Oncolytics Biotech Receives FDA Fast Track Designation for KRAS Mutant Colorectal Cancer

Oncolytics Biotech announced that the U.S. Food and Drug Administration has granted Fast Track Designation to pelareorep in combination with bevacizumab and leucovorin, fluorouracil, irinotecan for the treatment of patients with KRAS mutant, microsatellite-stable metastatic colorectal cancer in the second-line setting. As part of the Company's increased focus on gastrointestinal cancer and analysis of the existing colorectal data set in the fall, the Company applied for and has now received Fast Track Designation. The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care in this patient population. In addition, pelareorep combination therapy was associated with a median progression-free survival of 16.6 months, compared to 5.7 months with SOC, and a median overall survival of 27 months, compared to 11.2 months with SOC. Oncolytics expects to initiate a controlled clinical study in second-line KRAS-mutant MSS mCRC comparing standard-of-care therapy alone versus standard-of-care plus pelareorep. The first clinical site is expected to be activated in March, with up to 10 additional sites anticipated to open shortly thereafter. Interim data from the study are expected by year-end. Further details regarding the study design and milestones are forthcoming.