the first dose in Italy

It was administered at the Pascale Tumor Institute in Naples the first anti-melanoma vaccine in Italy, based on the experience of mRNA research, developed during the Covid-19 pandemic. It was received by Alfredo De Rienzi, 71 years old, a general practitioner from Carovilli, in the province of Isernia, the first patient to start the phase III trial of Moderna’s cancer drug in our country.

The drug

The vaccine has reached the final stage of human testing before it can receive approval from international drug agencies. The objective of the research it is not to prevent disease, but to help and support the immune system of patients to recognize and attack the tumor more effectively.

“I accepted immediately – said De Renzis – it seemed right to me for my role as a doctor to make a contribution to research. I have never been afraid.”

The 71-year-old thus hopes to make his contribution to the experimentation which could provide him with a weapon that will help him defeat melanoma.

The conditional in this case is necessary because, Since it was a ‘double-blind’ test, De Rienzis may have received a dose of placebo: “According to protocol, in fact, neither the patient nor the oncologist knows what was injected into him. We will know at the end of the trial” explained Paolo Ascierto, director of the department of melanoma oncology, oncological immunotherapy and innovative therapies of the National Cancer Institute IRCCS Pascale Foundation of Naples, which has been treating the 71-year-old since September last year.

Even if, specifies Ascierto, “it will take a few years before having the results of this last phase of the clinical study, phase III”, De Rienzis does not lose heart and says he is “serene”: “I am not afraid, I trust the science and I trust the colleagues who help me they are following,” he said.

Hope is supported by data from the phase II study of the mRNA vaccine, released last December by Moderna and MSD, which, as reported by Republicthey showed a 44% reduction in the risk of relapse in melanoma patients treated in combination with monoclonal antibodies.

“Our hope is to be able to give a new and more effective therapeutic option to as many patients as possible” stated Ascierto (here we had reported the boom in tumors among young people in the last 20 years).

“The vaccine, produced by Moderna it is based on the same technology adopted for those against Covid – he explained – that is, using synthetic mRNAs designed to ‘instruct’ the immune system to recognize specific proteins, called ‘neoantigens’, which are the expression of genetic mutations that have occurred in diseased cells”.

The patient

A general practitioner, married with two children, De Rienzis discovered two years ago that a skin growth was actually a melanoma (here we reported the EU healthcare expenditure for the treatment of tumors each year).

After the first therapies in Isernia he then arrived in Naples, to be treated in the Ircss Pascale department led by Paolo Ascierto.

In September 2023 the appearance of inguinal lymph node metastases and the operation in November. On December 15, the 71-year-old began treatment with Pembrolizumab as part of the V904 study, when, almost simultaneously with the start of immunotherapy, the proposal to join Phase III of Moderna’s first mRNA vaccine against melanoma (here we talked about the new drug against lung cancer for a limited category of patients).