Oncolytics Biotech (NASDAQ: ONCY) announced updates for its planned registration-directed clinical trial in first-line pancreatic ductal adenocarcinoma (PDAC). The company will meet with the FDA in mid-November 2025 to discuss study details.
The proposed trial features a three-arm design evaluating: 1) Gemcitabine + nab-paclitaxel (GnP) control, 2) GnP + pelareorep, and 3) GnP + pelareorep + checkpoint inhibitor. The study's primary endpoint is Overall Survival, with planned interim analysis for early efficacy assessment.
Previous post-hoc analysis showed pelareorep plus chemotherapy achieved 22% two-year survival rate compared to 9% with chemotherapy alone. The company aims to establish pelareorep as the first approved immunotherapy in first-line pancreatic cancer.
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