On May 12,, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that new preclinical and clinical data will be presented at upcoming medical meetings in June (Press release, Epizyme, MAY 12, 2021, View Source [SID1234579825]).
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"We look forward to sharing our preclinical data at EHA (Free EHA Whitepaper) that provide the therapeutic rationale for targeting SETD2 in multiple myeloma and are so pleased that it has been chosen for an oral presentation. These data are the basis for moving our SETD2 inhibitor program forward and, as we have previously reported, we remain on track for our planned IND submission in mid-2021 and plan to initiate a first-in-human clinical trial by year end," said Dr. Jeffery Kutok, Epizyme’s Chief Scientific Officer. "As our SETD2 inhibitor program began to take shape, we were struck by the many parallels we saw with our EZH2 inhibitor, TAZVERIK (tazemetostat). SETD2 is a histone methyltransferase, like EHZ2, and plays multiple key roles in cellular processes and cancer. We’re excited about the potential of SETD2 inhibition in several settings, including high-risk t(4;14) myeloma, and more broadly in myeloma without the t(4;14) mutation, as well as other B-cell malignancies. We see potential as a monotherapy, as well as in combination with existing and emerging therapies in myeloma, with preclinical data also showing synergy with tazemetostat."
"We are excited to share safety and preliminary activity data related to the EZH-301 confirmatory study of tazemetostat in Epithelioid Sarcoma (ES) at ASCO (Free ASCO Whitepaper), a key milestone toward our goal of demonstrating the benefits of tazemetostat to patients in earlier lines of treatment for ES and Follicular Lymphoma by exploring combinations with standard of care therapies," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "As we outlined during our recent Vision Call, we plan to further explore tazemetostat as both monotherapy and in combinations across multiple hematologic and solid tumor cancers in clinical studies, which are on track to initiate later this year."
Details of the presentations are listed below:
EHA Oral Presentation
Title: Discovery of a selective inhibitor of the SETD2 histone methyltransferase with potent in vitro and in vivo activity in preclinical models of multiple myeloma
Session: Basic and translational myeloma research
Presenter: Dr. Jennifer Totman
Abstract Code: S176
Live Q&A: Monday, June 14; 2021 8:45-9:30 p.m. CEST/2:45-3:30 p.m. EDT.
The EHA (Free EHA Whitepaper) abstracts are available at View Source All oral and poster presentations will be available on the EHA (Free EHA Whitepaper) website on Friday, June 11, 2021 at 9:00 a.m. CEST/3:00 a.m. EDT.
ASCO Poster Presentation
Title: Results of the phase 1b soft-tissue sarcoma (STS) portion of the global randomized, double-blind, placebo-controlled study of tazemetostat (TAZ) plus doxorubicin (DOX) as frontline therapy for advanced epithelioid sarcoma (ES)
Session: Sarcoma
Presenter: Sant P. Chawla, M.D.
Abstract No.: 11563
The ASCO (Free ASCO Whitepaper) abstracts are available at View Source All oral and poster presentations will be available on the ASCO (Free ASCO Whitepaper) website on Friday, June 4, 2021 at 9:00 a.m. EDT.
About TAZVERIK (tazemetostat)
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:
Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.