Cutting-edge oncology

Melanoma, mRNA vaccine cuts risk of recurrence by 49% at 5 years

The secret of success lies in absolute customisation. Ascierto: 'A long-awaited milestone, soon the data of the ongoing study in Italia'

by Health Review

3' min read

Translated by AI
Versione italiana

3' min read

Translated by AI
Versione italiana

 

The new data indicate that the efficacy of the vaccine combined with immunotherapy not only reduces the risk of the tumour returning but also cuts the risk of distant metastasis by 59%. To date, 92.2% of patients given the vaccine are alive at five years, compared to 71.3% in the control group

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The data

It is no longer just a promise, but an established clinical reality: the 5-year results of the Phase 2b Keynote-942 study confirm the robustness and durability of the customised mRNA vaccine against melanoma. The data, presented by researchers from NYU Langone Health at the American Society of Clinical Oncology (Asco) congress in Chicago, and published simultaneously in the Journal of Clinical Oncology, certify an extraordinary achievement: the combination of the personalised anti-cancer vaccine (intismeran) and standard immunotherapy (pembrolizumab) reduces the risk of recurrence or death by 49% compared to immunotherapy alone in patients with high-risk melanoma. In Italia, as well as in other parts of the world, the phase 3 study, first initiated at the Pascale Institute in Naples by Paolo Ascierto, professor of Oncology at the Federico II University in Naples and president of the Fondazione Melanoma Onlus, is underway.

 

The Right Way

"The results presented at the Asco confirm that the path taken with the mRNA vaccine is the right one and that the efficacy of the combination with immunotherapy remains constant over time," Ascierto comments. "Reducing the risk of recurrence by 49% and the risk of metastasis by 59% after five years opens up very important clinical prospects for the future of high-risk patients. The study involved 157 operated melanoma patients divided into two groups to assess the effectiveness of adjuvant (post-surgical) therapy. 'Five years after surgery, 68.8% of patients treated with the vaccine plus immunotherapy combination were completely tumour-free, compared to 49.1% of those who received immunotherapy alone,' Ascierto reports. 'In addition, the combination reduced the risk of the melanoma spreading to other organs of the body by 59%. But perhaps the most impressive finding is that 92.2 per cent of patients in the vaccine group were alive at five years, compared to 71.3 per cent in the control group'.

Customised Therapy

 

The secret of the tested cancer vaccine's success lies in its absolute customisation. 'This is not a traditional preventive vaccine, but a therapy 'tailor-made' for each individual patient,' explains Ascierto. 'Through the analysis of the tumour that was surgically removed, up to 34 neoantigens were identified, i.e. the specific and exclusive protein 'signatures' of that particular melanoma. On the basis of this information, an mRNA strand was synthesised which, once injected, instructs the T lymphocytes, i.e. the soldiers of the immune system, to recognise and destroy any residual tumour cells attempting to hide or reproduce themselves'. Immunotherapy with pembrolizumab removes the 'brake' on the immune system that the tumour uses to defend itself; the intismeran vaccine, on the other hand, gives the T-lymphocytes the exact identikit of the target to hit.

 

"A new era"

The results of the study open the door to a new era in cancer medicine. 'The safety of the treatment is now proven, with absolutely manageable side effects that can be superimposed on those of a normal flu reaction,' Ascierto concludes. 'The international Phase 3 trial is already underway and sees Italia playing a leading role. But the real news is that this approach leads the way: mRNA technology applied to high-mutation tumours, such as melanoma, is already being successfully tested for lung cancer and other difficult-to-treat neoplasms. We are facing a potential paradigm shift: if the Phase 3 data confirm these trends, precision medicine will become an established therapeutic standard for these diseases'.

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