Merck and Moderna's Individualised Melanoma Vaccine Clears Phase 3 Hurdle

A personalised mRNA melanoma vaccine developed by Merck and Moderna has shown promising results in its first Phase 3 trial. The therapy, called intismeran autogene (V940 or mRNA-4157), is built from a sample of each patient's own resected tumour and trains the immune system to recognise and attack cells carrying specific mutations.

The trial, known as INTerpath-001, enrolled 1,137 patients with completely resected stage IIB-IV cutaneous melanoma who had not previously received systemic treatment. Patients were randomised two to one, receiving either intismeran autogene alongside Merck's existing immunotherapy pembrolizumab (Keytruda), or pembrolizumab alone.

The trial met its primary endpoint, recurrence-free survival, meaning patients on the combination were significantly less likely to have their melanoma return within the study's follow-up window than patients on pembrolizumab alone. It also met a key secondary endpoint, distant metastasis-free survival, tracking whether the cancer spread to distant organs.

Merck and Moderna have not yet published the hazard ratios, confidence intervals, or the actual difference in recurrence rates between the two groups; that level of detail is being held for presentation at an upcoming international medical meeting, with regulatory filings to follow.