Epizyme, Inc. EPZM announced that the first patient has been dosed in the phase II study on its pipeline candidate, tazemetostat.
The phase II multicenter study will enroll up to 90 patients in three cohorts. The first cohort will comprise patients suffering from malignant rhabdoid tumor, rhabdoid tumor of the kidney, and atypical teratoid rhabdoid tumor. All these tumors are characterized by INI1- or SMARCA4-negativity. While the second cohort comprises patients with non-rhabdoid INI1-negative tumors including epithelial sarcoma, epithelioid malignant peripheral nerve sheath tumor, extraskeletal myxoid chondrosarcoma, myoepithelial carcinoma and renal medullary carcinoma, the third cohort will consist of patients with synovial sarcoma whose INI1 is dysregulated by a reciprocal translocation between chromosome 18 and the X chromosome.
Patients enrolled will be dosed at 800 mg twice daily with tablets taken orally. The primary endpoint is the overall response rate in patients with INI1-negative tumors and progression-free survival (PFS) in patients with synovial sarcoma.
Additionally, Epizyme is enrolling patients in a phase I study in pediatric patients with the same tumor types. This study will enroll approximately 40 patients in a dose-escalation design, which will be followed by a dose-expansion study with an oral suspension of tazemetostat. The primary endpoint of the study is to determine the safety and the ideal dose for the phase II study.
Interim data from the phase II study on tazemetostat in adult patients with genetically defined solid tumors is expected to be presented in late 2016.
We remind investors that in Aug 2015, the company’s Investigational New Drug (IND) application for tazemetostat for studying adult and pediatric patients with INI1-negative solid tumors or synovial sarcoma was accepted by the FDA’s Division of Oncology Products.
Earlier this week, Epizyme’s IND application for tazemetostat was accepted by the FDA’s Division of Hematology Products for the treatment of adults with diffuse large B-cell lymphoma, the most common type of non-Hodgkin lymphoma.
Epizyme currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Baxalta, Inc. BXLT, Horizon Pharmaceuticals HZNP and AstraZeneca PLC AZN. All three sport a Zacks Rank #1 (Strong Buy).
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