On October 16, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, reported the publication of two abstracts for posters to be presented during the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, taking place from October 20th to 24th at the IFEMA Madrid Conference Center in Madrid, Spain (Press release, Oncolytics Biotech, OCT 16, 2023, View Source [SID1234636009]).
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Abstracts Overview
Abstract / Poster Title Pelareorep (pela) + atezolizumab (atezo) and chemotherapy in first-line (1L) advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Results from the GOBLET study
Final Publication Number (FPN) 1623P
Poster Date October 23, 2023
Abstract / Poster Title Pelareorep + atezolizumab and chemotherapy in third-line (3L) metastatic colorectal cancer (mCRC) patients – Interim results from the GOBLET study
Final Publication Number (FPN) 619P
Poster Date October 22, 2023
Abstracts Summaries
Abstract 1623P
•The GOBLET Phase 1/2 Simon two-stage basket study was designed to evaluate pelareorep in combination with the PD-L1 inhibitor atezolizumab (atezo) and chemotherapy in patients with different solid tumors. In the first stage of the pancreatic ductal adenocarcinoma (PDAC) cohort, 13 evaluable patients were enrolled (including 92% with metastatic disease, 69% in the liver). Primary objectives were safety and efficacy, measured by Stage 1 success criterion of >3 confirmed responses (PDAC segment). T cell receptor sequencing (TCR-seq) was also performed during the course of treatment.
•Updated data from the study showed that 8 of 13 evaluable patients had a partial response (PR) and 3 had stable disease (SD) for an objective response rate (ORR) of 62% (53% confirmed with two scans) and a clinical benefit rate (CBR) of 85%. As of the data cut-off (January 19, 2023), the median duration of response was 6.0 months, the 6-month progression-free survival (PFS) rate was 72.9%, and the 6-month overall survival (OS) rate was 82.1%. T cell receptor sequencing (TCR-seq) showed an expansion of new and pre-existing T-cell clones. No safety signals were observed. Updated efficacy and TCR-seq results will be presented at ESMO (Free ESMO Whitepaper); final PFS and OS are pending.
•The authors concluded from these data that the combination of pelareorep, atezo and chemotherapy was well-tolerated and that the ORR exceeded the pre-specified success criterion. The authors also noted that these data compare favorably with ORRs from prior first-line PDAC trials.
Abstract 619P
•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 (Free ESMO Whitepaper).
•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 1st line advanced/metastatic pancreatic cancer patients (n=12);
2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);
3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
4.Pelareorep in combination with atezolizumab in 2nd 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.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.