Oncolytics Biotech, Inc. (NASDAQ:ONCY) shares are up on Monday as the company reported promising durability data for its investigational immunotherapy, pelareorep, in treating metastatic colorectal cancer.
• Oncolytics Biotech shares are powering higher. What’s behind ONCY gains?
Durability Metrics Outpace Historical Benchmarks
Oncolytics Biotech announced that pelareorep demonstrated a 19.5-month median duration of response in second-line KRAS-mutant microsatellite-stable colorectal cancer patients, significantly outperforming historical benchmarks of four to six months.
The company is actively engaging with the FDA to explore a potential accelerated approval pathway based on these encouraging results.
Additional data from the study include an objective response rate of 33% for patients receiving pelareorep, bevacizumab, and FOLFIRI, tripling the 6%-11% for the standard of care.
CEO Highlights Durability Signal and Approval Pathway
“We believe these data demonstrate a compelling durability signal for pelareorep in colorectal cancer,” said Jared Kelly, CEO of Oncolytics.
“A 19.5-month median duration of response in second-line patients — representing a three- to four-fold improvement over historical expectations — highlights pelareorep’s potential to deliver sustained benefit in a population with few effective options. We believe these results support a path toward accelerated approval in second-line RAS-mutant MSS metastatic colorectal cancer, and we are actively engaging with the FDA to align on a regulatory strategy leveraging our ongoing randomized study.”
In April, Oncolytics Biotech announced a Type C meeting with the U.S. Food and Drug Administration (FDA) resulted in alignment on the design of a pivotal clinical study to support approval of pelareorep for unresectable metastatic squamous cell carcinoma of the anal canal.
ONCY Stock Price Activity: Oncolytics Biotech shares were up 4.53% at 91 cents at the time of publication on Monday, according to Benzinga Pro data.
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