Moderna and Merck reported five-year follow-up results from their Phase 2 study of intismeran autogene plus Merck’s PD-1 inhibitor in high-risk stage III/IV melanoma patients. The combination therapy reduced the risk of recurrence or death by 49% compared with the PD-1 inhibitor alone. This sustained benefit, consistent with earlier three-year findings, represents the first demonstration of durable added benefit in the adjuvant melanoma setting and underscores the potential of personalised mRNA neoantigen vaccines.

Building on the melanoma success, Moderna and Merck have multiple trials in lung, kidney and bladder cancer. A fully enrolled Phase 3 melanoma adjuvant study (INTerpath-001) and two Phase 3 trials in resected non-small cell lung cancer are underway. Phase 2 studies in renal cell carcinoma and various bladder cancer settings are either enrolled or actively recruiting. This portfolio positions Moderna to pivot from its core respiratory vaccine revenues toward an oncology franchise with potential peak sales in the low-single-digit billions, according to industry analysts.

With its respiratory vaccine business facing stagnating demand, the melanoma data is viewed by many investors as a critical turning point. Analysts at Morningstar and William Blair have highlighted the durability of the immune response and the large addressable melanoma market—an estimated 112,000 U.S. cases in 2026—as key positives. However, consensus forecasts for peak vaccine pricing (around $200,000 per course) and commercial uptake remain cautious, and average analyst price targets sit below current trading levels, reflecting uncertainty ahead of pivotal Phase 3 readouts.