Oncolytics’ pelareorep selected for Precision Promise Phase 3 platform trial

Oncolytics announced pelareorep has been selected for inclusion as a new investigational treatment in Precision Promise, an adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma. Precision Promise has a primary endpoint of overall survival and can include multiple investigational treatments. This design, which was developed with guidance from the FDA, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared to non-platform trials. Oncolytics expects to open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine, and nab-paclitaxel in early 2024.