Seis hospitales españoles participaron en el ensayo de la vacuna contra el melanoma

Spain saw six hospitals involved in the trial of the new mRNA vaccine against melanoma, with Barcelona, Madrid, Málaga, and Valencia serving as the primary locations. This phase 3 trial evaluated the first personalized mRNA vaccine against melanoma, as reported in ClinicalTrials.gov. Globally, 35 hospitals in 26 countries participated in the study.

On Wednesday, Moderna and MSD (Merck outside US and Canada) announced that the trial had reached its primary goals. The combination of the vaccine, dubbed intismeran autogene, and the immunotherapy pembrolizumab showed statistically significant results in both recurrence-free survival and distant metastasis-free survival. However, the pharmaceutical companies have not disclosed the exact increase in survival or the reduction in recurrence risk.

This milestone is historic as it marks the first successful phase 3 trial for a vaccine of this type and the first time an RNA messenger-based oncology treatment has reached this stage. The Regional University Hospital of Málaga contributed the most patients to the study, with 24 out of the 71 initially evaluated in Spain. Oncologist Miguel Berciano, who coordinated the study in the Andalusian hospital, noted that these results point towards "more personalized oncology" where information specific to each tumor allows for tailored treatments.

The trial required close coordination between oncology, surgery, dermatology, and pathology services due to the need for adequate tumor samples and individualized manufacturing for each patient. In a previous phase 2 trial, the vaccine showed a 49% reduction in the risk of recurrence or death and a 59% reduction in metastasis risk.

However, only 157 patients participated. The new trial involved 1,137 patients with melanoma (the most dangerous form of skin cancer) from the 35 hospitals. These patients had already undergone surgical removal of the tumor but were at high risk of recurrence. The patients were divided into two groups, with one-third receiving pembrolizumab alone and the remaining two-thirds receiving the combination of pembrolizumab and the personalized vaccine developed by MSD and Moderna.

Both companies are already running eight more trials with this personalized vaccine technology for other cancers, including lung, bladder, and kidney. Following Wednesday's announcement, MSD and Moderna will present the complete data at an international medical conference and begin discussions with regulatory authorities to seek approval for the treatment, potentially bringing the vaccine into the medical arsenal against this tumor.

This vaccine works differently than those against viruses, which are mass-produced and immunize a large population to prevent an illness. Instead, it is personalized for an individual's cancer after its appearance.