Oncolytics Biotech (US:ONCY) Prnewswire·2025-07-08 12:30Core Insights - Oncolytics Biotech Inc. has reported compelling clinical data for its oncolytic virus immunotherapy, pelareorep, showing a significant two-year survival benefit of 21.9% in metastatic pancreatic ductal adenocarcinoma (mPDAC) compared to a historical benchmark of 9.2% [1][2] - The company is shifting its strategy to focus on advancing pelareorep into registration-enabling trials, leveraging its fast-track status to expedite the regulatory process [2][7] - Pelareorep has demonstrated a favorable safety profile across over 1,100 patients, with common treatment-related adverse events being manageable and transient [6][8] Clinical Data Summary - In mPDAC trials, pelareorep combined with chemotherapy showed a 2-year overall survival rate of 21.9% versus 9.2% from historical data, with a 62% objective response rate (ORR) in a single-arm study [2][3] - In HR+/HER2- metastatic breast cancer, pelareorep has shown a median overall survival benefit of over 10 months compared to standard chemotherapy, with specific studies indicating mOS of 21.0 months versus 10.8 months [5][6] - The disease control rate (DCR) for pelareorep in combination with gemcitabine was reported at 83%, significantly higher than the 33% benchmark [3] Regulatory and Developmental Status - Pelareorep has received Fast Track designations from the FDA for both metastatic breast cancer and mPDAC, indicating its potential as a significant therapeutic option [7][9] - The company is planning combination clinical trials with pelareorep in various solid tumors as it moves towards registrational studies [9]