Epizyme said today that its lead candidate tazemetostat will be studied with Tecentriq® (atezolizumab) in a Phase Ib/II trial assessing a combination cancer therapy, through the expansion of a two-year-old clinical collaboration with Genentech, a member of the Roche Group.

The expanded collaboration—whose value was not disclosed—will evaluate the combination in patients with relapsed/refractory metastatic non-small-cell lung cancer (NSCLC), according to the companies.

Genentech will sponsor the trial, which is expected to be launched by year’s end. The study is expected to enroll up to 40 patients who have experienced disease progression during or following treatment with a platinum-containing chemotherapy regimen and a programmed death-ligand 1/programmed cell death protein 1 (PD-L1/PD-1) checkpoint inhibitor.

The trial is part of MORPHEUS, Genentech's open-label, multicenter, randomized umbrella study designed to assess the efficacy and safety of multiple immunotherapy-based treatment combinations for metastatic NSCLC.

“The goal of this collaboration is to assess the role this combination therapy may play in immune-cell priming, activation and T-cell infiltration, potentially enhancing an anticancer response,” Scott Clarke, global head, Roche oncology partnering, said in a statement.

The Phase Ib/II study marks Epizyme’s second immuno-oncology combination with Genentech. In June 2016, the companies agreed to evaluate tazemetostat and atezolizumab as a combination regimen in a Phase Ib clinical trial for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.

That combination study is ongoing and continuing to enroll patients, Epizyme said.

Epizyme will retain global development and commercialization rights to tazemetostat. The first-in-class EZH2 inhibitor is currently being studied in ongoing Phase II 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; mesothelioma; as well as in combination studies in DLBCL.

Tazemetostat has been granted Fast Track designation by the FDA 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.

“A key part of Epizyme's long-term vision is expanding the benefit that tazemetostat can bring to a broad range of patients, which includes evaluating tazemetostat in combination with a variety of anticancer agents, such as checkpoint inhibitors,” Epizyme president and CEO Robert Bazemore stated.

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