Merck and Moderna Report Landmark Success in Personalized Melanoma Therapy Trial

Merck and Moderna have announced significant results from their Phase 3 INTerpath-001 trial for personalized mRNA-based cancer treatment. The therapy, called intismeran autogene (intismeran; V940 or mRNA-4157), demonstrated a statistically significant and clinically meaningful improvement in both recurrence-free survival and distant metastasis-free survival when added to KEYTRUDA compared with the immunotherapy alone.

The trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival, marking what the companies describe as the first positive Phase 3 readout for an individualized neoantigen therapy and an mRNA-based cancer therapy.

The results represent the first Phase 3 study to show a clinically meaningful improvement over KEYTRUDA alone in the adjuvant treatment of resected melanoma. The therapy was found to significantly reduce the risk of melanoma recurrence and distant metastasis in patients with completely resected stage IIB-IV melanoma.

Professor Georgina Long, the study's principal investigator, stated that 'Today's results represent a landmark moment for adjuvant melanoma treatment. This is the first Phase 3 study to show that intismeran, a treatment designed based on the unique mutational 'fingerprint' of a patient's own tumor, given in combination with pembrolizumab can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to KEYTRUDA alone.'