Oncolytics Biotech has announced impressive clinical data in metastatic colorectal cancer that could accelerate the company's path to registration.
The results show the oncolytic virus pelareorep achieved a median progression-free survival of 16.6 months compared with only 5.7 months with standard treatments, representing approximately 2.5 times longer disease control in KRAS mutant colorectal cancer patients.
Additionally, overall survival reached 27.0 months compared with the typical 11.2 months, representing a dramatic improvement in one of oncology's most challenging areas.
This data comes from the REO 022 trial testing pelareorep with FOLFIRI and bevacizumab in second-line treatment.
"These studies validate pelareorep's mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics.
"Given pelareorep's activity in this difficult-to-treat cancer and other RAS-mutated gastrointestinal (GI) tumours, including metastatic pancreatic and anal cancers, we believe pelareorep is positioned to become the premier platform immunotherapy in the GI space."
The company plans to work with regulators to define a path toward registration in KRAS mutant colorectal cancer.
The US Food and Drug Administration's (FDA) unprecedented wave of Breakthrough Therapy Designations during August has accelerated development timelines for cancer treatments and these recent designations are creating momentum for companies that are advancing breakthrough oncology platforms such as Oncolytics.
The results extend beyond survival numbers. Translational studies have also confirmed that pelareorep actually replicates inside tumour cells whilst activating immune responses, including dendritic cell maturation and CD8+ T cell activation.
This proves the drug's ability to transform "cold" tumours into "hot" targets that are responsive to immunotherapeutic treatments.
Pelareorep represents a systemically delivered oncolytic virus that reprogrammes a patient's immune system against cancer.
Unlike traditional chemotherapy that attacks cells indiscriminately, this immunotherapy selectively targets cancer whilst mobilising the body's natural defences.
In parallel, the company is advancing toward registration-enabling trials in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), where survival data has proven equally compelling.
Clinical results showed a 21.9% two-year overall survival rate compared with the 9.2% historical benchmark for standard chemotherapy protocols.
Checkpoint inhibitors currently lack approval for pancreatic cancer; however, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors, thus it could unlock immunotherapy effectiveness in historically resistant tumours.
Additionally, Oncolytics recently provided updated safety data for pelareorep, with the most common side effects being mild flu-like symptoms. Data also showed pelareorep does not modify the safety profile of established chemotherapy regimens.
The company has confirmed ongoing discussions with the FDA to finalise pivotal study parameters for pancreatic cancer, targeting potential trial initiation activities by Q4 2025.
Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes.
The company's dual-track approach in gastrointestinal cancers, combined with an experienced leadership team and FDA Fast Track designation, suggests pelareorep could soon transition from a clinical promise to a commercial reality.