Moderna-Merck personalized melanoma vaccine cuts recurrence risk 42% in Phase 3 trial

Merck and Moderna released detailed results from the 1,137-patient Phase 3 INTerpath-001 trial in people whose stage IIB-IV melanoma had been surgically removed. After a median 24.6 months, adding the individualized mRNA therapy intismeran autogene to Keytruda reduced the risk of recurrence or death by 42% and the risk of distant metastasis or death by 38%, the companies said. Two-year recurrence-free survival was 82.2% versus 70.0%. Overall survival data are not yet mature.

The data, set for the ESMO congress in Madrid, came out early after an embargo breach. Moderna shares closed down 15.6% on Thursday as some figures came in below earlier-stage results, Clinical Trials Arena reported. The companies said they are talking with regulators.

Why it matters: The trial is a major late-stage test of tailor-made mRNA cancer vaccines, each built from a patient's own tumor. The results have been accepted for publication in the New England Journal of Medicine.