BioNTech-Genentech halts colorectal cancer vaccine trial after higher death rate in vaccine arm

BioNTech and Genentech stopped a phase 2 trial of their personalized mRNA vaccine BNT122 in patients with stage 2 or 3 colorectal cancer after an independent data safety monitoring board found more deaths in the vaccine group than in the observation group.

The trial was designed to see if the vaccine, customized to each patient’s tumor mutations, could prevent disease recurrence after surgery. The safety signal prompted the board to recommend halting the study.

Genentech said the vaccine arm showed higher mortality in this specific patient population, while another phase 2 study of BNT122 combined with immunotherapy continues. The companies said they remain committed to evaluating the vaccine’s efficacy and safety.