On October 10, 2018 Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, reported that updated efficacy and safety data from the fully enrolled cohort of epithelioid sarcoma (ES) patients in its ongoing Phase 2 trial of tazemetostat will be presented in a poster discussion session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress to be held October 19-23 in Munich, Germany (Press release, Epizyme, OCT 10, 2018, View Source [SID1234529845]). Tazemetostat is the company’s potent, selective, orally available, first-in-class EZH2 inhibitor.
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The Phase 2 study ES cohort completed enrollment in 2017 with a total of 62 patients. Detailed data will be presented at the Congress, including objective response rate (ORR), the study’s primary endpoint, and other important endpoints in this disease including duration of response, overall survival (OS), disease control rate and safety. For the first time, an analysis of ORR, durability and OS will be presented in both treatment-naive patients and in relapsed and/or refractory patients from the fully enrolled study cohort. Data will be presented by the study’s primary investigator, Mrinal Gounder, M.D., attending physician, Sarcoma Medical Oncology and Early Drug Development Service, and assistant professor, Memorial Sloan Kettering Cancer Center.
"We are excited to share these updated efficacy and safety data on tazemetostat in patients with epithelioid sarcoma, a rare and deadly cancer," said Robert Bazemore, president and chief executive officer of Epizyme. "We remain committed to bringing this potential therapy to patients living with ES, and are confident as we progress towards our first NDA submission in the first half of 2019."
In addition to the ES data, Epizyme will present data from the company’s Phase 2 study of tazemetostat in adult patients with INI1-negative tumors in two additional poster discussions and during one oral session at ESMO (Free ESMO Whitepaper). A complete list of the tazemetostat presentations at ESMO (Free ESMO Whitepaper) are listed below:
Epithelioid Sarcoma Poster Discussion Session
Title: A phase 2, multicenter study of the EZH2 inhibitor tazemetostat in adults: (epithelioid sarcoma cohort)
Abstract No.: 1615PD
Date: Monday, October 22, 2018; 11:50 a.m. CEST
Location: Hall B3 – Room 23
Presenter: Mrinal Gounder, M.D.
Proffered Paper (Oral Presentation) Session
Title: Molecular characterization of epithelioid sarcoma (ES) tumors derived from patients enrolled in a phase 2 study of tazemetostat
Abstract No.: 1892O
Date: Saturday, October 20, 2018; 11:12 a.m. – 11:24 a.m. CEST
Location: Hall B3 – Room 21
Presenter: Mrinal Gounder, M.D.
Poster Discussion Sessions
Title: A phase 2, multicenter study of the EZH2 inhibitor tazemetostat in adults (INI1-negative tumors cohort)
Abstract No.: 1611PD
Date: Monday, October 22, 2018; 11:50 a.m. CEST
Location: Hall B3 – Room 23
Presenter: Silvia Stacchiotti, M.D.
Title: A phase 2, multicenter study of the EZH2 inhibitor tazemetostat in adults (rhabdoid tumor cohort)
Abstract No.: 1612PD
Date: Monday, October 22, 2018; 11:50 a.m. CEST
Location: Hall B3 – Room 23
Presenter: Robin L. Jones, MRCP, M.D.
Conference Call Information
Epizyme Management will host a conference call on Monday, October 22, 2018 at 8:30am EDT. To participate in the conference call, please dial 877-844-6886 (domestic) or 970-315-0315 (international) and refer to conference ID 8780088. The webcast can be accessed in the Investor Relations section of the company’s website at www.epizyme.com. The replay of the webcast will be available in the investor section of the company’s website for 60 days.
About the Tazemetostat Clinical Trial Program
Tazemetostat, a potent, selective, orally available, first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma (FL); and combination studies in diffuse large B-cell lymphoma (DLBCL) and non–small cell lung cancer (NSCLC).