Moderna and Merck said their personalized mRNA vaccine, given with pembrolizumab, lowered the risk of melanoma returning or death by 42% in a Phase 3 trial, but it is not yet known whether the combination helps patients live longer.
The INTerpath-001 study included 1,137 people with stage IIB to IV melanoma that had been completely removed by surgery. It compared the vaccine plus pembrolizumab with pembrolizumab and a placebo. The experimental vaccine, called intismeran autogene, is designed using mutations, or changes, found in each patient’s tumor to encourage an immune response against cancer cells.
After a median follow-up of 24.6 months, the combination also lowered the risk of cancer spreading to distant sites or death by 38%. At two years, 82.2% of patients receiving the combination were alive without a recurrence, compared with 70.0% of those in the pembrolizumab-only group. The findings were presented at the European Society for Medical Oncology meeting in Madrid.
It is too early to know whether the treatment helps patients live longer overall. The trial is continuing to track whether the treatment extends life. The companies reported no new safety concerns.
Merck and Moderna said they are working with regulators, but the vaccine remains under investigation.