Moderna advances cancer vaccine push after melanoma trial

Moderna President Stephen Hoge announced on 14 September 2026 that positive Phase III trial results for its investigational personalized cancer vaccine, intismeran, in adjuvant melanoma support expanding the T-cell priming approach into other tumor types. Speaking at a Morgan Stanley event, Hoge stated that the trial was the first to show a statistically significant and clinically meaningful benefit over Merck's KEYTRUDA in adjuvant melanoma.

Moderna and its partner Merck are currently conducting nine clinical trials for intismeran across more than 40 countries, including three randomized Phase III trials in lung cancer. Fully enrolled event-driven Phase II trials in renal cell carcinoma and muscle-invasive bladder cancer each include roughly 300 patients randomized one-to-one against standard care using KEYTRUDA as a comparator, alongside a Phase II monotherapy study in non-muscle-invasive bladder cancer.

The company has treated about 3,000 patients with intismeran, including an estimated 1,500 to 2,000 over the past 18 months. Moderna built an automated manufacturing facility in Marlborough, where the first of seven suites provides enough capacity for an initial commercial launch, while additional capacity requires about 12 months of lead time.

Hoge reaffirmed Moderna's goal to reach break-even in 2028, supported by its infectious-disease business. The company currently guides for up to 10% top-line growth this year, backed by five product approvals across COVID-19, influenza, respiratory syncytial virus, a flu/COVID combination shot, and the next-generation mNEXSPIKE vaccine.