Merck and Moderna's mRNA Therapy Shows Positive Results in Melanoma Trial

Merck and Moderna announced positive topline results from their Phase 3 INTerpath-001 trial evaluating adjuvant treatment with intismeran autogene, a novel mRNA-based individualized neoantigen therapy (INT), in combination with KEYTRUDA for patients with completely resected stage IIB-IV melanoma.

The trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). This represents the first positive Phase 3 readout for an individualized neoantigen therapy (INT) and for an mRNA-based cancer therapy, as well as the first Phase 3 study to demonstrate a clinically meaningful improvement over KEYTRUDA alone in the adjuvant setting.

The safety profiles of intismeran and KEYTRUDA were consistent with those observed in previously reported studies for the combination, with no new safety signals observed.