Epizyme Provides Positive Interim Data On EZH2 Inhibitor

Epizyme, Inc. (NASDAQ:EPZM) announced positive interim data from an ongoing phase II study evaluating pipeline candidate tazemetostat, an oral EZH2 inhibitor, as a monotherapy in patients with relapsed or refractory follicular lymphoma (r/rFL) or diffuse large B-cell lymphoma (DLBCL) based on their EZH2 mutational status. The data were presented at the International Conference on Malignant Lymphoma (ICML).

We remind investors that in the past one year, the candidate has been granted fast track designation for the treatment of patients with DLBCL with EZH2 activating mutations as well as for relapsed or refractory r/rFL, either with type EZH2 or EZH2 activating mutations. The candidate also enjoys orphan drug designation for malignant rhabdoid tumors.

So far this year, Epizyme’s shares are up 2.1%. This compares unfavorably with the 3.1% increase registered by the Zacks classified Biomed/Genetics industry during this period.

The interim data demonstrated that treatment with tazemetostat had clinically meaningful benefit in FL patients as well as promising activity was observed in DLBCL patients. The FL study showed a 92% objective response rate (ORR) for patients with EZH2 activating mutations while almost a quarter of patients with EZH2 wild-type achieved ORR. The study in patients with DLBCL with EZH2 mutations showed 29% ORR and is enrolling more patients.

The company’s lead candidate, tazemetostat is also being evaluated both as monotherapy and in combination with other anti-cancer agents for various form of non-Hodgkin lymphoma, including Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) Tecentriq in DLBCL. The company has an agreement with Eisai Co. Ltd. (OTC:ESALY) for the development and commercialization of tazemetostat and any other EZH2 product candidates in Japan.

We note that there are a few treatments available including Roche’s Rituxan and Gilead Sciences, Inc.’s (NASDAQ:GILD) Zydelig and several companies are developing their candidates for treating cancer targeting EZH2.

However, we are concerned that the company’s pipeline candidates are in early or mid-stage studies and commercialization of any product is still years away subject to positive results and subsequent approval by the FDA. Any pipeline setback will have an adverse impact on the company’s stock.

Zacks Rank

Epizyme carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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