Dr. Matt Coffey reports

ONCOLYTICS ACHIEVES SUCCESS CRITERIA FOR EFFICACY IN THE THIRD-LINE COLORECTAL CANCER COHORT OF THE GOBLET STUDY

Oncolytics Biotech Inc. has released the poster presentation of interim results from the phase 1/2 Goblet study evaluating a combination treatment of pelareorep in patients with third-line (3L) metastatic colorectal cancer (CRC) regardless of microsatellite instability (MSI) status at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.

"The results presented at ESMO met the criteria to advance the study to the next stage, with four of 14 enrolled patients demonstrating stable disease at week 16. These data demonstrated a 40-per-cent overall disease control rate and provided further encouraging data for pelareorep," said Dr. Matt Coffey, president and chief executive officer of Oncolytics. "In a patient population that had failed multiple rounds of treatment, we continue to see pelareorep's ability to synergize with atezolizumab by generating an immune response, including the expansion of T-cell clones. The translational data from this cohort are consistent with the observed clinical response, providing further support for pelareorep's mechanism of action as a potential backbone immunotherapy for patients with gastrointestinal and other forms of cancer."

"We designed the Goblet study to evaluate pelareorep's ability to improve clinical outcomes in different gastrointestinal cancers, including at different disease stages, and to better understand pelareorep's mechanism of action by generating strong translational data. The data from this arm of the study demonstrate that pelareorep is taken up by tumour cells and stimulates T-cell expansion even in heavily pretreated colorectal cancer patients," said Dr. Thomas Heineman, MD, PhD, chief medical officer at Oncolytics. "These patients demonstrated a 40-per-cent disease control rate, a progression-free survival of 2.8 months, a median overall survival of eight months and a 12-month survival rate of 33 per cent, exceeding historical results. These findings are encouraging given that exhaustion of tumour-infiltrating lymphocytes, resulting from late stage of disease and extensive prior chemotherapy, may have limited their ability to expand in response to treatment. Notably, this is the second Goblet study cohort in a row that has met its success criteria, further supporting pelareorep's ability to synergize with atezolizumab. These data also support pelareorep's immunologic mechanism of action and will inform our plans for further development."

Goblet study 3L metastatic CRC patient overview

Patients in the CRC cohort, presented at ESMO 2023, are undergoing third-line treatment with a combination of pelareorep, atezolizumab and trifluridine/tipiracil. The 15 evaluable patients enrolled in the first stage of the study have been evaluated based on a Sept. 18, 2023, data cut-off date. The enrolled patient population included patients with an ECOG score of less than or equal to 1 and confirmed colorectal cancer, regardless of microsatellite instability status.

Poster information

Poster title: Pelareorep + atezolizumab and chemotherapy in third-line (3L) metastatic colorectal cancer (mCRC) patients -- interim results from the Goblet study

Final publication No. (FPN): 619P

Poster date: Oct. 22, 2023

About Goblet

The Goblet (gastrointestinal tumors exploring the treatment combinations with the oncolytic reovirus pelareorep and anti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centres in Germany and is being managed by AIO-Studien-gGmbH. The co-primary end points of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory end points include additional efficacy assessments and evaluation of potential biomarkers (T-cell clonality and CEACAM6). The study employs a Simon two-stage design with stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

• Pelareorep in combination with atezolizumab, gemcitabine and nab-paclitaxel in first-line advanced/metastatic pancreatic cancer patients;
• Pelareorep in combination with atezolizumab in first-line MSI-high metastatic colorectal cancer patients;
• Pelareorep in combination with atezolizumab and TAS-102 in third-line metastatic colorectal cancer patients;
• Pelareorep in combination with atezolizumab in second-line advanced and unresectable anal cancer patients.

Any cohort showing an ORR above a prespecified threshold in stage 1 may be advanced to stage 2 and enroll additional patients.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumour phenotype -- turning cold tumours hot -- through innate and adaptive immune responses to treat a variety of cancers.

We seek Safe Harbor.