Moderna and Merck Report Success in Melanoma Vaccine Trial

Merck and Moderna announced positive results from the Phase 3 INTerpath-001 trial, which evaluated the personalized mRNA cancer vaccine intismeran (mRNA-4157/V940) in combination with Keytruda (pembrolizumab). The trial involved patients with completely resected stage IIB-IV melanoma and successfully met its primary endpoint of recurrence-free survival (RFS). It also met a key secondary endpoint of distant metastasis-free survival (DMFS).

The INTerpath-001 trial is the first Phase 3 study to demonstrate that an individualized neoantigen therapy can offer clinically meaningful improvements over the current standard treatment of Keytruda alone. Intismeran is created using the unique mutations found within a patient's own tumor, designed to train the immune system to recognize and attack cancer cells.

During the trial, the combination of intismeran and Keytruda showed statistically significant improvements in both RFS and DMFS compared to patients receiving only Keytruda. The safety profiles for both drugs were consistent with findings from previous studies, and no new safety concerns were identified. The study is ongoing and will continue to track additional outcomes, including overall survival (OS).

Merck and Moderna plan to share the trial data at upcoming international medical meetings and will work with regulatory authorities to discuss potential approvals.