RE:RE:RE:RE:RE:RE:RE:How does Accelerated Approval work On October 2023 ONCY reported on multiple surrogate endpoints (highlighted in red below) of the Goblet-1 Phase 2 pancreatic trial (PDAC) involving pelareorep in combination with the ICI atezolizumab. Summary of Data and Findings from the PDAC Arm of the Phase 1/2 GOBLET Study:
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
https://oncolyticsbiotech.com/press_releases/oncolytics-presents-positive-updated-pancreatic-cancer-data-from-goblet-phase-1-2-study-at-esmo/