Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that multiple abstracts have been accepted for poster presentations during the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, being held May 29-31, 2020.
“We are pleased to participate in ASCO’s virtual program, reporting the pooled data from the two Phase 2 study cohorts of tazemetostat for epithelioid sarcoma, which supported the approval of TAZVERIK™ in January, as well as a presentation of the trial design for our ongoing confirmatory trial in epithelioid sarcoma,” said Dr. Shefali Agarwal. “We will also report the final data from our study of tazemetostat as a monotherapy for mesothelioma, originally presented at ASCO 2018, and early data from the Phase 1b portion of our trial of tazemetostat in pediatric patients with INI1-negative tumors. As we look ahead, 2020 is an important year for the commercialization of TAZVERIK, as well as advancing our tazemetostat clinical program in multiple additional cancer indications and combinations.”
All posters will be available online on May 29, 2020, and details of the abstracts are as follows:
Title: Efficacy, safety, and immune priming effect of tazemetostat in patients with epithelioid sarcoma
Authors: Mrinal M. Gounder, Silvia Stacchiotti, Patrick Schoffski, Gregory M. Cote, Victor M. Villalobos, Thierry M. Jahan, Tom Wei-Wu Chen, Ravin Ratan, Abha A. Gupta, Palma Dileo, Mark Agulnik, Antoine Italiano, Steven Attia, Olivier Mir, Joseph G. Pressey, Laura Sierra, Trupti Lingaraj, Jay Yang, Shefali Agarwal, Robin L. Jones
Title: A phase Ib/III randomized, double-blind, placebo-controlled study of tazemetostat plus doxorubicin as frontline therapy for patients with advanced epithelioid sarcoma
Authors: Shiraj Sen, Meredith A. McKean, Laura Sierra, Jessica Ainscough, Jay Yang, Anthony Hamlett, Tom Zimmerman, Melinda Merchant, Sant P. Chawla
Title: Phase I study of tazemetostat, an enhancer of zeste homolog-2 inhibitor, in pediatric patients with relapsed/refractory integrase interactor 1-negative tumors
Authors: Susan N. Chi, Franck Bourdeaut, Theodore W. Laetsch, Maryam Fouladi, Margaret E. Macy, Guy W. Makin, Neerav N. Shukla, Cynthia Wetmore, Ashley S. Margol, Michela Casanova, Lindsay B. Kilburn, Joanna Yi, Darren R. Hargrave, Geoffrey B. McCowage, Navin R. Pinto, David Ebb, Giles W. Robinson, Laura Sierra, Melinda Merchant, Karsten Nysom
Title: Safety and efficacy of tazemetostat, an enhancer of zeste-homolog 2 inhibitor, in patients with relapsed or refractory malignant mesothelioma
Authors: Marjorie G. Zauderer, Peter W. Szlosarek, Sylvestre Le Moulec, Sanjay Popat, Paul Taylor, David Planchard, Arnaud Scherpereel, Thierry M. Jahan, Marianna Koczywas, Martin Forster, Robert B. Cameron, Tobias Peikert, Evren K. Argon, Neil Michaud, Jay Yang, Vikram Kansra, Dean A. Fennell
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. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK™ (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. A supplemental New Drug Application is under Priority Review by the U.S. FDA for TAZVERIK for the treatment of patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy. The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. 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 tazemetostat will receive marketing approval for epithelioid sarcoma in other jurisdictions, full approval in the United States or approval in any other indication on a timely basis or at all, including approval of the company’s sNDA for FL; uncertainties related to the impact on the company’s business of the COVID-19 pandemic, including the commercial launch of TAZVERIK, ongoing and planned clinical trials and commercial and clinical supply of TAZVERIK; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials, such as the ongoing confirmatory 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; expectations for regulatory approvals, including accelerated approval, 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 success of tazemetostat or 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.
TAZVERIK™ is a trademark of Epizyme, Inc.
Erin Graves, Epizyme, Inc.