FDA Fast Tracks Pelareorep Combination for Patients with Subtype of a Pancreatic Cancer

The combination of pelareorep, Tecentriq, gemcitabine and Abraxane was granted FDA fast-track designation after demonstrating a 69% objective response rate in patients with advanced/metastatic pancreatic ductal adenocarcinoma.

Pelareorep in combination with anti-PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), and the chemotherapeutic agents gemcitabine and Abraxane (nab-paclitaxel) has received fast track designation from the Food and Drug Administration (FDA) for the treatment of patients with advanced/metastatic pancreatic ductal adenocarcinoma, according to a press release from Oncolytic Biotech Inc., the investigative drug’s manufacturer.

A fast-track designation is granted by the FDA to a drug that has potential to treat a serious condition or fulfill an unmet need. In doing so, its purpose is to expedite the development and review process.

The designation is based on results from the phase 1/2 GOBLET study presented at the Society for Immunotherapy of Cancer 37th Annual Meeting which demonstrated a 69% objective response rate (the rate of a measurable response to the treatment) with the combination. Additionally, 13 patients demonstrated complete response (the disappearance of cancer as a response to treatment).

Of note, this is almost triple the average objective response rate typically seen when evaluating gemcitabine and Abraxane in patients with pancreatic cancer.

“Receiving this fast-track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our (pancreatic ductal adenocarcinoma) study,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., in the release. “It also reflects the pressing need to improve upon the standard of care in this indication."

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