Reolysin and Tecentriq Treatment Elicit Responses in Third-Line Anal Cancer

Updated clinical data from GOBLET Cohort 4 demonstrated activity with the combination therapy Reolysin (pelareorep) plus Tecentriq (atezolizumab) in patients with third-line metastatic squamous cell anal carcinoma, according to a news release from Oncolytics Biotech® Inc., which noted that this patient population currently has no U.S. Food and Drug Administration (FDA)-approved treatment options.

The updated analysis shows that four of 14 evaluable patients treated with Reolysin and Tecentriq achieved objective responses, resulting in an objective response rate of approximately 29%. Responses included two complete responses and two partial responses. Importantly, the median duration of response reached nearly 17 months (67 weeks), highlighting both the depth and durability of benefit in a heavily pretreated population.

“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. “When you isolate to anal cancer patients with two 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.”

Reolysin Plus Tecentriq Shows Clinical Benefit

Third-line squamous cell anal carcinoma historically has very limited treatment options, with objective response rates typically around 10% or less and minimal durability, according to the press release. The approximately 29% objective response rate observed with Reolysin and Tecentriq almost triples the historical benchmark and suggests potential clinical activity.

These results compare favorably with outcomes in second-line squamous cell anal carcinoma, where the combination achieved a 30% ORR, which is more than double the 13.8% objective response rate seen with current standard-of-care therapy approved by the FDA. Median duration of response for second-line patients reached 15.5 months, compared with 9.5 months for standard therapy, indicating the combination’s potential to provide longer-lasting responses.

Registration Strategy and Potential FDA Accelerated Approval

Oncolytics plans to translate the GOBLET Cohort 4 findings into a registration study. If the objective response rate and duration of response are confirmed in a larger trial, the company believes the data could support an accelerated approval pathway. This approach aligns with regulatory precedent for rare cancers with no available therapies.

The company has received initial feedback from key opinion leaders and the FDA. Oncolytics plans to have a Type C meeting with the FDA in the first quarter of 2026 to discuss guidance for the registration study and potential approval strategy.

Unmet Need in Third-Line Anal Cancer

Metastatic squamous cell anal carcinoma is a rare and aggressive form of cancer, and patients in the third-line setting have typically exhausted multiple treatment options. Historically, these patients face limited efficacy with standard therapies and poor outcomes. This unmet need prompted the initiation of research with Reolysin plus Tecentriq, which has since demonstrated meaningful response rates and durable benefit, according to the news release.

As Oncolytics moves forward with its clinical development plan, the company aims to offer patients in need a treatment that addresses both the high unmet medical need and the lack of FDA-approved therapies in this indication. The combination’s observed responses and durability of effect suggest a path to improving outcomes for patients with advanced third-line metastatic squamous cell anal carcinoma.

Reference

1. "Oncolytics Biotech® Announces Updated Clinical Data from GOBLET Cohort 4 Demonstrating Activity of Pelareorep Plus Atezolizumab in Third-Line Anal Cancer," by Oncolytics Biotech® Inc. News release; Jan. 12, 2026.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

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