Epizyme, Inc. EPZM announced positive interim data from an ongoing phase II study of its lead candidate, tazemetostat, as a monotherapy for patients with relapsed or refractory follicular lymphoma (“FL”) who have received at least two prior lines of systemic therapy.
The primary endpoint of the study is objective response rate (“ORR”). Secondary endpoints include duration of response, overall survival, and progression free survival and safety.
Shares of the company have increased 143% year to date compared with the industry’s 6.8% growth.
Follicular lymphoma patients, who had been previously treated with two or more systemic therapies, were enrolled in a trial composed of two cohorts in the phase II study. One cohort enrolled patients with EZH2 activating mutations and the second cohort comprised patients with wild-type EZH2. In the cohort of patients with EZH2 activating mutations, 40% of patients were refractory to their last treatment; 40% were refractory to a rituximab regimen and 22% were double refractory. The ORR in this cohort was 77%, and 100% of patients experienced a reduction in tumor burden, with no patients having experienced progressive disease as best response.
In the wild-type EZH2 cohort, 37% were refractory to their last treatment; 61% were refractory to a rituximab regimen; and 39% were double refractory. All the patients were treated with 800 mg of tazemetostat, administered orally twice a day. The ORR in this cohort was 34%, and 71% of patients experienced a reduction in tumor volume.
Interim safety results showed that only 5% of FL patients discontinued treatment and 9% had dose reductions due to treatment-related adverse events.
It remains on track to submit a new drug application for tazemetostat in FL in the fourth quarter of 2019.
We remind investors that tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing phase II programs in patients with certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; both FL and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; mesothelioma; and combination studies in DLBCL and Non-small-cell lung carcinoma.
Epizyme, Inc. Price
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Zacks Rank and Stocks to Consider
Epizyme currently has a Zacks Rank #2 (Buy).
Some better-ranked stocks in the biotech sector are Anika Therapeutics Inc. ANIK, Applied Genetics Technologies Corp. AGTC and Acorda Therapeutics Inc. ACOR, each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings per share estimates have moved up from $1.21 to $1.31 for 2019 and from $1.21 to $1.33 for 2020 in the past 60 days. The company beat earnings estimates in the trailing four quarters, with the average being 72.00%.
Applied Genetics’ loss per share estimates have narrowed from $1.25 to 1 cent for 2019 and from $2.39 to $2.15 for 2020 in the past 60 days. The company surpassed earnings estimates in three of the trailing four quarters, with average positive surprise of 83.47%.
Acorda’s loss per share estimates have narrowed from $3.84 to $3.59 for 2019 and from $3.32 to $3.09 for 2020 in the past 60 days. The company outpaced earnings estimates in the trailing four quarters, with the average being 79.32%.
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