On June 26, 2017 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported that it has expanded its clinical collaboration with Genentech, a member of the Roche Group (Press release, Epizyme, JUN 26, 2017, View Source [SID1234519684]). Under the new agreement, tazemetostat administered in combination with atezolizumab (TECENTRIQ) will be evaluated in a Phase 1b/2 clinical study for the treatment of patients with relapsed/refractory metastatic non-small cell lung cancer (NSCLC). The study will be part of MORPHEUS, Genentech’s open-label, multi-center, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations for metastatic NSCLC. Schedule your 30 min Free 1stOncology Demo! "The MORPHEUS clinical platform is aimed at rapidly evaluating new cancer immunotherapy combination treatment regimens in patients with metastatic NSCLC," said Scott Clarke, global head, Roche oncology partnering. "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 anti-cancer response."
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"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," said Robert Bazemore, president and chief executive officer of Epizyme. "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."
Genentech will sponsor the planned Phase 1b/2 clinical trial, which is expected to be initiated by the end of 2017. It is anticipated that the study will enroll up to 40 patients who have experienced disease progression during or following treatment with a platinum-containing chemotherapy regimen and a PD‑L1/PD-1 checkpoint inhibitor. Financial terms are not disclosed and Epizyme will retain global development and commercialization rights to tazemetostat.
Epizyme’s original collaboration with Genentech was announced in June 2016 to evaluate tazemetostat and atezolizumab as a combination regimen in a Phase 1b 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.
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.