Epizyme, Inc. reported encouraging preliminary data from its ongoing, global phase II trial on lead pipeline candidate, tazemetostat, at the American Society of Hematology Meeting on Lymphoma Biology.
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being evaluated for the treatment of patients with relapsed or refractory non-Hodgkin lymphoma (NHL).
Early data from the phase II trial showed that tazemetostat had a favorable safety profile and clinical activity consisting of objective responses in a heavily pre-treated patient population. The primary endpoint of the phase II study is the overall response rate.
An Independent Data Monitoring Committee confirmed that futility was surpassed in four of the five cohorts that were being studied – diffuse large B-cell lymphoma (DLBCL) with germinal center B-cell (GCB) subtype and EZH2 mutations; DLBCL with GCB subtype and wild-type EZH2; DLBCL with non-GCB subtype; and follicular lymphoma (FL) with EZH2 mutations.
Enrollment is ongoing in the fifth cohort of patients with FL with wild-type EZH2. The cohort has not reached futility assessment yet.
Meanwhile, enrollment is on track in the phase II study and is consistent with the incidence rates of all NHL subtypes, with approximately 20% of enrolled DLBCL GCB and FL patients having EZH2 mutations. Epizyme continues to enroll patients in its ongoing phase II study on NHL patients as well as in two clinical trials on patients with certain genetically defined solid tumors.
With no approved products in its kitty as of yet, the company’s efforts to develop its lead candidate for a number of indications are impressive. Epizyme expects 2016 to be a critical year given several data readouts lined up from its trials on tazemetostat in NHL and solid tumors.
The company has also outlined a five-year growth strategy and aims to launch tazemetostat globally for both NHL and genetically-defined solid tumors by 2020. It also anticipates moving at least three new oncology programs into clinical development by 2020.
Epizyme currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Pfizer, Inc. (PFE - Free Report) , Bristol-Myers Squibb Company (BMY - Free Report) and Abbott Laboratories (ABT - Free Report) . While Pfizer and Bristol-Myers sport a Zacks Rank #1 (Strong Buy), Abbott Labs is a Zacks Rank #2 (Buy) stock.
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Epizyme, Inc. reported encouraging preliminary data from its ongoing, global phase II trial on lead pipeline candidate, tazemetostat, at the American Society of Hematology Meeting on Lymphoma Biology.
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being evaluated for the treatment of patients with relapsed or refractory non-Hodgkin lymphoma (NHL).
Early data from the phase II trial showed that tazemetostat had a favorable safety profile and clinical activity consisting of objective responses in a heavily pre-treated patient population. The primary endpoint of the phase II study is the overall response rate.
An Independent Data Monitoring Committee confirmed that futility was surpassed in four of the five cohorts that were being studied – diffuse large B-cell lymphoma (DLBCL) with germinal center B-cell (GCB) subtype and EZH2 mutations; DLBCL with GCB subtype and wild-type EZH2; DLBCL with non-GCB subtype; and follicular lymphoma (FL) with EZH2 mutations.
Enrollment is ongoing in the fifth cohort of patients with FL with wild-type EZH2. The cohort has not reached futility assessment yet.
Meanwhile, enrollment is on track in the phase II study and is consistent with the incidence rates of all NHL subtypes, with approximately 20% of enrolled DLBCL GCB and FL patients having EZH2 mutations. Epizyme continues to enroll patients in its ongoing phase II study on NHL patients as well as in two clinical trials on patients with certain genetically defined solid tumors.
With no approved products in its kitty as of yet, the company’s efforts to develop its lead candidate for a number of indications are impressive. Epizyme expects 2016 to be a critical year given several data readouts lined up from its trials on tazemetostat in NHL and solid tumors.
The company has also outlined a five-year growth strategy and aims to launch tazemetostat globally for both NHL and genetically-defined solid tumors by 2020. It also anticipates moving at least three new oncology programs into clinical development by 2020.
Epizyme currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Pfizer, Inc. (PFE - Free Report) , Bristol-Myers Squibb Company (BMY - Free Report) and Abbott Laboratories (ABT - Free Report) . While Pfizer and Bristol-Myers sport a Zacks Rank #1 (Strong Buy), Abbott Labs is a Zacks Rank #2 (Buy) stock.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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