Oncolytics Biotech® Announces Update for Potential First-Line Pancreatic Cancer Registration Study

Core Insights - Oncolytics Biotech Inc. is advancing its clinical trial for pelareorep in first-line pancreatic ductal adenocarcinoma (PDAC) and is scheduled to meet with the FDA in mid-November 2025 to discuss study details [1][4] Proposed Registration Study Design - The study design is based on a post-hoc pooled clinical analysis showing a 22% two-year survival rate for patients receiving pelareorep with chemotherapy, compared to 9% for those on chemotherapy alone [3] - The trial will utilize a three-arm design: 1. Gemcitabine + nab-paclitaxel (GnP) control arm 2. GnP + pelareorep 3. GnP + pelareorep + checkpoint inhibitor (CPI) - The primary endpoint is Overall Survival (OS), with statistical rigor to detect significance between investigational arms and the control arm [8] Company Overview - Oncolytics is a clinical-stage biotechnology company focused on developing pelareorep, an investigational immunotherapeutic agent designed to activate immune responses against cancer [5] - The company is also pursuing strategic partnerships to enhance development and commercial impact, with Fast Track designation from the FDA for its programs in metastatic pancreatic and breast cancers [6]