Malaga leads trial of Spain's first personalised melanoma vaccine

The study was conducted at the hospital with the participation of the Ibima Bionand platform.

Six Spanish hospitals have taken part in this study, sponsored by pharmaceutical companies Moderna and MSD. Of the 71 patients initially assessed for possible inclusion, 24 were from the Malaga hospital, accounting for around 34 per cent of the national total and the highest figure among the participating centres.

Ultimately, 15 patients from the hospital were able to join the trial.

The sponsoring companies have announced positive results from this final phase of the study, which compares standard treatment with immunotherapy against a new strategy that adds a messenger RNA vaccine, specifically designed for each patient, to that same treatment.

The trial has met its primary objectives with statistically significant and clinically relevant results in reducing the risk of relapse and the development of distant metastases.

One of the key innovations of this strategy is that the vaccine is tailor-made for each individual patient. It uses messenger RNA technology, as in some of the Covid-19 vaccines, although with one key difference: in this case, there is no single vaccine for all patients. Instead, each vaccine is designed based on the characteristics of the patient's own tumour.

To produce the vaccine, a sample of the melanoma must first be obtained through surgery. The tumour tissue is compared with healthy tissue from the same patient to identify the characteristics that distinguish the cancer cells. Based on this analysis, up to 34 tumour-specific proteins or neoantigens with the greatest potential to be recognised by the immune system are selected and incorporated into the messenger RNA vaccine, with the aim of promoting a more targeted immune response against the tumour.

The vaccine is administered alongside immunotherapy, which is currently the standard treatment for these patients. The trial aims to determine whether adding this personalised vaccine to standard treatment improves outcomes and reduces the risk of the disease returning.

It is therefore not a preventive vaccine, but rather a therapeutic strategy aimed at people who have already been diagnosed with melanoma, have undergone surgery and are at high risk of relapse.

Medical oncologist Miguel Berciano says that "these results consolidate a very promising line of research and represent a significant step towards an increasingly personalised approach to oncology, in which we can use the tumour's own information to design therapeutic strategies specific to each patient".

Berciano says that "the value of this approach lies in combining the immunotherapy we already routinely use with a vaccine designed to help the immune system recognise the specific characteristics of the tumour".

The development of a trial of this nature requires close multidisciplinary coordination. Alongside the medical oncology department, work experts from the surgical departments involved in obtaining tumour samples, as well as the dermatology and pathology departments.

Co-ordination between these teams is essential, from the surgical procedure and collection of tissue right through to its proper processing and analysis, in order to begin the process of producing the personalised vaccine.

It is precisely the complexity of this procedure that explains why not all patients initially assessed are ultimately able to receive the vaccine. It is necessary to have a suitable tumour sample, meet the criteria set out in the protocol and successfully complete the various stages of analysis and production of a treatment that is manufactured specifically for each individual.

Review public health, medical care and clinical news