全球首个!癌症定制疫苗来了
TL;DR - Moderna and Merck’s personalized mRNA cancer vaccine, intismeran autogene, achieved positive interim results in a Phase III melanoma trial—the first reported confirmatory Phase III success for a personalized neoantigen vaccine. Combined with pembrolizumab, it significantly improved recurrence-free and distant-metastasis-free survival versus pembrolizumab alone, though detailed efficacy and overall-survival data remain pending.
- The trial enrolled 1,137 patients with resected stage IIb–IV melanoma and compared one year of vaccine-plus-pembrolizumab treatment with pembrolizumab alone.
- The vaccine uses tumor sequencing, multi-omics, and AI-based screening to select up to 34 patient-specific neoantigens for an individualized mRNA formulation.
- Earlier Phase IIb follow-up reported a 49% reduction in recurrence or death risk and a 59% reduction in distant-metastasis risk.
- No new safety signals were reported, but high individualized manufacturing costs, uncertain efficacy in less immunogenic cancers, and limited evidence in advanced unresectable disease remain challenges.