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Arcus Biosciences’ Quemliclustat Receives Orphan Drug Designation for Pancreatic Cancer
HAYWARD, Calif., July 10, 2025--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, today announced that quemliclustat, an investigational small molecule CD73 inhibitor, was granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer.
About this update from Arcus Biosciences, Inc.
[{"type":"text","content":"PRISM-1, the ongoing registrational, Phase 3 study evaluating quemliclustat plus chemotherapy as a first-line treatment for metastatic pancreatic cancer, is expected to be fully enrolled by the end of this year.","length":211,"tagName":"p","attribs":{}},{"type":"text","content":"HAYWARD, Calif., July 10, 2025--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, today announced that quemliclustat, an investigational small molecule CD73 inhibitor, was granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer.","length":438,"tagName":"p"},{"type":"text","content":""The orphan drug designation indicates the importance of developing new treatment options for rare diseases like pancreatic cancer, which has the highest mortality rate of all major cancers, and which has seen few treatment advancements over the past 30 years," said Richard Markus, M.D., Ph.D., chief medical officer at Arcus Biosciences. "We expect the Phase 3 PRISM-1 study to be fully enrolled this year and, if positive, intend to quickly bring this new first-line treatment option to patients, with the goal of prolonging survival for those with metastatic pancreatic cancer."","length":602,"tagName":"p"},{"type":"text","content":"Orphan drug designation is intended to support the development and evaluation of new treatments for rare diseases affecting fewer than 200,000 people in the United States. Orphan drug designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees including New Drug Application (NDA), and a potential seven years of market exclusivity after approval.","length":411,"tagName":"p"},{"type":"text","content":"In January 2024, Arcus presented results from the Phase 1 ARC-8 study, which showed no new safety signals and median overall survival (OS) of 15.7 months in a pooled analysis of all patients treated with the 100mg quemliclustat-based regimens. The median OS exceeded the historical benchmark data for chemotherapy alone, including for patients with liver metastasis, which account for more than half of all pancreatic cancers. Based on the ARC-8 results, the company init...