Oncolytics Biotech To Present Two Posters on the Pelareorep-Based GOBLET Study at ESMO 2023 - Seite 2

• This abstract evaluated pelareorep combination therapy (pelareorep plus atezo plus chemotherapy, trifluridine/tipiracil) in third-line metastatic colorectal cancer patients with microsatellite stable (MSS) disease. In the first stage of this segment, 15 evaluable patients were enrolled, and the primary objectives were safety and efficacy, measured by Stage 1 success criterion of >4 patients with SD at week 16. TCR-seq was also performed during the course of the treatment cycle to assess the treatment effect on the T cell repertoire.
• Interim data from the study showed that 5 of 15 patients had SD as their best response, including 4 with SD at week 16, and 10 patients had progressive disease (PD). The CBR, defined as stable disease or better, was 33%. Translational research, including TCR-seq, showed an expansion of new and pre-existing T-cell clones. No safety signals were observed. Updated efficacy (PFS and OS) and TCR-seq results will be presented at ESMO.
• The authors concluded from these data that the pelareorep combination was well-tolerated and the primary efficacy success criterion was met. The authors believe that protective immune responses were initiated in these patients but that they may have been too immunocompromised or have insufficient time before disease progression to fully benefit from the pelareorep-based immunotherapy.

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 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints 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 1^st line advanced/metastatic pancreatic cancer patients (n=12);

1. Pelareorep in combination with atezolizumab in 1^st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

1. Pelareorep in combination with atezolizumab and TAS-102 in 3^rd line metastatic colorectal cancer patients (n=14); and

1. Pelareorep in combination with atezolizumab in 2^nd line advanced and unresectable anal cancer patients (n=10).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.