Overview
- Moderna and Merck released full INTerpath‑001 phase 3 results Thursday showing intismeran given with pembrolizumab reduced the risk of melanoma recurrence or death by 42% at about two years versus pembrolizumab alone.
- In absolute terms the trial of roughly 1,137 surgically resected high‑risk melanoma patients found 82% of vaccinated patients were recurrence‑free at two years versus 70% with pembrolizumab and placebo.
- A key secondary endpoint showed a 38% lower risk of distant metastasis or death with the vaccine combination, and sensitivity analyses suggest the benefit emerges after the six‑month dosing period.
- Reported side effects were generally mild and similar to prior mRNA vaccines, investigators found no new safety signals, and median follow‑up is about 24–25 months with ongoing monitoring for overall survival.
- Companies say they are engaging regulators and preparing filings, but real‑world hurdles remain including bespoke manufacturing, the fact ~17% of screened patients lacked enough tumor tissue, pricing and health‑system adoption.