A personalized anti-cancer vaccine, developed by the American company Moderna together with the pharmaceutical group Merck, has demonstrated significant benefits in an international phase three clinical trial.
Administered alongside the immunotherapy Keytruda, the vaccine reduced the risk of cancer recurrence or death by 42% in patients with high-risk melanoma, according to the results of the INTerpath-001 study.
The research, which included 1,137 patients, marks an important step for personalized immunotherapy.
The results were made public on Thursday, ahead of the scheduled presentation at the European Society for Medical Oncology (ESMO) congress, held in Madrid, writes Le Monde.
How the personalized vaccine works
The treatment, called intismeran autogene, also known as V940 or mRNA-4157, uses messenger RNA technology to help the immune system recognize and attack cancer cells.
Unlike preventive vaccines, this one is designed for patients who have already been diagnosed with cancer and have undergone surgery to remove the tumor.
The vaccine is tailored to the genetic profile of each patient's tumor.
Based on mutations identified in the cancer cells, specific targets called neoantigens are selected to help the immune system distinguish tumor cells from healthy ones. The goal is to identify and eliminate any remaining cancer cells in the body after surgery, thus reducing the risk of recurrence.
According to information published by Moderna and Merck, the vaccine is administered in combination with pembrolizumab, marketed under the name Keytruda, a drug that helps the immune system fight cancer.
Study results: 82% of patients did not have a recurrence after two years
The study included patients with advanced but still operable melanoma, at high risk of recurrence or metastasis. Participants received either the personalized vaccine combined with Keytruda, or Keytruda along with a placebo.
After two years, 82.2% of patients who received the vaccine and immunotherapy were alive without disease recurrence, compared to about 70% in the group treated only with Keytruda.
Researchers calculated a 42% reduction in the risk of recurrence or death and a 38% reduction in the risk of metastasis. These percentages represent reductions in relative risk, not a 42% increase in the chance of cure.
The results were described by Fabrice André, research director at the Gustave-Roussy Institute in France, as a real clinical benefit. In statements cited by Le Monde, the specialist emphasized that this is the first time the efficacy of a personalized cancer vaccine has been demonstrated in a study of this type.
An important step, but the vaccine is not yet approved
The results are important because they represent a solid clinical demonstration of the potential of messenger RNA-based personalized therapies in the treatment of melanoma.
However, the vaccine is still experimental and not widely available.
Moderna and Merck are seeking the necessary approvals from regulatory authorities.
Safety and long-term efficacy must continue to be evaluated, and the results obtained in melanoma do not automatically demonstrate that the same approach will work for other types of cancer.
The two companies are already testing this technology in studies targeting other tumors. If the benefits are confirmed, personalized vaccines could become an important component of oncological treatments, alongside surgery, immunotherapy, and other therapies tailored to the characteristics of each patient.