On November 9, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY, Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, reported the presentation of positive, interim results from the Phase 1/2 GOBLET study evaluating the combination of pelareorep and atezolizumab in second-line patients with unresectable squamous cell carcinoma of the anal canal (SCCA) by Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, in an oral presentation at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) 2023, taking place in Rome, Italy (Press release, Oncolytics Biotech, NOV 9, 2023, View Source [SID1234637408]).

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"The positive interim data from the anal cancer cohort of the Phase 2 GOBLET study presented today at the IMACC meeting is very exciting for our company and the potential of pelareorep in gastrointestinal cancers. These results met the pre-specified success criteria for the cohort and exceeded the results from historical controls in similar patient populations1-7," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "I am especially pleased to note that this is the third indication from the GOBLET study in a row to meet its success criteria and the fourth indication combining pelareorep and atezolizumab to present positive data, further validating the potential clinical benefit of this combination and opening the door to another potential registrational pathway for pelareorep. Furthermore, we’ve seen another complete response in an indication where checkpoint inhibitor therapy alone has had limited success historically, which bodes well for the potential of pelareorep to work synergistically with multiple immunotherapies in multiple tumor types."

Dr. Arnold commented, "Current treatment options for SCCA are poor, with no defined standard of care for patients who have progressed after first-line therapy. Oncolytics is developing a solid compendium of clinical data showing consistent positive results from the combination of pelareorep and the checkpoint inhibitor atezolizumab. We are particularly pleased by the promising data presented today because they show that pelareorep may have the potential to offer the hope of a new, effective treatment option for patients with advanced SCCA."

Summary of Interim Data and Findings from the SCCA Arm of the Phase 1/2 GOBLET Study:

Tumor Responses: Interim Objective Response Rate (ORR) of 37.5% based on one patient with a complete response (ongoing at 12 months) and two patients with a partial response (one at week 8, one ongoing at week 16)

Safety: No safety signal has been observed, consistent with previously reported cohorts from the GOBLET study

"We are very pleased by the positive data from patients with SCCA presented at IMACC. These results, which demonstrate an almost a 3X improvement compared to data from like studies evaluating checkpoint inhibitors in patients with more than one prior line of therapy1-7, provide further support for pelareorep’s ability to generate an effective immune response and improve objective response rates," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "These data, coupled with the positive data for pancreatic and colorectal cancer, will be instrumental in defining and prioritizing the registrational pathway for pelareorep in gastrointestinal cancers."

GOBLET Study SCCA Patient Overview:
Patients in the SCCA cohort, presented at IMACC 2023, are undergoing second-line (2L) or later treatment with a combination of pelareorep and atezolizumab. Ten patients are to be enrolled in the first stage of the study, 8 patients were evaluable based on an October 23, 2023 data cut-off date. Two or more responses out of the first ten enrolled patients are required to satisfy the Simon two-stage success criteria.