Melanoma: The mRNA Vaccine That "Teaches" the Immune System to Destroy Cancer

“With the mRNA vaccine, we are entering a new era in oncology: we are no longer administering a generic treatment, but rather reprogramming the immune system to hunt down and destroy cancer based on each patient’s unique profile.” This is the enthusiastic statement from Paolo Ascierto, full professor of Oncology at the University of Naples Federico II, coordinator of the study for Italy, and member of the international steering committee— the first scientist to have administered this therapeutic vaccine in Italy at the Pascale Cancer Institute in Naples. Ascierto highlights the historic significance of the Phase 3 results obtained from the combination of mRNA technology and immunotherapy.

“Inthe interimanalysis, we recorded extraordinary results for both recurrence-free survival and distant metastasis-free survival. A true gold nugget: preventing the tumor from spreading to other organs is a crucial milestone, extremely close to the most coveted goal of all—Overall Survival, the patient’s overall survival.” He clarifies:“We’re not talking about a preventive vaccine for healthy people, but rather a post-surgical therapeutic treatment. By sequencing the tumor tissue of each individual patient, artificial intelligence selects—with surgical precision—the 34 neoantigens most capable of triggering an immune response. In this way, we create a ‘tailored’ mRNA drug that, when administered alongside immunotherapy, instructs our immune system to eliminate any residual tumor cells.”

The trial, in fact, involves high-risk patients who have already undergone surgical removal of their melanoma. “We’re talking about stages 2b, 2c, 3, and even stage IV patients whose lesions have been completely removed. Intervening when the visible tumor is no longer present means thoroughly clearing out any invisible traces remaining in the bloodstream,” adds Professor Ascierto, continuing, “It’s an exceptional result that enhances immunotherapy and will become the new standard of care. But the real strength lies in the fact that this mechanism can be applied to other cancers, such as lung, kidney, bladder, and pancreatic cancer. “The future challenge will be to optimize the production process —which currently takes about six weeks, including the biopsy, AI algorithms, and mRNA synthesis—to reduce time and costs, ensuring access and sustainability for healthcare systems.”

Italian scientific research played a leading role in this global milestone. “Italy was the country that enrolled the highest number of patients in the entire study ,” emphasizes Paolo Ascierto. “ In addition to my work on the steering committee, I am proud of the excellence demonstrated by our country.”

Commenting on the announcement by Moderna and Merck regarding the Phase 3 results of the experimental melanoma vaccine, the professor added that in Italy, the pool of eligible patients—once FDA, EMA, and AIFA, could be around 3,000 people, and he explained that this is only the beginning of a broader revolution: in fact, several clinical trials of mRNA anti-tumor vaccines are currently underway for other cancers, such as lung and kidney cancer, while a particularly interesting field of research is opening up regarding pancreatic cancer. The complete data, he specified, will be presented shortly at a scientific conference.