech’s recently approved anti-PD-L1 cancer immunotherapy, Tecentriq™ (atezolizumab), when used in combination. The study will evaluate this combination regimen for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma.

“We believe this study will be enhanced by our partner’s deep expertise in the field of immuno-oncology. This collaboration aligns us with a global leader in oncology and hematology, and advances Epizyme’s leadership position in the development of epigenetic therapeutics.”

“A key part of Epizyme’s long-term vision is expanding the benefit that tazemetostat can bring to patients, and includes combining tazemetostat with checkpoint inhibitors,” said Robert Bazemore, President and Chief Executive Officer, Epizyme. “We believe this study will be enhanced by our partner’s deep expertise in the field of immuno-oncology. This collaboration aligns us with a global leader in oncology and hematology, and advances Epizyme’s leadership position in the development of epigenetic therapeutics.”

Under the agreement, Genentech will manage study operations for the planned clinical trial. The planned phase 1b clinical trial is expected to begin enrolling patients in the second half of 2016.

“The goal of this collaboration is to generate clinical proof-of-concept for the combination, building on tazemetostat’s activity as a monotherapy in a Phase 1 study of NHL and preclinical observations that EZH2 inhibition may have a priming effect on the immune system and improve the activity of checkpoint inhibitors,” said Peter Ho, M.D., Ph.D., Chief Medical Officer, Epizyme. “We look forward to evaluating this combination in patients with DLBCL, and to exploring the potential to expand the therapeutic opportunities for tazemetostat, as well as Tecentriq.”

Tecentriq, the first and only anti-PD-L1 cancer immunotherapy approved by the U.S. Food and Drug Administration, recently received accelerated approval for people with a specific type of advanced bladder cancer.

About Tazemetostat
Epizyme is developing tazemetostat for the treatment of patients with non-Hodgkin lymphoma and patients with certain genetically defined 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 dysregulation 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 tazemetostat, including clinical trial information, can be found here.

About Epizyme, Inc.
Epizyme, Inc. is a clinical-stage biopharmaceutical company creating novel epigenetic therapeutics for people with cancer. Epizyme has built a proprietary product platform to create small molecule inhibitors of chromatin modifying proteins (CMPs), such as histone methyltransferases (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.

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," "plans," "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, 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 or the results of future trials, expectations for regulatory approvals, whether the Company’s collaborations such as its collaboration with Roche will be successful, 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 our Form 10-Q most recently filed with the SEC, 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.

Tecentriq™ is a trademark of Genentech, Inc., (South San Francisco, CA, USA), a member of the Roche Group.

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Epizyme, Inc.