Update alert for potential first-line pancreatic cancer registration study

Image Credit: Pancreatic Cancer Action Network

Announcement

Oncolytics Biotech Inc., a leading clinical-stage immunotherapy company, is establishing pelareorep, which has prompted an update on its offered design of its intended registration-directed clinical trial in the first-line pancreatic ductal adenocarcinoma (PDAC). The company is planning to visit the US Food and Drug Administration (FDA) in mid-November 2025 to enhance study details. The company has long served in the advancement of pelareorep in merger with chemotherapy and/or checkpoint inhibitors in breast cancers and metastatic pancreatic cancer.

The company has succeeded with its development programs in both checkpoint inhibitors. With this update, the oncology treatments will have a new advancement and an improvement in precision medicine itself. This update is proof of the study’s intensified take on and seriousness about the extreme condition. Further, the study will achieve excellence with the efforts of the oncolytics, promising development in the oncology area, further accelerating the vast healthcare market.

Major elements of the offered registration study

The three-layered design element applicable to patients will be randomized to receive GnP pelareorep + checkpoint inhibitor (CPI), GnP + pelareorep, or gemcitabine + nab-paclitaxel (GnP) control arm. The primary endpoint of this study is to achieve overall survival (OS). The intention is to meet accuracy, following which the trial will initiate to address statistical prominence between the control arm and investigational arm. Another aspect of the study is to execute the planned interim analysis. The interim efficacy analysis will be integrated to allow early assessment of the potential clinical benefit.

This offered design illustration is further strengthened by a wide, post-hoc clinical analysis, which observed that the integration of pelareorep to chemotherapy has excellently achieved an estimated 22% two-year survival rate. Following, in comparison to only 9% for patients treated with chemotherapy alone, proved to be a positive impact in the historical third-party benchmarks.

The chief executive officer of Oncolytics, Jared Kelley, said, “We are thrilled to accelerate and shape this potential registration-directed study in first-line pancreatic cancer with a three-arm powered design. By examining pelareorep with chemotherapy and in merger with checkpoint inhibition, we look forward to advocating this program to serve valuable data for regulators and patients alike. We believe that capable partners will identify the possibilities that this trial design includes to further develop pelareorep as the first ever approved immunotherapy in first-line pancreatic cancer. This is a transformative, brilliant milestone in oncology.”