Melanoma, the first Italian patient receives the mRNA vaccine

Melanoma, the first Italian patient receives the mRNA vaccine

“I accepted immediately. It seemed right to me for my role as a doctor, to make a contribution to research, but also because I trust in this treatment.” There is so much courage and so much hope in the words of Alfredo De Renzis, 71 years old from Carovilli, a small town in the province of Isernia, and a patient suffering from melanoma. De Renzis is officially the first Italian patient to open the phase III trial of Moderna’s mRNA cancer vaccine, the last phase of testing before its approval. In reality he is the first patient ever who may have received the promising therapeutic vaccine in Italy, given that our country was excluded from phase I and II trials.

The first patient in Italy

The conditional is a must, because neither De Renzis nor his oncologist Paolo Ascierto, they actually know whether the one they have just inoculated is the vaccine or a placebo. “Being a ‘double-blind’ trial, this patient could have received a dose of placebo,” explains Ascierto, director of the department of melanoma oncology, oncology immunotherapy and innovative therapies at the National Cancer Institute IRCCS Fondazione Pascale in Naples. “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”, he specifies. However, De Renzis is the fiftieth patient in the world to take part in this last fundamental step in the testing of the Moderna vaccine.

“I’m calm”, admits the patient “one”, who has plenty of courage. A general practitioner, married with two children, two years ago he discovered that a melanoma was hiding behind a skin growth. After the initial treatment in Isernia he arrives in Naples, in the department of the Pascale Tumor Institute led by Ascierto. In September last year he had an appearance of inguinal lymph node metastases. Having undergone surgery in November, he begins treatment with the immunotherapy treatment pembrolizumab on December 15 as part of the V904 study. Almost simultaneously with the start of immunotherapy, he received the offer to join the phase III trial of Moderna’s first mRNA vaccine, the last step before the vaccine can be authorized by the regulatory authorities. “I’ve never been afraid,” he says. “I consider myself lucky because immunotherapy has not brought me any particular side effects,” he adds.

The technology used against Covid

But the type of immunotherapy he “maybe” received this morning is different from that of the past. “The vaccine, produced by Moderna – explains Ascierto – is based on the same technology adopted for those against Covid, that is, using synthetic mRNAs designed to ‘instruct the immune system to recognize specific proteins, called ‘neoantigens’, which are the expression of genetic mutations occurred in the diseased cells. Its purpose is not to prevent the disease but to help and support the patients’ immune system to recognize and attack the tumor more effectively.” The vaccine is personalized because it is developed from samples of tumors removed from each patient. It was in fact prepared overseas by Moderna and then shipped to Italy, precisely to Naples. The same thing will also be done for the other patients enrolled in the Pascale trial. “To date we have screened another 18 candidate patients,” reports Ascierto. The times are therefore quite long. We will have to wait to know if it will work or not. “It will take a few years before we have the results of this last phase of the clinical study”, specifies Ascierto.

Promising results

But expectations are high. The results of the phase II study of the mRNA vaccine, released last December by Moderna and MSD, showed a 44% reduction in the risk of recurrence 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”, confesses Ascierto.

De Renzis, for his part, is very confident and fearless. “I’m not afraid, I trust the science and I trust the colleagues who are following me”, he underlines. “For the same reason, my family is also very calm and aware of what is happening”, he adds.

However, there is great emotion throughout Pascale who enthusiastically welcomed the arrival of the first patient. “We are honored – comments the general director of Pascale, Attilio Bianchi – that Pascale is the first center in Italy to participate in the testing of the first mRNA vaccine against cancer. A completely new frontier is opening up, and we are proud to be protagonists of it.”

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