BioNTech has terminated a mid-stage trial of its personalized mRNA cancer vaccine in colorectal cancer after an independent monitoring board identified a numerical imbalance in overall survival between the two treatment groups and concluded that continuing would not change the efficacy result.
The decision, announced by the company and made in consultation with development partner Genentech, ends the Phase 2 BNT122-01 trial of autogene cevumeran. The trial enrolled patients whose Stage II high-risk or Stage III colorectal cancer had been surgically removed but who still had circulating tumor DNA in their blood, a signal that microscopic disease remains. It was designed to enroll roughly 327 people, with disease-free survival as the primary endpoint and overall survival among the secondary measures.
