Type C meeting with FDA supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC) concluded
“Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep’s immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options.”
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