Oncolytics to test immunotherapy against aggressive pancreatic cancer
Pivotal Phase 3 trial of pelareorep expected to launch in 2026
Oncolytics Biotech has cleared a significant hurdle in the U.S. to advance its unique viral immunotherapy, pelareorep, to a pivotal Phase 3 trial for advanced pancreatic cancer.
The company has received clearance from the U.S. Food and Drug Administration (FDA) to launch a trial for pelareorep, an oncolytic virus designed to prime the immune system against tumors. The study will test pelareorep alongside standard-of-care therapy as a first-line treatment for aggressive pancreatic ductal adenocarcinoma (PDAC), with the potential for an accelerated registration based on an interim analysis.
“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,” Jared Kelly, Oncolytics’ CEO, said in a company press release. “We are now completing the administrative activities necessary to initiate the study, including finalizing the protocol, generating supporting documents, and site selection. We also plan to announce the lead principal investigator once these preparations are complete.”
How does pelareorep work?
Pelareorep is an oncolytic virus designed to infect and kill cancer cells, triggering the body’s immune system also to attack the cancer. The treatment is delivered through intravenous infusion and is systemically active throughout the body.
Oncolytics is conducting the Phase 1/2 GOBLET trial testing pelareorep in combination with standard-of-care therapy, where appropriate, in people with PDAC and other types of digestive cancer at centers in Germany.
An earlier part of the trial tested pelareorep in combination with Tecentriq (atezolizumab) and the chemotherapy medicines gemcitabine and nab-paclitaxel (GnP), in people with PDAC. Atezolizumab is a checkpoint inhibitor, a type of immunotherapy that activates T-cells and directs them to attack cancer cells.
This treatment combination resulted in a 62% objective response rate, a measure used to determine the proportion of patients in whom the tumor shrinks or disappears. The rate is more than double the response seen in other trials using different treatments, according to the company. The regimen previously received FDA fast-track designation for the treatment of advanced/metastatic pancreatic cancer.
In another part of the GOBLET trial, dubbed Cohort 5, pelareorep is being tested in combination with a different chemotherapy regimen called modified FOLFIRINOX (mFOLFIRINOX), with or without Tecentriq. This chemotherapy regimen uses four different anti-cancer drugs: leucovorin, fluorouracil, irinotecan, and oxaliplatin.
The pivotal Phase 3 study will include a control group receiving GnP, an experimental group receiving pelareorep and GnP, and an additional potential group receiving pelareorep, GnP, and a checkpoint inhibitor.
Pelareorep has been combined with several checkpoint inhibitors, including Tecentriq, Keytruda (pembrolizumab), Opdivo (nivolumab), and Zynyz (retifanlimab). The final checkpoint inhibitor choice is subject to internal and external discussions.
The trial’s primary goal is to evaluate patients’ overall survival and survival without disease progression. Secondary measures include objective treatment response.
Pelareorep has also been tested for other types of cancer, including advanced breast cancer, anal and colorectal cancer, lung cancer, and skin cancer.
