Moderna and MSD report Phase 3 success for mRNA melanoma vaccine

Moderna and MSD have announced positive results from a pivotal Phase 3 clinical trial for intismeran autogene, a personalized mRNA cancer vaccine. The trial, known as INTerpath-001, evaluated the vaccine in combination with the immunotherapy pembrolizumab for patients with stage IIB to IV cutaneous melanoma following complete surgical removal of the tumor.

The combination therapy demonstrated statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival compared to pembrolizumab monotherapy. This marks the first time an individualized neoantigen therapy utilizing mRNA technology has achieved positive results in a large-scale, randomized Phase 3 trial.

Intismeran autogene is manufactured specifically for each patient by mapping the unique mutational signature of their tumor through genomic sequencing. While the companies have confirmed the positive outcome, detailed numerical datasets and hazard ratios are expected to be presented at an upcoming international medical congress.