Epizyme, Inc. 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.
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 - Free Report) 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 and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . 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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Epizyme, Inc. 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.
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 - Free Report) 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 and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . 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.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>
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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