CAMBRIDGE, Mass.—Biopharmaceutical company Epizyme Inc. and Genentech, a member of the Roche Group, have expanded their clinical collaboration exploring combination cancer treatments with tazemetostat. Per the terms of the new agreement, Epizyme's tazemetostat and Genentech's atezolizumab, an anti-PD-L1 immunotherapy, will be evaluated as a combination therapy in a Phase 1b/2 clinical study in patients with relapsed/refractory metastatic non-small cell lung cancer (NSCLC). This study will be part of Genentech's MORPHEUS study, which is aimed at assessing the safety and efficacy of multiple immunotherapy-based treatment combinations for metastatic NSCLC.
Genentech will sponsor the clinical trial, which is slated to begin by the end of the year, enrolling up to 40 patients who have seen disease progression during or following treatment with a platinum-containing chemotherapy regimen and a PD-L1/PD-1 checkpoint inhibitor. No financial terms were released, but Epizyme will retain global development and commercialization rights to tazemetostat.
"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 anti-cancer agents, such as checkpoint inhibitors," Robert Bazemore, president and CEO of Epizyme, said in a press release. "NSCLC is a devastating form of lung cancer affecting nearly 200,000 people in the U.S. and major European countries. This study marks our second immuno-oncology combination with Genentech, and we look forward to working together to understand the benefit combination treatment with tazemetostat and atezolizumab may have for patients with this difficult cancer."
Tazemetostat is a first-in-class EZH2 inhibitor and is being evaluated in ongoing Phase 2 programs in follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; select molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma, as well as in combination studies in DLBCL. The U.S. Food and Drug Administration has granted the drug Fast Track designation for follicular lymphoma regardless of EZH2 mutation and for DLBCL with EZH2-activating mutations. Tazemetostat has also received Orphan Drug designation malignant rhabdoid tumors.
The companies' original collaboration was announced last June, and was established to evaluate a combination regimen of tazemetostat and atezolizumab in a Phase 1b clinical trial in patients with relapsed or refractory DLBCL, with Genentech responsible for managing study operations for the trial. The study is still ongoing.
In addition, in other recent news, Epizyme announced that tazemetostat has also been granted Orphan Drug designation for soft tissue sarcoma, a cancer that occurs in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue. This cancer type can manifest anywhere in the body, regardless of age, and is aggressive and difficult to treat. The American Cancer Society estimates that some 13,000 individuals will be diagnosed with this cancer type this year.
"This is an important milestone for Epizyme, as we advance tazemetostat through clinical development," said Bazemore in a press release announcing the news. "We are encouraged by the positive regulatory milestones we have achieved for tazemetostat, including this Orphan Drug designation for soft tissue sarcomas. We look forward to our continued engagement with the FDA as we work to bring tazemetostat to patients with both solid tumors and hematological malignancies as quickly as possible."
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