Melanoma vaccine cuts recurrence risk
Moderna and Merck announced positive Phase 3 results for a personalized mRNA cancer vaccine. The therapy, intismeran autogene (mRNA-4157), combined with Keytruda, substantially reduced melanoma recurrence and spread. The Phase 3 INTerpath-001 trial involved over one thousand patients with high-risk resected melanoma, receiving either the combination or Keytruda alone. The combination achieved statistically significant improvements in recurrence-free survival, the primary goal. It also improved distant metastasis-free survival, reducing cancer spread. This marks a pivotal moment, being the first positive Phase 3 outcome for an individualized neoantigen and mRNA cancer treatment, and the first to show improvement over Keytruda alone in adjuvant resected melanoma. Intismeran autogene is a personalized vaccine, designed for each patient by analyzing their tumor to identify its unique genetic 'fingerprint'. It uses mRNA technology to instruct the immune system to attack specific cancer neoantigens, training the body’s defenses to target tumor cells. Earlier Phase 2b data showed the combination reduced the risk of melanoma recurrence or death by 49 percent, and distant metastasis or death by 59 percent, compared to Keytruda alone. No new safety concerns arose in the Phase 3 trial, with the safety profile consistent with previous observations. The firms will present detailed trial data at an upcoming medical meeting and engage with regulatory authorities for approval.
