Merck and Moderna Announce Phase 3 INTerpath-001 Trial of Intismeran Autogene Plus KEYTRUDA Met Endpoints of Recurrence‑Free Survival (RFS) and Distant Metastasis‑Free Survival (DMFS) in Patients With Completely Resected Stage IIB‑IV Melanoma
The Phase 3 INTerpath‑001 trial demonstrates that adjuvant treatment with the individualized neoantigen mRNA therapy intismeran in combination with pembrolizumab (KEYTRUDA) leads to statistically significant and clinically meaningful improvements in recurrence‑free survival (RFS) and distant metastasis‑free survival (DMFS) compared with KEYTRUDA alone in patients with completely resected stage IIB‑IV cutaneous melanoma.
Merck and Moderna announced positive topline results from the Phase 3 INTerpath‑001 trial, showing that the individualized neoantigen mRNA therapy intismeran combined with pembrolizumab improved recurrence‑free and distant metastasis‑free survival compared with pembrolizumab alone in patients with completely resected stage IIB‑IV cutaneous melanoma.
This is the first Phase 3 readout for an individualized neoantigen therapy and a first mRNA‑based cancer therapy to demonstrate a clinically meaningful benefit over standard adjuvant immunotherapy, potentially establishing a new treatment paradigm for high‑risk melanoma patients.
Evidence level: Korai humán adat. Kis vagy feltáró emberi adat.
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