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Adding a personalized mRNA-based cancer vaccine to immunotherapy after surgery for high-risk melanoma reduced the risk of recurrence or death by 42%, according to results from the phase 3 INTerpath-001 trial presented at the ESMO Congress 2026. The vaccine, intismeran autogene, was given alongside pembrolizumab and compared with pembrolizumab alone.
Anti-PD-1 immunotherapy, such as pembrolizumab, is a standard treatment after surgery for high-risk melanoma, yet many patients still experience recurrence. Previous phase 3 trials adding a second checkpoint inhibitor failed to improve on anti-PD-1 treatment alone. Intismeran takes a different approach, with each patient's tumor being sequenced to identify neoantigens—abnormal proteins specific to their cancer. Up to 34 neoantigens are encoded in mRNA to help the immune system recognize and attack any remaining cancer cells.
The trial randomly assigned 1,137 adults who had undergone surgery for stage IIB–IV cutaneous melanoma to pembrolizumab plus either intismeran (757 patients) or placebo (380 patients).
001). 0% receiving pembrolizumab alone. 2% alive without distant metastasis at two years. Benefits were similar across lower- and higher-risk disease groups.
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