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Epizyme Non-Hodgkin Lymphoma Drug Clears Futility Hurdle

Zacks Equity Research
Updated

Epizyme, Inc. EPZM reported that an Independent Data Monitoring Committee had convened earlier this week to assess the futility of its lead candidate tazemetostat for the treatment of follicular lymphoma.

The committee analyzed the wild-type EZH2 cohort of the company’s ongoing phase II study in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) and determined that the study cohort has surpassed the pre-specified futility hurdle. As a result, the company will continue to accrue patients to fully enroll this cohort.

Data demonstrated that patients enrolled in the cohort achieved complete and partial responses. The safety profile of the candidate was stable and there were no safety concerns raised by the IDMC in their review. With the green signal from IDMC, all five study cohorts have surpassed their pre-specified futility hurdles, and enrollment is ongoing in all of them. Epizyme plans to present mature data from all the five study cohorts in the first half of 2017.

We note that apart from NHL, tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing studies in certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma, and mesothelioma.

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EPIZYME INC Price

 

EPIZYME INC Price | EPIZYME INC Quote

Further, the company plans to initiate additional clinical trials on tazemetostat in 2016, including a combination with R-CHOP in collaboration with the Lymphoma Study Association and in combination with Roche’s RHHBY Tecentriq in patients with diffuse large B-cell lymphoma.

The company targets to launch tazemetostat globally in both the non-Hodgkin lymphoma (NHL) and genetically defined solid tumor indications by 2020. With no approved product in its kitty yet, successful development and commercialization of tazemetostat is critical for Epizyme’s growth.

Epizyme currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector include Actelion Ltd ALIOF and ANI Pharmaceuticals, Inc. ANIP. Both the stocks sport a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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