Personalized mRNA vaccine intismeran plus pembrolizumab cuts melanoma recurrence risk by 42%

A Phase III INTerpath‑001 trial of intismeran autogene combined with pembrolizumab in resected high‑risk melanoma showed a 42% relative reduction in recurrence or death. The study enrolled 1,137 patients, randomised 2:1 to receive the vaccine (757) or placebo (380) alongside pembrolizumab. At a median follow‑up of 24.6 months, the 24‑month recurrence‑free survival was 82.2% versus 70.0% and the hazard ratio for recurrence or death was 0.58. The data were leaked two days before the scheduled ESMO presentation, triggering sharp sell‑offs in the stocks of the therapy’s developers.

The premature data leak caused Moderna shares to fall about 25%, wiping roughly $24 bn from market value, while Merck shares dropped nearly 1%. The strong efficacy signals could drive future revenue growth and regulatory engagement for both companies.

  • 1The trial enrolled 1,137 adults with resected stage IIB‑IV cutaneous melanoma.
  • 2Patients were randomised 2:1, with 757 receiving intismeran plus pembrolizumab and 380 receiving placebo plus pembrolizumab.
  • 3At a data cut‑off of 30 June 2026, median follow‑up was 24.6 months.
  • 4The hazard ratio for recurrence or death was 0.58, a 42% relative risk reduction.
  • 524‑month recurrence‑free survival was estimated at 82.2% with the combination versus 70.0% with pembrolizumab alone.
  • 6Moderna shares fell approximately 25% after the leak, erasing about $24 bn of market value.

Sources