Moderna's Cancer Vaccine Achieves Historic Win in Phase 3 Trial

Moderna's cancer vaccine has achieved a significant milestone after passing its phase 3 trial. The mRNA therapy, developed in partnership with Merck, met both primary endpoints in a melanoma study, marking the first positive phase 3 result for an mRNA cancer vaccine. The trial, INTerpath-001, enrolled 1,137 patients with high-risk stage IIB through IV melanoma and found that the combination of intismeran autogene paired with Keytruda improved recurrence-free survival and distant metastasis-free survival compared to Keytruda alone.

The FDA has not yet disclosed the magnitude of the benefit or overall survival data. This achievement provides Moderna with a potential path beyond its COVID-19 vaccine franchise. The company's newly approved flu shot, mFlusiva, was also highlighted in this week's PharmaVoice newsletter.

Ultragenyx has received its first gene therapy approval for Genglycos, a treatment for glycogen storage disease type Ia (GSDIa). The FDA granted accelerated approval to the one-time AAV8 gene therapy for patients 8 years and older. However, Ultragenyx must still confirm the therapy's clinical benefit.