Epizyme, Inc.
Jun 26, 2017

Epizyme Expands Clinical Collaboration to Study Tazemetostat and TECENTRIQ® Combination in NSCLC

Tazemetostat and Atezolizumab to be Evaluated as New Combination in Study of Non-Small Cell Lung Cancer as Part of Genentech's MORPHEUS Cancer Immunotherapy Platform

Further Expands Tazemetostat Solid Tumor Program

CAMBRIDGE, Mass., June 26, 2017 (GLOBE NEWSWIRE) -- Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, today announced that it has expanded its clinical collaboration with Genentech, a member of the Roche Group. Under the new agreement, tazemetostat administered in combination with atezolizumab (TECENTRIQ®) will be evaluated in a Phase 1b/2 clinical study for the treatment of patients with relapsed/refractory metastatic non-small cell lung cancer (NSCLC). The study will be part of MORPHEUS, Genentech's open-label, multi-center, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations for metastatic NSCLC.

"The MORPHEUS clinical platform is aimed at rapidly evaluating new cancer immunotherapy combination treatment regimens in patients with metastatic NSCLC," said Scott Clarke, global head, Roche oncology partnering. "The goal of this collaboration is to assess the role this combination therapy may play in immune-cell priming, activation and T-cell infiltration, potentially enhancing an anti-cancer response."

"A key part of Epizyme's long-term vision is expanding the benefit that tazemetostat can bring to a broad range of patients, which includes evaluating tazemetostat in combination with a variety of anti-cancer agents, such as checkpoint inhibitors," said Robert Bazemore, president and chief executive officer of Epizyme. "NSCLC is a devastating form of lung cancer affecting nearly 200,000 people in the U.S. and major European countries. This study marks our second immuno-oncology combination with Genentech, and we look forward to working together to understand the benefit combination treatment with tazemetostat and atezolizumab may have for patients with this difficult cancer."

Genentech will sponsor the planned Phase 1b/2 clinical trial, which is expected to be initiated by the end of 2017. It is anticipated that the study will enroll up to 40 patients who have experienced disease progression during or following treatment with a platinum-containing chemotherapy regimen and a PD‑L1/PD-1 checkpoint inhibitor. Financial terms are not disclosed and Epizyme will retain global development and commercialization rights to tazemetostat.

Epizyme's original collaboration with Genentech was announced in June 2016 to evaluate tazemetostat and atezolizumab as a combination regimen in a Phase 1b clinical trial for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma. That combination study is ongoing and continuing to enroll patients.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for follicular lymphoma regardless of EZH2 mutation and for DLBCL with EZH2-activating mutations, as well as Orphan Drug designation for soft tissue sarcoma and malignant rhabdoid tumors.

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 and in relapsed and front-line disease. Using the Company's proprietary platform, Epizyme has pioneered the identification and development of small molecule inhibitors of chromatin modifying proteins (CMPs), such as tazemetostat. 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, which can allow cancer cells to grow and proliferate. By focusing on the genetic drivers of cancers, Epizyme's science seeks to match targeted medicines with the specific patients that need it. For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.

TECENTRIQ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

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 results from preclinical studies or earlier clinical studies will be predictive of the results of future studies; whether interim data from clinical studies will be indicative of the final results of the study; whether results from clinical studies will warrant meetings with regulatory authorities or submissions for regulatory approval; whether submissions for regulatory approval will be made when anticipated or at all and whether these submissions will be reviewed under the accelerated approval framework; whether the Company will receive regulatory approvals to conduct trials or to market products; whether the Company's collaborations such as the collaboration with Genentech reported in this release will be successful; 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

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Source: Epizyme, Inc.

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