Epizyme and LYSA Open Clinical Trial of Combo Therapy for Diffuse Large B-Cell Lymphoma

Epizyme and LYSA Open Clinical Trial of Combo Therapy for Diffuse Large B-Cell Lymphoma

Epizyme, Inc., and the Lymphoma Study Association (LYSA) will jointly investigate the combination of tazemetostat and R-CHOP as a frontline treatment in patients with diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma (NHL).

Most NHLs originate in B-cells, a type of immune cell responsible for fighting infections through the production of antibodies. Lymphomas starting in either B-cells or T-cells significantly influence both prognosis and treatment.

The open-label trial will be conducted at multiple sites in France and will enroll elderly, high-risk patients with recently diagnosed DLBCL. In the Tazemetostat clinical trial program, patients will receive tazemetostat, an oral first-in-class EZH2 inhibitor, in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) — a standard treatment in newly diagnosed DLBCL.

Epizyme also reported plans to initiate additional clinical evaluations of tazemetostat in 2016, including a combination study with an immune-checkpoint inhibitor in NHL patients, and a monotherapy study in adult mesothelioma patients.

“We are pleased to have established a collaboration with LYSA and to conduct the first investigation of tazemetostat in the front-line treatment setting,” Robert Bazemore, Epizyme’s president and chief executive officer, said in a press release. “This study agreement aligns with Epizyme’s strategy of partnering with world-class research organizations to accelerate our development programs. The planned combination trial builds on preclinical evidence of synergy between tazemetostat and R-CHOP, and will add to what we know about the utility of tazemetostat in patients with non-Hodgkin lymphoma.”

Epizyme and LYSA will lead the Phase 1b/2 clinical trial together with LYSA’s operational arm, the Lymphoma Academic Research Organization (LYSARC), which is sponsoring the study.

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A new investigational compound targeting a specific protein that is frequently mutated and malfunctioning in lymphoma and melanoma patients has shown promising results in mice cancer models. The study, “An oncogenic Ezh2 mutation induces tumors through global redistribution of histone 3 lysine 27 trimethylation,” was recently published in the journal Nature Medicine.

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