Epizyme Inc. EPZM announced results from a phase I trial on pipeline candidate, tazemetostat (EPZ-6438), at the 57th American Society of Hematology Annual Meeting.
EPZ-6438, a first-in-class inhibitor, is being evaluated for the treatment of patients with non-Hodgkin lymphoma (NHL) and INI1-deficient solid tumors. This open-label, multicentre, phase I study is investigating tazemetostat as monotherapy in patients with relapsed or refractory B-cell NHL or advanced solid tumors. The primary objective of the trial includes the identification of the recommended phase II dose or maximum-tolerated dose, safety, tolerability, pharmacokinetics and preliminary evaluation of anti-tumor activity.
Data from the trial showed that tazemetostat demonstrated meaningful clinical activity, as an oral monotherapy, in patients with either relapsed or refractory NHL. It was observed that 9 of 16 response-evaluable patients with NHL achieved an objective response, with the duration of responses lasting up to 19 months.
Meanwhile, Epizyme is conducting an international, multi-center, phase II study comprising five independent arms on tazemetostat. Patient enrollment for the study began in the second half of 2015.
The study will assess the safety and efficacy of 800 mg BID of tazemetostat in patients with relapsed or refractory NHL, stratified by cell of origin and EZH2 mutation status. Interim results from this study are expected by mid-2016. The study is expected to support registration of the candidate.
The successful development and commercialization of tazemetostat will provide a significant boost to the company, which currently has no approved products in its kitty.
Epizyme 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, each sporting a Zacks Rank #1 (Strong Buy).
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