On August 1, 2017 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, and US Oncology Research, one of the nation’s largest networks of independent, community-based oncology practices dedicated to advancing high-quality treatments through clinical trials, reported a collaboration to screen and identify relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) patients with EZH2 mutations (Press release, Epizyme, AUG 1, 2017, View Source [SID1234519958]). Once identified, eligible candidates will be directed to Epizyme’s ongoing Phase 2 clinical trial of tazemetostat, the Company’s first-in-class EZH2 inhibitor, as a single-agent treatment for relapsed or refractory patients with FL or DLBCL. Schedule your 30 min Free 1stOncology Demo! "Relapsed follicular lymphoma and DLBCL are difficult diseases for which there is generally poor prognosis and limited treatment options for patients," said Michael Seiden, M.D., Ph.D. chief medical officer, US Oncology Research. "Physicians affiliated with US Oncology Research strive to provide access to the treatment strategies that are best suited to each patient. Given the encouraging clinical activity and favorable safety profile demonstrated by tazemetostat in these patient populations, US Oncology Research is pleased to work with Epizyme to offer this screening process so that appropriate patients being treated by an affiliated physician can be promptly directed to a clinical trial evaluating an investigational therapy that is targeted to their cancer."
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Under the collaboration, US Oncology Research will implement a separate screening protocol in 68 locations in the U.S. to identify relapsed or refractory FL and DLBCL patients with tumors bearing EZH2 mutations who may be candidates for enrollment in Epizyme’s ongoing Phase 2 clinical trial. US Oncology Research will direct identified patients to the tazemetostat Phase 2 clinical trial for protocol screening and potential enrollment into the trial. Sites began screening patients in July 2017.
"We are pleased that US Oncology Research, a program recognized for tremendous success in oncology clinical trials and for providing patients with access to novel treatments, is joining our effort to develop a targeted treatment for lymphoma patients with EZH2 mutations," said Peter Ho , chief medical officer of Epizyme. "This collaboration significantly expands our clinical trial footprint within the United States and is expected to further enhance our enrollment of patients whose tumors harbor an EZH2 mutation for our ongoing Phase 2 study of tazemetostat. We believe that tazemetostat has the potential to play a very important role in the targeted treatment of these patients in the future."
About Follicular Lymphoma (FL) and Diffuse Large B-Cell Lymphoma (DLBCL)
FL, an indolent form of non-Hodgkin lymphoma (NHL), is considered to be incurable with existing treatments and is characterized by cycles of relapse that become increasingly difficult to treat with each disease progression. Approximately 25,000 patients in the U.S. and major European countries are diagnosed with FL every year1, of which 15 to 20 percent are estimated to have an EZH2 mutation. There are no approved treatments indicated for patients with FL with an EZH2 mutation. In April 2017, the FDA granted Fast Track designation to tazemetostat for FL regardless of EZH2 mutational status.
DLBCL is an aggressive form of NHL that, once diagnosed, typically requires immediate treatment. Approximately 45,000 patients are diagnosed with DLBCL in the U.S. and major European countries every year2. Among patients with germinal center DLBCL, an estimated 15 to 20 percent have an EZH2 mutation. Forty to 50 percent of patients will relapse on their first-line treatment, which is most commonly the chemotherapy regimen R-CHOP, and there are few treatment options for patients who relapse or become refractory to chemotherapy. In November 2016, the FDA granted Fast Track designation to tazemetostat for DLBCL with EZH2 mutations.
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for FL regardless of EZH2 mutation and for DLBCL with EZH2-activating mutations, as well as Orphan Drug designation for soft tissue sarcoma and malignant rhabdoid tumors.