Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies against novel epigenetic targets, today announced that new data from across its oncology portfolio will be presented at the upcoming 63rd American Society of Hematology (ASH) Annual Meeting, taking place from December 11 to 14, 2021 in Atlanta, Georgia. These presentations include trial design and data from combination studies evaluating tazemetostat in follicular lymphoma, as well as new preclinical data on EZM0414, the Company’s novel, first-in-class, oral SETD2 inhibitor, an investigational agent being evaluated for the treatment of adult patients with relapsed or refractory multiple myeloma or with diffuse large B-cell lymphoma (DLBCL).

“We look forward to sharing the latest data from our growing oncology portfolio with the hematology community at this year’s meeting, including updated data from the Phase 1b portion of our Phase 1b/3 confirmatory study, SYMPHONY-1, which is evaluating the safety and optimal dose of tazemetostat plus Revlimid and Rituximab (R²). We will also be presenting preclinical data for EZM0414, our novel, first-in-class, oral SETD2 inhibitor development candidate; these data provided the rationale for our Phase 1/1b study with EZM0414, and we will be sharing the trial design in a “Trial-In-Progress” poster as well,” said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer. “These data will add to our knowledge of the important role epigenetics plays in B-cell malignancies, and we are excited about the potential that targeting epigenetic regulators may hold for patients living with blood cancers.”

Details of the poster presentations are listed below:

TAZEMETOSTAT

Tazemetostat is a first-in-class, oral, selective inhibitor of EZH2, which is an epigenetic regulator of B-cell identity and plays a role in both normal B-cell biology and the pathogenesis of follicular lymphoma. The interim data analysis being presented highlights the potential of tazemetostat as a backbone of combination therapies for patients living with follicular lymphoma, and includes updated safety run-in data from the Phase 1b portion of the confirmatory SYMPHONY-1 study, in addition to study follow-up on 40 patients treated with tazemetostat in combination with R². Additional presentations include trial design details of ongoing SYMPHONY-2, a Phase 2 study evaluating tazemetostat in combination with rituximab, as well as an analysis of the molecular and genetic characterization of patients treated with tazemetostat to better understand the drivers of response to treatment.

• Title: Interim Analysis of the Randomized Phase 1b/3 Study Evaluating the Safety and Efficacy of Tazemetostat Plus Lenalidomide and Rituximab in Patients with Relapsed/Refractory Follicular Lymphoma
  • Presenter: Connie Lee Batlevi MD, PhD, Medical Oncologist, Memorial Sloan Kettering Cancer Center
  • Abstract No: 2207
  • Date: Sunday, December 12, 2021, 6:00 PM-8:00 PM
  • Location: Hall B5 (Georgia World Congress Center)

• Title: Trial in Progress: A Phase 2, Single-Arm, Open-Label, Multicenter Study of Tazemetostat in Combination with Rituximab for the Treatment of Relapsed or Refractory Follicular Lymphoma
  • Presenter: Krish Patel, MD, Director of Lymphoma, Swedish Cancer Institute
  • Abstract No: 3541
  • Date: Monday, December 13, 2021: 6:00 PM-8:00 PM
  • Location: Hall B5 (Georgia World Congress Center)

• Title: Molecular and Genetic Characterization of Tumor Samples from Patients with Relapsed or Refractory Follicular Lymphoma Identifies Factors Influencing Response to Tazemetostat
  • Presenter: Sandeep Dave, MD, MS, Associate Professor, Division of Hematologic Malignancies & Cellular Therapy, Department of Medicine at Duke Cancer Institute
  • Abstract No: 1183
  • Date: Saturday, December 11, 2021: 5:30 PM-7:30 PM
  • Location: Hall B5 (Georgia World Congress Center)

EZM0414

SETD2 is a histone methyltransferase, similar to EZH2, which plays multiple important roles in oncogenesis. The preclinical data to be presented focus on the pharmacologic inhibition of SETD2 by investigational agent EZM0414, as a potential therapeutic strategy in multiple myeloma and DLBCL. These data provided the rationale for the SET-101 study, the first-in-human Phase 1/1b clinical trial designed to evaluate safety and determine the optimal dose of EZM0414. Following this dose-ranging phase, the study will be expanded to evaluate EZM0414 in three patient cohorts: t(4;14) multiple myeloma, non t(4;14) multiple myeloma, and DLBCL.

• Title: A Phase 1/1b Open-Label, Multicenter, Two-Part Study of SETD2 Inhibitor EZM0414 in Patients with Relapsed/Refractory Multiple Myeloma or Diffuse Large B-Cell Lymphoma
  • Presenter: Paul G. Richardson, MD, Medical Oncologist at Dana-Farber Cancer Institute
  • Abstract No: 1679
  • Date: Saturday, December 11, 2021: 5:30 PM to 7:30 PM ET
  • Location: Hall B5 (Georgia World Congress Center)

• Title: Pharmacologic Inhibition of the Histone Methyltransferase SETD2 with EZM0414 As a Novel Therapeutic Strategy in Relapsed or Refractory Multiple Myeloma and Diffuse Large B-Cell Lymphoma
  • Presenter: Jennifer Totman, Principal Scientist at Epizyme
  • Abstract No: 1142
  • Date: Saturday, December 11, 2021: 5:30 PM to 7:30 PM ET
  • Location: Hall B5 (Georgia World Congress Center)

Revlimid + Rituximab (R²) is a registered trademark of Celgene Corporation, a Bristol Myers Squibb company.

About Epizyme, Inc.

Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. The Company is focused on creating medicines that are targeted at specific causes of diseases, that are orally administered, tolerable, easy to take and based on a deep understanding of the patients that may benefit from them. The Company aspires to change the standard-of-care for patients and physicians by developing medicines with fundamentally new mechanisms of action. 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: whether commercial sales of TAZVERIK for epithelioid sarcoma and follicular lymphoma in the approved indications will be successful; whether the refinement of the company’s commercial strategy and cost reductions will achieve the company’s objectives; whether tazemetostat will receive marketing approval for epithelioid sarcoma or follicular lymphoma in other jurisdictions, full approval in the United States or approval in any other indication; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials, such as the ongoing confirmatory trials of TAZVERIK; 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 the company will receive regulatory approvals, including accelerated approval, to conduct trials or to market products; whether the company’s collaborations and licensing agreements with its partners, such as HUTCHMED or others, will be successful; the impact of the COVID-19 pandemic on the company’s business, results of operations and financial condition; 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 success of tazemetostat; and other factors discussed in the “Risk Factors” section of the company’s most recent Form 10-K or 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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