Oncolytics Biotech Inc. announced an update on the proposed design of its planned registration-directed clinical trial in first-line pancreatic ductal adenocarcinoma (PDAC). The company is scheduled to meet with the U.S. Food and Drug Administration (FDA) in mid-November 2025 to advance the study details. This meeting is a critical step in finalizing the pathway for pelareorep in this aggressive cancer.
The proposed study design is a well-powered, three-arm trial that will evaluate pelareorep with chemotherapy and in combination with checkpoint inhibition. This design builds on a post-hoc, pooled clinical analysis that demonstrated the addition of pelareorep to chemotherapy achieved an approximate 22% two-year survival rate, significantly higher than the 9% observed for patients treated with chemotherapy alone in historical benchmarks.
Jared Kelly, Chief Executive Officer of Oncolytics, stated that this trial design is expected to deliver meaningful data for patients and regulators, positioning pelareorep as a potential first-approved immunotherapy in first-line pancreatic cancer. This transformative milestone in oncology is also anticipated to be recognized by potential partners, enhancing the program's value.
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