Strata Oncology said today it will support patient identification and enrollment for Epizyme's ongoing Phase II clinical trial of tazemetostat in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL).

The value of the clinical collaboration was not disclosed.

Strata is conducting an observational study designed to provide no-cost tumor sequencing to 100,000 advanced cancer patients, as well as offer pharma companies exclusive access to stratified patient populations, with the goal of shortening clinical development timelines.

Launched in December 2016, the Strata trial “aims to study the impact of sequencing on clinical trial enrollment,” Strata Oncology states on its website, adding: “Our goal is to dramatically expand patient access to tumor sequencing and precision medicine trials, and to accelerate the approval of breakthrough cancer medicines.”

At the time of the trial’s launch, Strata had completed collaboration agreements with its first two cancer center partners, University of North Carolina (UNC) Lineberger Comprehensive Cancer Center and University of Alabama (UAB) Comprehensive Cancer Center.

As part of the trial, Strata Oncology said, it will identify individuals with NHL whose tumors have EZH2-activating mutations for potential enrollment into Epizyme's ongoing Phase II clinical trial of tazemetostat.

“The addition of tazemetostat to Strata's growing portfolio of programs furthers our goal of providing cancer patients with greater access to clinical trials specific to their cancer type,” Strata Oncology President and CEO Dan Rhodes, Ph.D., said in a statement.

Tazemetostat is an orally administered, first-in-class small-molecule EZH2 inhibitor under development to treat multiple types of hematological malignancies and genetically defined solid tumors.

Tazemetostat is under study as a single-agent therapy in multiple clinical trial, including Phase II clinical trials in patients with relapsed or refractory NHL; adult patients with certain genetically defined solid tumors, including INI1-negative tumors and synovial sarcoma; and patients with mesothelioma characterized by BAP loss of function.

Epizyme is also conducting a clinical trial of tazemetostat in pediatric patients with certain genetically defined solid tumors, including INI1-negative tumors and synovial sarcoma, as well as clinical trials where tazemetostat is being evaluated as part of combination therapies. One study is assessing tazemetostat with the chemotherapy regimen R-CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone, plus the monoclonal antibody rituximab) as a first-line treatment for newly diagnosed elderly, high-risk patients with the most common type of NHL, diffuse large B-cell lymphoma (DLBCL)—a study being conducted with the Lymphoma Study Association.

In early clinical development, according to Epizyme, tazemetostat has demonstrated clinical activity and a generally well-tolerated safety profile in both patients with hematological malignancies and genetically defined solid tumors.

Epizyme holds development and commercialization rights to tazemetostat worldwide except Japan, where Eisai holds those rights, as well as a right of first negotiation to rights in the rest of Asia.








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