The Paul-Ehrlich-Institute (PEI) in Germany has granted approval to continue subject enrolment in cohort 5 of Oncolytics Biotech’s GOBLET trial, assessing pelareorep plus modified FOLFIRINOX in patients with newly diagnosed pancreatic ductal adenocarcinoma (PDAC).
This trial involves the combination with or without Genentech’s atezolizumab (Tecentriq).
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The approval follows a positive recommendation from the independent Data Safety Monitoring Board.
GOBLET cohort 5 includes a safety run-in for three subjects to assess the tolerability and safety of each treatment arm. Stage 1 of the Simon two-stage study will randomise 15 evaluable subjects to each arm, with the possibility of progression to stage 2 based on success criteria.
Stage 2 will involve enrolling an additional 17 evaluable subjects per arm. Blood and tumour samples from patients will be collected throughout the study for translational evaluations.
Initial efficacy outcomes from cohort 5 are anticipated in the second half of this year.
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By GlobalDataThe Phase I/II GOBLET study is a multiple indication trial focusing on advanced or metastatic gastrointestinal tumours. It is being carried out across 17 centres in Germany and managed by AIO.
Objective response rate and safety are the co-primary endpoints, with key secondary and exploratory endpoints including further efficacy assessments and biomarker evaluations.
The study encompasses five distinct treatment groups, each targeting different cancer types and stages, with the potential for cohorts meeting stage 1 efficacy criteria to advance to stage 2.
Oncolytics Biotech chief medical officer Thomas Heineman said: “Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer.
“Encouraging tumour response rates observed in an earlier cohort of the GOBLET study underscore pelareorep’s promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy.”
