BioNTech ends colorectal Phase 2 of autogene cevumeran after a survival imbalance; pancreatic trial continues

BioNTech/Autogene cevumeran (BNT122)

BioNTech terminated the BNT122-01 trial, which gave autogene cevumeran alone after surgery to colorectal cancer patients with tumour DNA still detectable in their blood, compared with watchful waiting. The independent safety board saw a numerical imbalance in overall survival between the arms and judged that continuing would not change the efficacy result. The trial had already crossed its futility boundary in October 2025, when the data were too immature to conclude.

• Planned for about 327 patients with high-risk stage II or stage III colorectal cancer; main goal was disease-free survival.
• No new safety signals were found.
• Decision taken with partner Genentech; the pancreatic IMCODE003 trial, which adds a checkpoint drug and chemotherapy, continues as planned.