Pelareorep Combo Drives Durable Responses in Third-Line Metastatic Anal Cancer

In new data from the phase 1/2 GOBLET trial (REO 029; Eudra-CT: 2020-003996-16), combining the oncolytic virus immunotherapy pelareorep (Reolysin) with atezolizumab (Tecentriq) has driven promising activity in a cohort of heavily pretreated patients with metastatic squamous cell anal carcinoma (SCAC).¹

In the third-line setting, where no FDA-approved therapies currently exist, the objective response rate (ORR) among 14 evaluable patients treated with the combination was 29% (n = 4). With 2 complete responses and 2 partial responses, this activity amounts to an approximately 3-fold improvement over the historical benchmarks in this setting, typically reporting ORRs of 10% or less. Additionally, the median duration of response (DOR) was approximately 17 months, underscoring the durability of benefit with this combination regimen.

“As we continue to analyze the GOBLET data, we are finding important trends that are helping to shape our clinical development strategy,” said Jared Kelly, CEO of Oncolytics Biotech, trial sponsor, in a news release.¹ “When you isolate to patients [with anal cancer] with [2] prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients’ lives who have no options.”

Metastatic disease accounts for approximately 10% to 20% of SCAC cases; against this backdrop, there is renewed optimism with the advent of immunotherapy and checkpoint blockade strategies such as pelareorep plus atezolizumab.² Pelareorep is an intravenously administered reovirus that selectively kills tumor cells and induces immunologic activity to enhance tumors’ response to checkpoint blockade therapy.³

Previous readouts with the combination in the second-line setting reported an ORR of 30% and median DOR of 15.5 months, representing marked improvements compared with the standard-of-care 13.8% ORR and 9.5-month median DOR.⁴ Taken together, these latest findings—spanning a patient cohort with advanced disease that had progressed after multiple lines of prior systemic therapy—represent a significant advancement in a historically difficult-to-treat setting.

Beyond anal cancer, pelareorep continues to show promise across multiple other gastrointestinal cancer indications, holding orphan drug designations from both the FDA and the European Medicines Agency (EMA) for pancreatic cancer.

About the GOBLET Study and Next Steps

The GOBLET study is an open-label, nonrandomized, multi-cohort study based in Germany evaluating the safety and efficacy of pelareorep plus the anti–PD-L1 checkpoint inhibitor atezolizumab with or without chemotherapy in patients with various metastatic gastrointestinal cancers, including pancreatic, colorectal, and anal cancers.²

A type C meeting between Oncolytics Biotech and the FDA is expected in the coming months to discuss next steps in the development of the combination for this indication, with the goal of advancing toward a registrational pathway to support potential accelerated approval.

REFERENCES

1. 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. January 12, 2026. Accessed January 19, 2026. https://tinyurl.com/y79zuw58

2. Rogers JE, Leung M, Johnson B. Metastatic or locally recurrent anal squamous cell carcinoma (SCAC): current clinical trial landscape and novel approaches. Cancer Manag Res. 2022;Volume 14:2065-2077. doi:10.2147/cmar.s331429

3. Collienne M, Loghmani H, Heineman TC, Arnold D. GOBLET: a phase I/II study of pelareorep and atezolizumab +/- chemo in advanced or metastatic gastrointestinal cancers. Future Oncol. 2022;18(26):2871-2878. doi:10.2217/fon-2022-0453

4. 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 January 19, 2026. https://tinyurl.com/bddjnrbt