RE:RE:RE:RE:Panc Biomarker Presentation at ASCO GI 18-20 Jan 2024 Oncolytics Biotech® Announces Clinical & Biomarker Data Demonstrating Clinical Proof-of-Concept for Pelareorep-Checkpoint Inhibitor Combination in Pancreatic Cancer - May 2021
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 biomarker, safety, and efficacy study in advanced or metastatic GI tumors. The study will be conducted at 25 centers in Germany. The primary endpoint of the study is safety, with overall response rate and biomarker evaluation (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned for enrollment across four separate cohorts: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-clinical-and-biomarker-data-demonstrating-clinical-proof-of-concept-for-pelareorep-checkpoint-inhibitor-combination-in-pancreatic-cancer-301295729.html In October 2023 ONCY's Phase 1/2 GOBLET study evaluating pelareorep-based combination therapy in patients with pancreatic ductal adenocarcinoma reported positive and consistent data on pelareorep, 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.
Summary of Data and Findings from the PDAC Arm of the Phase 1/2 GOBLET Study showed:
Tumor Responses: Consistent with the abstract, data from the study outlined patient responses, including:
- Objective Response Rate (ORR) of 62% (54% confirmed by two or more scans)
- A Disease Control Rate (DCR) of 85%
Survival data: Evaluated based on 4 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%
- Interim median overall survival (OS) was 10.6 months
T-Cell Populations: Analysis of changes of T-cell clones and tumor-infiltrating lymphocytes (TILs) showed:
- Mean baseline TIL cell levels of 22%
- 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 tumor response
Safety: The treatment combination has been well tolerated with no safety concerns
“The data from this study show a correlation between the expansion of TIL-specific clones and tumor response, which provides compelling support for the use of pelareorep-based therapies in immunologically “cold” tumors. 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,”
https://oncolyticsbiotech.com/press_releases/oncolytics-presents-positive-updated-pancreatic-cancer-data-from-goblet-phase-1-2-study-at-esmo/