Moderna and Merck report first successful late-stage mRNA cancer vaccine trial

In a landmark trial involving more than 1,000 individuals with surgically removed localized melanoma, the Moderna-Merck mRNA vaccine intismeran autogene halted disease recurrence and metastasis, delivering the first successful late-stage outcome for a therapeutic cancer vaccine in over 100 years. The companies plan to present the findings at a major cancer meeting and submit the data to the US FDA, aiming for approval by 2027.

Their collaboration, begun in 2016 with Merck contributing $200 million upfront and an additional $250 million in 2022, leverages Moderna’s messenger RNA technology and Merck’s Keytruda checkpoint inhibitor to target dozens of patient-specific tumor mutations. Executives highlighted the urgency of translating the results into further trials for cancers with fewer mutations, such as lung and pancreatic cancers. Market analysts estimate the product could generate US$1 billion in sales by 2030 and up to US$3 billion by 2035. The success also offers Moderna a growth avenue beyond COVID-19 vaccines and positions Merck ahead of Keytruda’s upcoming patent expiration.