On September 14, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that clinical data will be presented at the upcoming 2021 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress, taking place on September 16-21, 2021 (Press release, Epizyme, SEP 14, 2021, View Source [SID1234587681]).
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At the conference there will be two posters on two of the trials examining tazemetostat use in solid tumors. One details updated data from the ongoing safety run-in portion of the EZH-1101 prostate cancer study evaluating tazemetostat in combination with either abiraterone/prednisone or enzalutamide. The second poster describes the ongoing study investigating tazemetostat’s use in combination with other agents to treat solid tumors.
"Consistent with the preliminary data we shared during our Next Episode vision call earlier this year, the data presented at ESMO (Free ESMO Whitepaper) from our EZH-1101 study suggest tazemetostat combinations in prostate cancer led to a subset of patients having durable ≥50% decline in prostate-specific antigen levels (PSA50) with one patient having a radiographic tumor response," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "We are encouraged to see the progression free survival data with a follow-up of almost two years in the safety run-in, and this data, while still maturing, will be shown in the poster session. Additionally, the adverse events data with the combination treatment were consistent with the known safety profile of the individual agents with no new safety signals. The randomized portion of the EZH-1101 study is ongoing with more than one-third of patients enrolled to date. This study is one part of our overall program exploring tazemetostat as both monotherapy and in combinations across multiple hematologic and solid tumor cancers."
Details of the presentations are listed below:
ESMO Poster Presentations
Title: Safety of Tazemetostat in Combination With Abiraterone/Prednisone or Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
Presenters: Wassim Abida, MD, PhD; Daniel Saltzstein, MD
Abstract Code: 586P
Title: Trial in Progress: Tazemetostat in Combination With a PARP Inhibitor or Durvalumab in Patients With Solid Tumors
Presenter: Charles M. Rudin, MD, PhD; Robert L. Coleman, MD
Abstract Code: 1870TiP
The ESMO (Free ESMO Whitepaper) abstracts are available at View Source All oral and poster presentations will be available on the ESMO (Free ESMO Whitepaper) website on Thursday, September 16, 2021 8:30 a.m. CEST / 2:30 a.m. ET.
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.
View the U.S. Full Prescribing Information here: Epizyme.com