FDA Grants Fast Track Designation to Pelareorep-Based Combo in Pretreated SCAC

The FDA has granted fast track designation to pelareorep in combination with a checkpoint inhibitor for the treatment of patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on or were intolerant to 1 or more prior lines of systemic therapy.¹

The designation was supported by findings from the SCAC cohort (n = 20) of the phase 1/2 GOBLET (NCT07280377) study, in which pelareorep plus atezolizumab (Tecentriq) generated an objective response rate (ORR) of 30%, more than double the historical benchmark of 13.8% reported for the only FDA-approved second-line immunotherapy in this setting.²

The combination produced a median duration of response (DOR) of 15.5 months vs 9.5 months for the current standard of care (SOC). The 12-month overall survival (OS) rate was 82% compared with 45.7% for current SOC.¹

“This fast track designation represents another important regulatory milestone for Oncolytics [Biotech] and reflects the significant progress we have made over the past 12 months in advancing pelareorep toward potential registration,” Jared Kelly, chief executive officer of Oncolytics Biotech, stated in a news release.¹ “During that time, we have received fast track designation in both metastatic colorectal cancer and squamous cell anal carcinoma, achieved important FDA alignment on registrational development strategies, strengthened our intellectual property portfolio, and continued to generate compelling clinical data across our gastrointestinal oncology programs. Our April meeting with the FDA provided important clarity regarding a potential registrational pathway for pelareorep in second-line and later anal cancer, reinforcing our confidence in the program and our strategy to address an area of significant unmet need. We believe these milestones continue to de-risk our development programs while positioning the company to deliver meaningful value for patients and shareholders.”

What is the mechanism of action of pelareorep?

Pelareorep is an intravenously delivered, systemically active investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive antitumor immune responses, according to Oncolytics Biotech. This activity includes upregulation of key inflammatory cytokines that result in the formation of tertiary lymphoid structures and expansion of tumor-infiltrating lymphocytes, and it is designed to convert immunologically cold tumors to hot tumors.

How was the GOBLET trial designed?

GOBLET was a phase 1/2, multiple-indication study evaluating pelareorep in combination with checkpoint inhibitors and standard therapies in patients with advanced or metastatic gastrointestinal tumors; The trial was conducted at 17 centers in Germany after initiating in 2021.³

The study enrolled patients across 5 treatment groups spanning pancreatic, colorectal, and anal cancer indications. All patients needed to have at least 1 measurable lesion per RECIST 1.1 criteria, an ECOG performance status of 0 or 1, and adequate hematological, renal, and hepatic function. Patients in the SCAC cohort also needed a life expectancy of at least 3 months, and patients were not allowed to enroll if they had a prior HIV infection with a CD4-positive T-cell count of less than 300 cells/µL.

In the SCAC cohort, patients with second-line or later advanced or unresectable disease received pelareorep in combination with atezolizumab.

The primary end point was ORR. Key secondary and exploratory end points included progression-free survival, disease control rate, DOR, and OS.

References

1. Oncolytics Biotech receives fast track designation for pelareorep in second-line and later anal cancer. Oncolytics Biotech. News release. July 20, 2026. Accessed July 20, 2026. https://ir.oncolyticsbiotech.com/press_releases/oncolytics-biotech-receives-fast-track-designation-for-pelareorep-in-second-line-and-later-anal-cancer/
2. Oncolytics Biotech reports updated anal cancer data showing objective response rate more than double the current standard of care. News release. Oncolytics Biotech. October 28, 2025. Accessed July 20, 2026. https://ir.oncolyticsbiotech.com/press_releases/oncolytics-biotech-reports-updated-anal-cancer-data-showing-objective-response-rate-more-than-double-the-current-standard-of-care/
3. A study in advanced or metastatic gastrointestinal cancers exploring treatment combinations with pelareorep and atezolizumab (GOBLET). ClinicalTrials.gov. Updated May 19, 2026. Accessed July 20, 2026. https://clinicaltrials.gov/study/NCT07280377