On September 21, 2016 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapeutics, reported that the Company has entered into a collaboration agreement with Foundation Medicine, Inc. to support patient identification and enrollment for Epizyme’s ongoing Phase 2 clinical trial of tazemetostat in patients with non-Hodgkin lymphoma (NHL) (Press release, Epizyme, SEP 21, 2016, View Source [SID:SID1234515264]). Foundation Medicine’s SmartTrials Precision Enrollment Program and FoundationOne Heme panel will assist in identifying a population of individuals with NHL who harbor EZH2 mutations and constitute specific cohorts in the Epizyme trial.
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Tazemetostat is Epizyme’s oral, first-in-class EZH2 inhibitor being investigated in multiple ongoing clinical trials. Early clinical data suggest tazemetostat has encouraging clinical activity and a favorable safety profile in patients with relapsed and refractory NHL.
"This agreement exemplifies our commitment to execute enrollment in our ongoing Phase 2 NHL study, particularly patients with EZH2 mutations," said Robert Bazemore, president and chief executive officer of Epizyme. "We are pleased to partner with Foundation Medicine, an industry leader and innovator in molecular information and comprehensive genomic profiling, to advance our tazemetostat clinical program and accelerate identification of patients who may benefit from this therapy."
FoundationOne Heme is Foundation Medicine’s validated, comprehensive genomic profiling assay, specifically designed for hematological malignancies and sarcomas, which identifies the unique genomic alterations in an individual’s cancer and matches the findings with relevant targeted therapy and clinical trial treatment options for patients. Through this collaboration, Foundation Medicine’s SmartTrials Precision Enrollment program will identify individuals across the U.S. living with NHL who harbor EZH2 mutations as detected by FoundationOne Heme in the course of routine clinical care. The treating physicians of these identified patients will be contacted and informed of Epizyme’s ongoing Phase 2 study of tazemetostat, including relevant details about the trial, to assist the physician in evaluating tazemetostat as a potential treatment option.
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in patients with NHL. It is also being studied in adult and pediatric patients with certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma, and in patients with mesothelioma.
The company plans to initiate additional clinical trials of tazemetostat in 2016, including a combination with R-CHOP in collaboration with the Lymphoma Study Association and a combination with Tecentriq (atezolizumab) in collaboration with Genentech, a member of the Roche Group.
About SmartTrials Precision Enrollment Program and FoundationOne Heme
Foundation Medicine’s SmartTrials Precision Enrollment program leverages the company’s unique combination of broad collaborations with biopharma, industry-leading clinical assays and the FoundationCORE genomic knowledgebase with more than 90,000 real-world genomic profiles to overcome the major roadblocks to today’s clinical trial system, namely patient identification and access to trials.
FoundationOne Heme, an integrated DNA/RNA platform using targeted hybrid-capture next-generation sequencing, is a comprehensive genomic profile developed to detect genomic alterations with therapeutic relevance, including single-nucleotide substitutions, insertions and deletions, copy number alterations and rearrangements, which are not fully evaluated using conventional diagnostic assays. FoundationOne Heme simultaneously detects all classes of genomic alterations in the DNA of 405 cancer-related genes and employs RNA sequencing across 265 genes to capture a broad range of gene fusions, a type of alteration that is a common driver of hematologic cancers. It is designed to provide physicians with clinically actionable information to guide treatment options for patients based on the genomic profile of their cancer.