- Oncolytics Biotech (ONCY, Financial) announces promising pelareorep survival data in multiple tumor types.
- Significant survival benefits were observed: 21.9% two-year survival in pancreatic cancer and over 10 months median survival in breast cancer.
- Fast Track designations for pelareorep in metastatic breast and pancreatic cancers enhance regulatory pathway.
Oncolytics Biotech Inc. (ONCY) has unveiled transformative clinical data for its immunotherapy drug, pelareorep, across various cancer types. In a significant development, the company reported a two-year survival benefit of 21.9% for pancreatic cancer (mPDAC) patients compared to a historical benchmark of 9.2%. The objective response rate in mPDAC trials reached an impressive 62% when pelareorep was combined with chemotherapy and checkpoint inhibitors.
In HR+/HER2- metastatic breast cancer trials, pelareorep demonstrated a median overall survival benefit exceeding 10 months compared to standard chemotherapy. Specifically, one study showed a median overall survival of 21.0 months versus 10.8 months in the control group.
The safety profile of pelareorep has been validated in over 1,100 patients, showing primarily manageable flu-like symptoms as side effects. These findings are particularly encouraging for an oncology therapeutic, especially one administered intravenously, as they facilitate combination strategies with existing standard therapies.
Pelareorep has received Fast Track designations from the FDA for metastatic breast cancer since 2017 and for pancreatic cancer since 2022. Additionally, it holds Orphan Drug Designations for pancreatic cancer from both the FDA and the European Medicines Agency (EMA), further accelerating its potential regulatory approval process.
The company plans to leverage these designations by advancing pelareorep into registration-enabling studies, moving away from proof-of-concept trials. Oncolytics Biotech continues to focus on developing pelareorep as a viable immunotherapy option, targeting difficult-to-treat cancers and enhancing its commercial potential.
