Epizyme Announces Removal of FDA’s Partial Ban in Phase II Clinical Trials

Clinical Trial Data

Epizyme, Inc. (NASDAQ: EPZM), an innovative epigenetic therapy development company, announced this morning that the U.S. Food and Drug Administration (FDA) has removed their former partial clinical hold reported in April of this year. The hold formerly suspended new U.S. patient enrollment in trials involving tazemetostat, which the company describes as “an orally administered, first-in-class small molecule EZH2 inhibitor, for the treatment of multiple types of hematological malignancies and genetically defined solid tumors”. Moving forward, Epizyme will be resuming enrollment in ongoing Phase II trials in certain molecularly-defined solid tumors — including epithelioid sarcoma and other INI1-negative tumors — and hematologic malignancies, including follicular lymphoma, diffuse large B-cell lymphoma and non–small cell lung cancer (NSCLC).

“With today’s news, Epizyme will turn its attention to key corporate priorities in epithelioid sarcoma (ES) and follicular lymphoma (FL). The company is now focusing on completing enrollment in the FL EZH2 activating mutation cohort of its Phase 2 NHL trial and advancing toward the company’s first NDA submission in ES. Additionally, Epizyme plans to present updated Phase 2 data of tazemetostat monotherapy in ES at the upcoming ESMO Congress in October 2018,” writes a company spokesperson on behalf of Epizyme.

Interim data collected by May of this year involved 82 patients across two cohorts, revealing an objective response rate (ORR) of 71 percent in the EZH2 activating mutation cohort, with 11 percent of patients achieving complete response (CR), and 61 achieving partial response (PR). Furthermore, the company stated that 29 percent of patients achieved stable disease (SD) as best response, with 21 percent of those having the potential to present more future data. After the partial clinical hold was announced, Epizyme formally responded to the FDA with exhaustive data, proving the company’s commitment to safety and efficacy. The company included a thorough risk assessment of tazemetostat’s risk of secondary malignancies and utilized a diverse panel of outside medical and scientific authorities who confirmed Epizyme’s findings.

Epizyme President and Chief Executive Officer Robert Bazemore states that “the Epizyme team has worked diligently to provide a comprehensive response back to the FDA, and through constructive dialogue, we successfully resolved the partial clinical hold. This allows us to turn our full attention to our key priorities: preparing for our first NDA submission for tazemetostat in epithelioid sarcoma and defining our registration path in FL. We, along with our investigators and the global experts we consulted to support our complete response, continue to believe in the positive benefit/risk of tazemetostat as we move forward in our clinical development program. We remain steadfast in our commitment to bringing this potential therapeutic option to cancer patients in need of safe and effective new treatments.”

Non-Hodgkin's Lymphoma (NHL) is termed to umbrella multiple different types of lymphoma with similar characteristics. With early detection, prognosis can be effectively positive, but current standard treatments for both early and late stage lymphoma can be both painful and difficult. Even the American Cancer Society recommends consideration of clinical trials to cancer patients searching for more effective alternative treatments. As Epizyme’s website states, “At Epizyme, our exceptional team is wholly dedicated to bringing epigenetic therapies to the many patients who can benefit from them. We believe that we have the opportunity to change the lives of patients living with cancer and other serious diseases and are well positioned to deliver on our multi-year vision.” Without the partial ban, Epizyme can continue to affect positive change in cancer treatment possibility.

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