On July 24, 2017 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported that the National Cancer Institute (NCI), part of the National Institutes of Health, has initiated its NCI-COG Pediatric MATCH study, which includes a phase 2 evaluation of tazemetostat as one of its treatment arms. Conducted under Epizyme’s Cooperative Research and Development Agreement (CRADA) executed with NCI in 2016, this multi-institutional study will evaluate tazemetostat as a monotherapy for pediatric patients with advanced solid tumors, including CNS tumors, non-Hodgkin lymphoma or histiocytic disorders that harbor gain of function mutations in EZH2, or loss of function mutations in the SWI/SNF complex subunits SMARCB1 or SMARCA4. The Pediatric MATCH study, which will be operationalized by the Children’s Oncology Group (COG), aims to match targeted agents, such as tazemetostat, with specific molecular changes identified through genomic sequencing of refractory/recurrent tumors from children and adolescents with cancer. Schedule your 30 min Free 1stOncology Demo! "We are very pleased to be participating in the Pediatric MATCH trial as it will allow us to extend our exploration of tazemetostat’s potential clinical utility in the treatment of molecularly targeted tumors," said Peter Ho, M.D., Ph.D., chief medical officer of Epizyme. "We look forward to working with the NCI and COG investigators to advance our understanding of tazemetostat’s potential against these devastating cancers in children and adolescents."
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"This trial would not have been possible without the enthusiastic support of the partnering pharmaceutical companies, as evidenced by their willingness to provide targeted agents for this trial," said NCI study co-chair Nita Seibel, M.D., of NCI’s Division of Cancer Treatment and Diagnosis.
As part of the CRADA executed between Epizyme and NCI in 2016, NCI has agreed to collaborate with Epizyme on clinical trials to evaluate the safety and efficacy of tazemetostat in both adult and pediatric patients with hematologic malignancies and solid tumors. As part of the agreement, NCI will fund and sponsor all clinical trials conducted under this collaboration.
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 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 follicular lymphoma 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.
About the NCI-COG Pediatric MATCH Trial1
Pediatric MATCH is a precision medicine cancer treatment clinical trial that analyzes patients’ tumors to determine whether they contain genetic abnormalities for which a targeted drug exists (that is, "actionable mutations") and assigns treatment based on the abnormality. This trial seeks to determine whether treating cancers according to their molecular abnormalities will show evidence of effectiveness.