Intismeran autogene with KEYTRUDA (cancer vaccine, with Merck)
Positive Phase 3 melanoma results in August 2026; detailed data and regulatory filing are still to come.
What it is
Intismeran autogene is an individualized mRNA cancer vaccine, developed with Merck, that is designed for each patient's tumor. In the Phase 3 INTerpath-001 trial, adding it to KEYTRUDA beat KEYTRUDA alone on recurrence-free survival and distant metastasis-free survival in 1,137 patients with melanoma. It is still investigational and has no approval in any market.
Why it matters to the stock. A positive Phase 3 result is the first for an individualized neoantigen therapy and for an mRNA cancer therapy. If approved, it could be a major new product for both companies, though the market is not yet sized and overall survival data are still pending.
News
Moderna names Juan Andres chief operating officer; Jerh Collins to retire
Moderna created a new chief operating officer role and appointed Juan Andres, a former Moderna technical operations executive who left in 2023, to fill it, effective October 5, 2026.
Intismeran autogene with KEYTRUDA beats Keytruda alone in Phase 3 melanoma trial
Merck and Moderna said the Phase 3 INTerpath-001 trial met its primary endpoint of recurrence-free survival and its key secondary endpoint of distant metastasis-free survival, with the combination improving both over KEYTRUDA alone in patients with completely resected melanoma.
Five-year Phase 2b melanoma data: intismeran plus KEYTRUDA cuts recurrence risk 49%
Moderna and Merck presented five-year Phase 2b data for intismeran autogene plus KEYTRUDA at ASCO, showing a 49% lower risk of recurrence or death than KEYTRUDA alone in 157 patients with high-risk melanoma.