Moderna and Merck announced median five-year follow-up results from their Phase IIb KEYNOTE-942/mRNA-4157-P201 study in high-risk stage III/IV melanoma patients who had undergone complete surgical resection. The combination of Moderna’s personalized mRNA-based therapy, intismeran autogene, with Merck’s Keytruda demonstrated a 49% reduction in the risk of recurrence or death compared to Keytruda alone. This benefit matches the 49% risk reduction observed at the three-year mark, underscoring the durability of the immune response. The individualized vaccine encodes up to 34 neoantigens tailored to each patient’s tumor mutational profile. Safety data remained consistent with earlier reports, with no new adverse signals reported over the extended follow-up.

With roughly 112,000 new melanoma cases projected in the U.S. for 2026, analysts estimate the personalized vaccine could command a price point comparable to Keytruda, potentially exceeding $200,000 per treatment course. Morningstar projects multi-billion-dollar peak sales in melanoma alone if the Phase III trial replicates these results. Moderna and Merck plan to present comprehensive primary and secondary endpoint data at an upcoming oncology conference. Concurrent trials are evaluating intismeran autogene in kidney, lung and bladder cancers, reflecting the platform’s broader applicability.

Moderna CEO Stephane Bancel told Bloomberg TV that the company will not initiate any new late-stage vaccine trials this year, citing increased scrutiny of immunizations by U.S. health officials. He made the comments at the World Economic Forum in Davos. Moderna will reallocate resources toward oncology and other mRNA-based therapeutics, while continuing ongoing early-stage vaccine research. This strategic refocus could free up an estimated $500 million in R&D budget for cancer and rare disease programs in 2026.