Epizyme, Inc., announced that the U.S. Food and Drug Administration’s (FDA) Division of Hematology Products has approved its investigational new drug (IND) application for tazemetostat. The drug was developed to treat adults with diffuse large B-cell lymphoma (DLBCL), the most frequent type of non-Hodgkin lymphoma (NHL).
Epizyme, a clinical stage biopharmaceutical company that develops innovative epigenetic therapies for patients with cancer, initiated a registration-supporting Phase 2 clinical trial to assess the safety and activity of tezemetostat in patients with relapsed or refractory (r/r) B-cell NHL in July 2015. IND acceptance now allows the company to enroll DLBCL patients in the U.S. in this trial.
“Tazemetostat has demonstrated clinically meaningful anti-tumor activity and an acceptable safety profile in patients with NHL in our phase 1 study,” Robert Bazemore, Epizyme’s president and CEO, said in a press release. “We are excited to enable U.S. investigators to gain experience with tazemetostat in DLBCL.”
The Phase 2 trial is a five-arm, multicenter and global study using a two-stage design to assess the safety and activity of tazemetostat in several populations of patients with r/r NHL. “Patients with relapsed or refractory NHL have a significant need for new treatment options,” said Peter Ho, MD, PhD, and CMO of Epizyme. “We believe tazemetostat has the potential to become an important therapy for B-cell NHL patients, both as a monotherapy and in combination, and look forward to extending the ongoing five-arm NHL study to allow access to DLBCL patients in the U.S.”
The study will enroll a maximum of 30 patients in each arm, prospectively divided by EZH2 mutation status and cell-of-origin. The five investigational sections are enrolling patients with:
- Germinal center DLBCL with mutant EZH2
- Germinal center DLBCL with wild-type EZH2
- Non-germinal center DLBCL
- Follicular lymphoma with mutant EZH2
- Follicular lymphoma with wild-type EZH2
Epizyme intends to present preliminary data from the trial’s second phase in mid-2016 at a specialized medicine conference, and plans to initiate further clinical assessments of tazemetostat — including a combination study with R-CHOP in front-line, high-risk DLBCL patients, and a combination study with a B-cell signaling agent or immuno-oncology agent in B-cell NHL — in early 2016.
Tazemetostat is being developed by Epizyme to treat NHL patients, and patients with INI1-negative solid tumors, certain SMARCA4-negative solid tumors, or synovial sarcoma. Tazemetostat is a first-in-class small molecule inhibitor of EZH2, an enzyme whose aberrant activity in some cancers results in a misregulation of the genes that stabilize cell proliferation, resulting in the rapid growth of tumor cells.
More information on the trial, including enrollment information, is available through this link (NCT01897571).
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