Oncolytics Biotech® Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer
Company to launch only current registration trial with an immunotherapy in first-line pancreatic cancer in first half of 2026
Trial design allows flexibility to include an experimental arm with checkpoint inhibitor combination
Excerpt from the Press Release:
SAN DIEGO–(BUSINESS WIRE)–Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced alignment with the U.S. Food and Drug Administration (“FDA”) regarding the design of its pivotal study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC).
The Company and the FDA completed a recent Type C meeting and have agreed on the key elements of the Phase 3 trial, which will evaluate pelareorep in combination with chemotherapy with or without a checkpoint inhibitor (“CPI”) compared to chemotherapy alone. As a result, Oncolytics now has a clear path to launch what it believes will be the only such pivotal study of an immunotherapy in mPDAC, an indication for which immunotherapies have provided very little benefit.
“We now have regulatory clarity to allow us to start a pivotal study and ultimately the chance to bring the first approved immunotherapy treatment option to the pancreatic cancer treatment landscape,” said Jared Kelly, Chief Executive Officer of Oncolytics Biotech.
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