Dr. Matt Coffey reports

ONCOLYTICS PRESENTS POSITIVE UPDATED PANCREATIC CANCER DATA FROM GOBLET PHASE 1/2 STUDY AT ESMO

Oncolytics Biotech Inc. has presented its poster of positive, updated results from the phase 1/2 Goblet study evaluating pelareorep-based combination therapy in patients with pancreatic ductal adenocarcinoma (PDAC) at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.

"We are very pleased to share such positive and consistent data on pelareorep from the PDAC arm of the Goblet study, including an impressive overall response rate, 7.2 months of median progression-free survival, interim median overall survival of 10.6 months, and expansion of both pre-existing and new T-cell clones. These data build upon results from previous studies showing the clinical benefit of pelareorep combination therapy in PDAC and support the decision to move to a licensure-enabling study in pancreatic cancer," said Dr. Matt Coffey, president and chief executive officer of Oncolytics. "Everything we do at Oncolytics is focused on advancing the development of our immunotherapy candidate, pelareorep, with a goal of providing improved care and longer survival for patients with pancreatic cancer and other tumour types. The data we are presenting at ESMO provide a solid foundation as we advance our pancreatic cancer program through the Precision Promise phase 3 trial in this indication."

Summary of data and findings from the PDAC arm of the phase 1/2 Goblet study:

Tumour responses: Consistent with the abstract, data from the study outlined patient responses, including:

• An objective response rate (ORR) of 62 per cent (54 per cent confirmed by two or more scans);
• A disease control rate (DCR) of 85 per cent.

Survival data: Survival was evaluated based on four parameters, including:

• Median duration of response was 5.7 months;
• Median progression-free survival (PFS) was 7.2 months;
• Interim 12-month survival rate was 46 per cent;
• Interim median overall survival (OS) was 10.6 months.

T-cell populations: Analysis of changes of T-cell clones and tumour-infiltrating lymphocytes (TILs) showed:

• Mean baseline TIL cell levels of 22 per cent;
• Expansion of pre-existing and new T cell clones, including the expansion of TIL-specific clones;
• A correlation between the expansion in the blood of TIL-specific clones and tumour response.

Safety: The treatment combination has been well tolerated with no safety concerns:

• Most common Grade 3 and Grade 4 treatment-related adverse events were related to red and white blood cell counts (anemia, neutropenia and decreased neutrophil counts).

"The data from this study show a correlation between the expansion of TIL-specific clones and tumour response, which provides compelling support for the use of pelareorep-based therapies in immunologically cold tumours. In particular, these data, along with the impressive clinical results, support the ability of pelareorep/checkpoint inhibitor combination therapies to meaningfully improve treatment responses in diseases like pancreatic cancer that have resisted immune-based therapeutic approaches," said Dr. Thomas Heineman, MD, PhD, chief medical officer at Oncolytics. "Given the urgent need for better treatment options for patients with pancreatic cancer, we are especially gratified to observe that results from the combination regimen we are evaluating surpassed published historical results. We look forward to beginning the Precision Promise pivotal phase 3 platform trial as soon as possible, and we wish to express our sincere gratitude to all the patients, caregivers and study site personnel associated with the Goblet trial."

Goblet study PDAC patient overview

Patients in the PDAC cohort, presented at ESMO 2023, are undergoing first-line treatment with a combination of pelareorep, atezolizumab, gemcitabine and nab-paclitaxel. The 13 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 93 per cent of patients with metastatic disease (69 per cent with liver metastases) and baseline ECOG scores of 0 (31 per cent) and 1 (69 per cent), with an average age of 61.2 years.

Poster information

Poster title:  pelareorep (pela) plus atezolizumab (atezo) and chemotherapy in first-line (1L) advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients -- results from the Goblet study

Final publication No. (FPN):  1623P

Poster date:  Oct. 23, 2023

About Goblet

The Goblet (gastrointestinal tumours 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 tumours. 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:

1. Pelareorep in combination with atezolizumab, gemcitabine and nab-paclitaxel in first-line advanced/metastatic pancreatic cancer patients (n equal to 12);
2. Pelareorep in combination with atezolizumab in first-line MSI-high (microsatellite instability) metastatic colorectal cancer patients (n equal to 19);
3. Pelareorep in combination with atezolizumab and TAS-102 in third-line metastatic colorectal cancer patients (n equal to 14);
4. Pelareorep in combination with atezolizumab in second-line advanced and unresectable anal cancer patients (n equal to 10).

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.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances toward registrational studies in metastatic breast cancer and pancreatic cancer.

We seek Safe Harbor.