On June 22, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported pelareorep has been selected for inclusion as a new investigational treatment in Precision PromiseSM, an innovative adaptive Phase 3 clinical trial (Press release, Oncolytics Biotech, JUN 22, 2023, View Source [SID1234632851]). 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 (PDAC).

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Precision Promise has a primary endpoint of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel or (2) mFOLFIRINOX. Each investigational therapy is subject to pre-specified interim analyses prior to proceeding to the registrational portion of the trial. This design, which was developed with guidance from the U.S. Food and Drug Administration, 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.

"We are delighted at being selected by the Precision Promise panel of experts," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "Our next step is to engage with stakeholders to finalize the protocol for Precision Promise’s pelareorep-containing investigational treatment so that we can enter into this study. We are thrilled to have the opportunity to leverage Precision Promise, which we expect will allow us to reduce the time and costs needed to reach a potential approval."

Julie Fleshman, JD, MBA, President and CEO of PanCAN commented, "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options. This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care."

Dr. Thomas Heineman, Chief Medical Officer of Oncolytics Biotech, commented, "Prior trials in pancreatic cancer show pelareorep-based combinations outperforming historical controls on key metrics such as one and two-year survival and objective response rate. In addition, mechanistic data from these studies highlight how pelareorep’s immunologic mechanism of action allows it to synergize with chemotherapy and checkpoint inhibition in this indication. I look forward to working with the Precision Promise team of investigators to seek to confirm the therapeutic value of pelareorep in a randomized setting so that we can potentially provide pancreatic cancer patients with a new treatment option."

Oncolytics expects to finalize the definitive agreements within the next 90 days and open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine, and nab-paclitaxel in early 2024.

Pelareorep in Pancreatic Cancer
Pelareorep’s inclusion in Precision Promise is supported by prior clinical data in pancreatic cancer that suggests it synergizes with checkpoint inhibition and chemotherapy. These prior data include phase 1/2 results showing a 69% objective response rate (ORR, n = 13) in a cohort of first-line advanced/metastatic PDAC patients treated with pelareorep combined with atezolizumab, gemcitabine, and nab-paclitaxel.

This compares to an average ORR of ~25% reported in relevant historical control trials1-4. In addition, a phase 2 study of pelareorep plus gemcitabine that included 29 evaluable chemotherapy-naïve pancreatic cancer patients showed a median overall survival (mOS) of 10.2 months and a one-year survival rate of 45%, compared to historical control trials showing mOS of approximately 6.7 months and one-year survival rates of approximately 20 – 22%, respectively1,5-6. A subsequent phase 2 study of pelareorep plus checkpoint inhibition without chemotherapy in pancreatic cancer patients who progressed after first-line treatment showed a 42% disease control rate (n = 12), post-treatment increases in PD-L1+ cells, and a correlation between clinical response and increased activation of anti-cancer CD8+ T cells.