Overview
- A five‑year update of a Phase‑IIb study found that adding the personalized mRNA vaccine Intismeran to standard pembrolizumab reduced the risk of melanoma recurrence by about 49% and cut distant metastases by about 59% compared with immunotherapy alone.
- The trial enrolled roughly 157 patients with high‑risk melanoma, with 107 receiving the vaccine plus pembrolizumab and 50 receiving pembrolizumab alone, and it was not blinded which patients got the vaccine.
- The study did not show a clear overall survival advantage because both groups recorded seven deaths, a number too small to draw firm conclusions about mortality benefit.
- Intismeran is made for each patient by sequencing tumor tissue to select about 20–34 neoantigens and is given alongside a year of checkpoint‑inhibitor infusions; an international Phase‑3 trial of about 1,000 patients is under way to test whether the Phase‑IIb results hold.
- Widespread use would face steep hurdles from complex bespoke manufacturing, tight logistics and high projected costs—estimates reported range from over €100,000 to figures discussed near €300,000 per patient—which could limit access even if Phase‑3 confirms benefit.