Oncolytics schedules Type C FDA meeting for pelareorep single-arm study in anal cancer

ONCOLYTICS BIOTECH INC

FDA meeting set for April 16, 2026 to discuss single-arm pivotal study of pelareorep + checkpoint inhibitor in SCAC.
Proposed enrollment of 60-70 second-line+ patients with no approved therapy; primary endpoint ORR for full approval.
GOBLET Cohort 4 achieved ~30% ORR and median DOR of 17 months vs real-world 10-14% ORR and 9.5 months DOR.
SCAC is a rare cancer with ~54,000 annual global cases; anal cancer market projected to reach $2.3B by 2035.

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