FDA Grants Pelareorep Fast Track Designation in Advanced Anal Cancer

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

The designation was supported by encouraging efficacy results from the phase 1/2 GOBLET study, which evaluated pelareorep in combination with atezolizumab (Tecentriq) in patients with second-line or later metastatic SCAC. Among 20 evaluable patients, the combination achieved an objective response rate (ORR) of 30%, compared with a historical benchmark of 13.8% for single-agent retifanlimab-dlwr (Zynyz), the only FDA-approved immunotherapy in this setting.^1,2

Among the 6 responding patients, 2 achieved durable complete responses: 1 sustained beyond 2 years and another lasting 15 months. A third patient had an ongoing response at 64 weeks.² The median duration of response was 15.5 months and the 12-month overall survival rate was 82%.¹

More recently updated data from GOBLET Cohort 4, reported in January 2026, showed pelareorep plus atezolizumab achieved an ORR of approximately 29% as third-line therapy in 14 evaluable patients with heavily pretreated SCAC, including 2 complete responses and 2 partial responses. The median duration of response at that analysis was approximately 17 months, exceeding historical third-line outcomes in this population.³

No new safety signals were identified with pelareorep plus atezolizumab in the SCAC cohort of the GOBLET study. The tolerability profile was consistent with that established for atezolizumab, and no treatment-related toxicities led to discontinuation among the evaluable patients reported in October 2025.²

Study Design

GOBLET is an open-label, phase 1/2 multi-indication trial evaluating pelareorep in combination with atezolizumab across 5 cohorts of patients with advanced or metastatic gastrointestinal cancers.³ The SCAC cohort enrolled patients aged 18 years or older with confirmed advanced or metastatic unresectable SCAC and progression on or intolerance of prior systemic chemotherapy, an ECOG performance status of 0 or 1, a measurable lesion per RECIST v1.1, and no prior treatment with immune checkpoint inhibitors.²

The co-primary end points are ORR and disease control rate assessed at week 16 and safety; key secondary and exploratory end points include additional efficacy assessments and potential biomarker analyses. The study is being conducted at 17 centers in Germany and managed by AIO-Studien-gGmbH, with a protocol amendment submitted in September 2025 to open enrollment at US sites.³

The fast track designation in SCAC is the third gastrointestinal cancer designation granted to pelareorep by the FDA, following designations in KRAS-mutated metastatic colorectal cancer in February 2026 and pancreatic cancer in late 2022.¹

Pelareorep is an intravenously delivered oncolytic reovirus with a dual mechanism of action: it selectively replicates in tumor cells while simultaneously activating innate and adaptive anti-tumor immune responses, including upregulation of inflammatory cytokines, formation of tertiary lymphoid structures, and expansion of tumor-infiltrating lymphocytes.¹ The combination with checkpoint inhibitors is designed to convert immunologically cold tumors to hot, amplifying the immune response initiated by the virus.

"This fast track designation represents another important regulatory milestone for Oncolytics and reflects the significant progress we have made over the past twelve months in advancing pelareorep toward potential registration," Jared Kelly, chief executive officer of Oncolytics, stated in a press 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.

References

1. Oncolytics Biotech receives Fast Track designation for pelareorep in second-line and later anal cancer. News release. Oncolytics Biotech Inc. 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 Inc. October 28, 2025. Accessed July 20, 2026. https://tinyurl.com/5tn7b5ys

3. Oncolytics Biotech announces updated clinical data from GOBLET Cohort 4 demonstrating activity of pelareorep plus atezolizumab in third-line anal cancer. News release. Oncolytics Biotech Inc. January 12, 2026. Accessed July 20, 2026. https://tinyurl.com/mw5s3v2u

4. Goekkurt E, Heineman TC, Martens UM, et al. GOBLET platform study: preliminary safety and tumor response results for the relapsed anal carcinoma cohort in patients treated with pelareorep and atezolizumab. J Clin Oncol. 2025;43(4 suppl):6. doi:10.1200/JCO.2025.43.4_suppl.6