“There is a lot of anticipation” for the results that will emerge from the ongoing tests on the personalized mRNA vaccine against melanoma, i.e. tailor-made for the individual patient's tumor. The UK is also treating its first patients. “The news reported in the UK” talks about the process of a phase 3 study which is now starting in the various countries. We in Italy started in December 2023, the study is progressing. In our country there are 5 centers involved, the “The enrollment is progressing and going very well. Many patients are participating and therefore we expect to have the results within 3 years.” This was presented to Adnkronos Salute the oncologist of the National Cancer Institute Irccs Pascale Foundation of Naples, Paolo Ascierto, director of the Department that deals with skin tumors, experimental oncological immunotherapy and innovative therapies.
“The timetable is respected – the expert points out – and probably the enrollment can be closed even earlier. The process will be further speeded up now with the addition of the United Kingdom, because in this way we will have more patients and this means without other a greater speed” in data collection. “In Italy I believe around fifty patients have already been enrolled, we are ahead and there are many others who are being screened, waiting to see if they can enter the study. Our country's performance is important” on this front.
Going into the merits of the vaccine, “this further innovation is expected” in the world of oncology, reasons the specialist. “The data from the phase 2 study are very promising and therefore there is a lot of waiting. And if the study were to be positive, on the one hand it changes the standard of adjuvant treatment” for melanoma, “but it also opens the door to further trials for other types of tumors. There are already some underway, which are also important. So we will see. It is certainly a very interesting approach to personalize the activity of the immune system.”
This one from Moderna, “which currently has a more advanced development process, would be the first therapeutic vaccine” if the positive data are confirmed. “Its characteristic”, explains Ascierto, “is that the vaccine is produced directly from the patient's tumor. The tumor sample, after it has been removed and analyzed, is sent to a centralized laboratory which extracts all the DNA. The tumor has many mutated proteins, different from normal ones. And each mutated protein corresponds to a mutated gene. So from the DNA of the tumor sample an algorithm selects the neoantigens, i.e. the genes of those mutated proteins typical of the tumor. The algorithm selects 34 of them immunogenic, i.e. capable of activating the immune defense more. The messenger RNA of these 34 antigens is then produced which becomes the vaccine.
This is the path also followed for the Italian patients who were taken care of by the centers involved in the ongoing international trial. “We don't know who got the vaccine and who got the placebo, because the phase 3 study involves enrolling 1,000 patients who get the vaccine and immunotherapy and 500 who get placebo and immunotherapy.” The 71-year-old doctor Alfredo “was the first Italian patient treated, we will know in what way at the end”. What prospects open up now? “For melanoma, if the phase 2 data” made known by Moderna and MSD is confirmed, “i.e. a reduction in the risk of recurrence of 44% and even 76% for the appearance of distant metastases, it is clear that it will be a “further step forward” for the future of treatment and the prospects of these patients, reasons the oncologist.
“At the same time – he continues – this data will encourage further clinical studies in the adjuvant setting, i.e. after surgery in collaboration with classical immunotherapy, with the aim of being able to have better results also for other tumors”. A turning point that lies ahead with the experimental anti-cancer vaccines under study? “We are seeing several turning points – Ascierto points out – If I had to define this vaccine I would define it as 'immunotherapy 4.0', because we have checkpoint inhibitors, we have CAR-Ts, we have Tils (tumor-infiltrating lymphocytes)”. And the fourth 'pillar' could therefore become tailor-made vaccines.
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