Moderna and Merck reported five-year follow-up data from their phase IIb trial of personalized mRNA-1893 autogene therapy combined with pembrolizumab in high-risk melanoma patients. The combination therapy achieved a 49% reduction in the risk of recurrence or death compared to pembrolizumab alone (hazard ratio 0.51; 95% CI: 0.35–0.74). The study enrolled 312 stage III and resected stage IV patients across 45 centers in North America and Europe. Five-year recurrence-free survival was 68% in the combination arm versus 46% in the control arm. Safety profiles remained consistent with known adverse events of checkpoint inhibition, with grade 3–4 immune-related events occurring in 18% of combination-treated patients versus 15% in the monotherapy group.

In a Bloomberg Television interview at the World Economic Forum, CEO Stéphane Bancel stated that Moderna will not initiate any new late-stage vaccine trials in the near term due to intensified scrutiny from U.S. health authorities. The decision follows sharp questions from regulators and lawmakers over vaccine efficacy benchmarks and post-authorization safety monitoring. Moderna’s pipeline still includes four ongoing Phase III vaccine studies—two for seasonal influenza, one for RSV and one for cytomegalovirus—but no additional late-stage trials will be launched until clarity emerges on regulatory requirements. This strategic shift reallocates an estimated $200 million in R&D budget toward oncology and rare disease programs in 2026.