THEMelanoma is less scary today. The new data presented atASCO, American Society of Clinical Oncology of Chicago are very encouraging. It is no longer just a promising prospect, but a clinical result confirmed over time. The vaccine, used together with immunotherapynot only reduces the risk of the disease returning, but it also reduces the risk of developing distant metastases by 59%.. Furthermore, after five years, 92.2% of patients who received the vaccine are alive, compared to 71.3% of those in the control group.
Melanoma: the study
The 5-year results of the phase 2b KEYNOTE-942 study confirm that the personalized mRNA vaccine against melanoma maintains its efficacy over time. This is demonstrated by the data presented by researchers at NYU Langone Health in Chicago and published simultaneously on the Journal of Clinical Oncology. In Italyas in other countries, the phase 3 study is currently underway. The first center to start it was thePascale Institute of Naplesunder the guidance of Paolo AsciertoProfessor of Oncology at the University Frederick II of Naples and president of Melanoma Foundation Onlus.
Melanoma: “impressive” results
«The results presented at ASCO confirm that the path taken with the mRNA vaccine is the right one and that the effectiveness of the combination with immunotherapy remains constant over time. Reduce the risk of recurrence by 49% and the risk of metastasis by 59%. after five years it opens up very important clinical perspectives for the future of high-risk patients”, comments the Professor Ascierto. The study involved 157 patients with melanoma operated on, divided into two groups to evaluate the effectiveness of adjuvant (post-surgical) therapy.
«Five years after the operation, 68.8% of patients treated with the vaccine plus immunotherapy combination are completely tumor-freecompared to 49.1% of those who received immunotherapy alone. Furthermore, the combination it reduced the risk of melanoma spreading to other organs in the body by 59%.. But perhaps the most impressive fact is that 92.2% of patients in the vaccine group are alive at five yearscompared to 71.3% in the control group”, he underlines Asciert.
A personalized vaccine
The secret to the success of the tested cancer vaccine lies in absolute customization. «This is not a traditional preventive vaccine, but a ‘tailor-made’ therapy for each individual patient. Through analysis of the surgically removed tumor, up to 34 neoantigens were identifiedi.e. the specific and exclusive protein ‘signatures’ of that specific melanoma. Based on this information, a strand of mRNA was synthesized that, when injected, instructs T cellsthat is, the soldiers of the immune system, to recognize and destroy any residual tumor cell that tries to hide or reproduce”, explains the Professor Ascierto. Immunotherapy with pembrolizumab it removes the “brake” from the immune system that the tumor uses to defend itself. The vaccine instead, they become irritated provides the T lymphocytes with the exact identikit of the target to hit.
A new era of oncology
The results of the study open the doors to a new era of oncology medicine. «The safety of the treatment is now proven, with side effects that are absolutely manageable and comparable to those of a normal flu reaction. The Phase 3 international trial is already underway and sees Italy as a strong protagonist. But the real news is that this approach leads the way: mRNA technology applied to tumors with a high mutation ratelike melanoma, is already being tested successfully too for lung cancer and other neoplasms difficult to treat. We are facing a potential paradigm shift: if the Phase 3 data confirm these trends, precision medicine will become a consolidated therapeutic standard for these pathologies.” concludes Professor Ascierto.