Phase‑3 trial shows personalized mRNA vaccine cuts melanoma recurrence risk by 42% when added to Keytruda
+1 new source since this summary was written
Moderna and Merck reported that their individualized mRNA vaccine intismeran autogene, given with pembrolizumab (Keytruda), reduced the risk of melanoma recurrence or death by 42% versus pembrolizumab alone in the INTerpath‑001 Phase 3 study of 1,137 high‑risk patients. The 24‑month recurrence‑free survival was 82.2% with the combination versus 70.0% with pembrolizumab, and distant‑metastasis‑free survival was 88.5% versus 80.2%. The data were presented at the 2026 ESMO Congress and have been accepted for publication in The New England Journal of Medicine.
Why it matters
The company disclosed that the trial met its primary and key secondary endpoints, which may accelerate regulatory discussions for the vaccine (the company said the results are under regulatory review) (19). Analysts noted that despite the positive efficacy, the premature data leak triggered a sell‑off, with Moderna shares falling about 25% and wiping roughly $24 bn from market value (1).
Key facts
- 1The INTerpath‑001 trial enrolled 1,137 adults with resected stage IIB‑IV cutaneous melanoma. emjreviews.com
- 2Patients were randomized 2:1 to intismeran autogene plus pembrolizumab (n = 757) or placebo plus pembrolizumab (n = 380). emjreviews.com
- 3At a median follow‑up of 24.6 months, the hazard ratio for recurrence or death was 0.58, a 42% risk reduction (95% CI 0.45‑0.75). emjreviews.com
- 4The 24‑month recurrence‑free survival rate was 82.2% with the combination versus 70.0% with pembrolizumab alone. emjreviews.com
- 5The 24‑month distant‑metastasis‑free survival rate was 88.5% versus 80.2% respectively. emjreviews.com
- 6Grade 3 or higher adverse events occurred in 23.6% of combination patients and 20.3% of pembrolizumab‑only patients. onclive.com
Summary written by AlphAI AI Desk from 20 of 24 sources. Not investment advice. Figures are as stated by the linked sources.