BNT122 Pancreatic Cancer mRNA Vaccine: ~50% Alive and Disease-Free at 6 Years in Phase 1

Dr. Vinod Balachandran of Memorial Sloan Kettering Cancer Center presented landmark 6-year follow-up data from the Phase 1 trial of BNT122 (autogene cevumeran), a personalized mRNA neoantigen vaccine for pancreatic ductal adenocarcinoma (PDAC), at the AACR Annual Meeting in San Diego. Key findings: nearly half (8 of 16) of trial participants are alive and cancer-free up to six years post-treatment — a historically extraordinary outcome given pancreatic cancer's typical 5-year survival rate of under 12%. Eight of 16 patients demonstrated durable immunological responses; 7 of those 8 remain alive. Tumor-specific CD8+ killer T-cells induced by the vaccine are estimated to have an average lifespan of 7.7 years, demonstrating long-lasting immune memory. The vaccine was administered post-surgery and encodes up to 20 personalized neoantigens identified via tumor sequencing, manufactured with a 6–8 week turnaround. A Phase 2 multicenter randomized trial (NCT05968326), sponsored by Genentech in collaboration with BioNTech/Pfizer, is currently enrolling at sites in the US and Europe.