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Oncolytics Biotech® Announces Update for Potential First-Line Pancreatic Cancer Registration Study
SAN DIEGO, Sept. 29, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company
About this update from Oncolytics Biotech Inc.
[{"type":"text","content":"\n SAN DIEGO, Sept. 29, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (\"Oncolytics\" or the \"Company\"), a clinical-stage immunotherapy company developing pelareorep, today announced an update on the proposed design of its planned registration-directed clinical trial in first-line pancreatic ductal adenocarcinoma (PDAC). The Company is currently scheduled to meet with the U.S. Food and Drug Administration (FDA) in mid-November 2025 to advance study details.\n \n \n \n \n \n \n \n \n Key Elements of the Proposed Registration Study\n \n \n Three-arm design - patients will be randomized to receive:1. Gemcitabine + nab-paclitaxel (GnP) control arm.2. GnP + pelareorep.3. GnP + pelareorep + checkpoint inhibitor (CPI).\n Primary endpoint: Overall Survival (OS).\n Statistical rigor: The trial will be powered to detect statistical significance between the investigational arms and the control arm.\n Planned interim analysis: An interim efficacy analysis will be incorporated to enable early assessment of potential clinical benefit.\n \n This proposed design builds on a post-hoc, pooled clinical analysis, which found that the addition of pelareorep to chemotherapy achieved an approximate 22% two-year survival rate, compared to just 9% for patients treated with chemotherapy alone, as in historical, third-party benchmarks (link to the PR).\n \"We are excited to advance this potential registration-directed study in first-line pancreatic cancer with a well-powered, three-arm design,\" said Jared Kelly, Chief Executive Officer of Oncolytics. \"By evaluating pelareorep with chemotherapy and in combination with checkpoint inhibition, we expect to position this program to deliver meaningful data for patients and regulators alike. We believe that potential partners will recognize the possibility this trial design presents to establish pelareorep as the first approved immunotherapy in first-line pancreatic cancer - a transformative milestone in oncology.\"\n \n About Oncolytics Biotech Inc.\n \n Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studie...