Date: 2016-05-09
Type of information: Clinical research agreement
Compound: tazemetostat - EPZ-6438 (E7438) with R-CHOP
Company: Epizyme (USA - MA) Lymphoma Study Association (LYSA) (France)
Therapeutic area: Cancer - Oncology
Type agreement: collaboration clinical research
Action mechanism: enzyme inhibitor/histone methyltransferase inhibitor. EZH2 is a histone methyltransferase (HMT) that is increasingly understood to play a potentially oncogenic role in a number of cancers. These include germinal center (GC) non-Hodgkin lymphomas, INI1-deficient cancers such as synovial sarcoma and malignant rhabdoid tumors, and a range of other solid tumors. EPZ-6438 is a small molecule inhibitor of EZH2 created with Epizyme’s proprietary product platform, for the treatment of non-Hodgkin lymphoma patients. In many human cancers, misregulated EZH2 enzyme activity results in misregulation of genes that control cell proliferation — without these control mechanisms, cancer cells are free to grow rapidly. Epizyme granted Eisai a worldwide license to EPZ-6438 (Eisai refers to this therapeutic candidate as E7438), subject to Epizyme's right to opt in for co-development, co-commercialization and profit share arrangement with Eisai in the United States. Epizyme is working with Roche and Eisai to develop a companion diagnostic to identify patients with non-wild type EZH2, where EZH2 contains point mutations.
Disease: diffuse large B-cell lymphoma (DLBCL)
Details: * On May 9, 2016, Epizyme announced that it has entered into a collaboration agreement with the Lymphoma Study Association (LYSA) to investigate the combination of tazemetostat with R-CHOP as a front-line treatment in patients with diffuse large B-cell lymphoma (DLBCL). LYSA is a premier cooperative group in France dedicated to clinical and translational research for lymphoma, and is certified by the French National Cancer Institute . Under the agreement, the phase 1b/2 trial will be jointly conducted with the Lymphoma Academic Research Organisation (LYSARC), the operational arm of LYSA. The planned combination trial builds on preclinical evidence of synergy between tazemetostat and R-CHOP.
This open-label, clinical study will be sponsored by LYSARC and conducted at multiple sites in France . The study will enroll elderly, high-risk patients with newly diagnosed DLBCL, the most common form of non-Hodgkin lymphoma. Patients will receive tazemetostat in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), a standard treatment in newly diagnosed DLBCL. Epizyme and LYSARC jointly designed the study, which is expected to begin enrolling patients mid-year.
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