An individualized mRNA-based cancer therapy has delivered its first positive Phase 3 readout, potentially marking an important step toward more personalized immunotherapy for melanoma. Merck and Moderna announced positive topline results from the Phase 3 INTerpath-001 trial evaluating intismeran autogene (intismeran, V940 or mRNA-4157) in combination with pembrolizumab (Keytruda) as adjuvant treatment for patients with completely resected stage IIB-IV cutaneous melanoma. The combination met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS), demonstrating statistically significant and clinically meaningful improvements compared with pembrolizumab alone.

The findings represent the first positive Phase 3 readout for an individualized neoantigen therapy and an mRNA-based cancer therapy. They also mark the first…