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Oncolytics Biotech® Reports Completion of Initial Safety Phase Enrollment for GOBLET Trial's New Pancreatic Cancer Cohort
Early safety and tolerability results from six randomized patients support continued enrollment of pelareorep combined with modified FOLFIRINOX, with or
About this update from Oncolytics Biotech Inc.
[{"type":"text","content":"Early safety and tolerability results from six randomized patients support continued enrollment of pelareorep combined with modified FOLFIRINOX, with or without atezolizumab\nThe study will begin with 30 patients, with an option to expand to an additional 34 participants\nSAN DIEGO and CALGARY, AB, Dec. 3, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that the Data Safety Monitoring Board (DSMB) has recommended continued enrollment in Cohort 5 of the GOBLET study following their review of initial safety data. Enrollment in this cohort will resume pending final approval from the Paul Ehrlich Institute (PEI), Germany's medical regulatory body. Additional updates are expected in 2025, with safety data anticipated in the first half and initial efficacy results in the second half.\n\n \n \n \n \n \n \n\n \nThe GOBLET study is a Phase 1/2 randomized, open-label, multicenter trial using a Simon two-stage design to evaluate treatments across multiple gastrointestinal cancers. In cohort 5, the study is assessing pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab (Tecentriq®), in patients with newly diagnosed pancreatic ductal adenocarcinoma (PDAC). This cohort is funded by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program designed to speed up the development of new pancreatic cancer treatments.\n\"We see a promising opportunity for pelareorep to improve treatment options for PDAC patients,\" said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. \"The current standard of care is primarily chemotherapy, such as gemcitabine + nab-paclitaxel or mFOLFIRINOX. Pelareorep has already shown synergy with gemcitabine, nab-paclitaxel, and atezolizumab in GOBLET Cohort 1, and demonstrating efficacy with mFOLFIRINOX would further establish its potential to benefit PDAC patients. This study also builds on Cohort 1 by evaluating pelareorep's ability to work with checkpoint inhibitors, which would be a major advance, especially as immune therapies provide little benefit in most patients with this 'cold' tumor.\"\nAbout GOBLET Cohort 5 The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate new...