Merck and Moderna's mRNA Cancer Vaccine Combo Shows Positive Phase 3 Results

Merck and Moderna announced positive results from their Phase 3 INTerpath-001 trial evaluating intismeran autogene (also known as V940 or mRNA-4157), an individualized mRNA-based neoantigen therapy, in combination with Merck's KEYTRUDA (pembrolizumab) for patients with completely resected stage IIB-IV melanoma.

The trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival. This marks the first positive Phase 3 readout for an individualized neoantigen therapy and for an mRNA-based cancer treatment.

The combination therapy showed statistically significant improvements in both endpoints among patients with resected stage IIB, IIC, III or IV cutaneous melanoma who had not previously received systemic therapy. Safety results were consistent with prior studies of the combination, with no new safety signals identified.