Epizyme, Inc., a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, announced the US Food and Drug Administration's (FDA) Division of Hematology Products has accepted the company's investigational new drug (IND) application for tazemetostat for the treatment of adults with diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL). An ongoing five-arm registration-supporting, international phase 2 clinical trial assessing the safety and activity of tazemetostat in patients with relapsed or refractory B-cell NHL was initiated in July 2015. The IND acceptance will allow the company to enroll DLBCL patients in the United States into this ongoing trial.
"Tazemetostat has demonstrated clinically meaningful anti-tumour activity and an acceptable safety profile in patients with NHL in our phase 1 study," said Robert Bazemore, president and chief executive officer. "We are excited to enable US investigators to gain experience with tazemetostat in DLBCL."
"Patients with relapsed or refractory NHL have a significant need for new treatment options," said Dr. Peter Ho, M.D., Ph.D., chief medical officer, 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 US."
The phase 2 NHL trial is a five-arm, multi-center, international study that will use a two-stage design to assess the safety and activity of tazemetostat in multiple populations of patients with relapsed or refractory non-Hodgkin lymphoma. The study will enroll up to 30 patients in each arm. Patients will be prospectively stratified for EZH2 mutation status and cell-of-origin. The five study arms are enrolling relapsed/refractory 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 expects to present interim data from the phase 2 study in NHL at a medical conference in mid-2016.
In the first half of 2016, the company also plans to initiate additional clinical evaluations of tazemetostat, including a combination study with R-CHOP in front-line, high-risk patients with DLBCL, and a combination study with a B-cell signaling agent or immuno-oncology agent in B-cell NHL.
In August 2015, the FDA's Division of Oncology Products 2 accepted Epizyme's IND application to study adult and paediatric patients with INI1-negative solid tumors or synovial sarcoma.
Epizyme is developing tazemetostat for the treatment of patients with non-Hodgkin lymphoma and for patients with INI1-negative solid tumours, certain SMARCA4-negative solid tumours or synovial sarcoma. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In some human cancers, aberrant EZH2 enzyme activity results in misregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumour cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.