The results of the personalised melanoma vaccine will be presented at the european congress of medical oncology
The administration of intismeran, a personalised therapeutic cancer vaccine developed from each patient’s tumour, together with pembrolizumab immunotherapy following surgery for high-risk melanoma, reduced the risk of recurrence or death by 42 per cent. This phase 3 clinical trial, funded by Moderna and Merck Sharp & Dohme, involved 1,137 patients at very high risk of recurrence who had undergone surgical removal of their melanoma. The companies released preliminary data in August in a press release, and the full results are due to be presented this Saturday at the European Society for Medical Oncology (ESMO) Congress being held in Madrid. Ahead of the announcement, the data were leaked yesterday and the share prices of both companies fell. The scientific paper is due to be published in The New England Journal of Medicine.
261023_Eva_vacuna melanoma
Eva Muñoz Couselo
The results of the INTerpath-001 study represent a major breakthrough in the treatment of melanoma and, in particular, in the development of personalised medicine. For the first time, a phase III trial has demonstrated that an individualised therapeutic vaccine, designed on the basis of the molecular characteristics of each patient’s tumour, can significantly improve the outcomes of conventional immunotherapy.
The benefit observed is not only statistically significant but also clinically relevant. The combination of intismeran autogene and pembrolizumab ensures that 82.2 per cent of patients remain relapse-free at two years, compared with 70 per cent of those treated with pembrolizumab alone. Furthermore, a significant reduction in the risk of developing distant metastases has also been observed. However, longer-term follow-up will be required to confirm the duration of this benefit and to assess its potential impact on overall survival.
These results should also be interpreted in the context of the transformation currently taking place in the treatment of melanoma. In recent years, neoadjuvant immunotherapy, administered prior to surgery, has shown extraordinarily promising results in patients with high-risk resectable disease. One of its main advantages is that it allows subsequent treatment to be tailored to the pathological response, thereby avoiding the need for certain patients to continue immunotherapy unnecessarily.
Therefore, although INTerpath-001 sets a new benchmark for the development of personalised adjuvant treatments, we still need to define how these strategies will be integrated into a landscape in which neoadjuvant therapy is playing an increasingly prominent role.
Finally, we must not overlook the challenge of sustainability. Individualised vaccines require complex and predictably costly manufacturing processes. Their incorporation into clinical practice must be accompanied by rigorous cost-effectiveness assessments, taking into account not only the price of the treatment but also its ability to prevent relapses and avoid subsequent treatments.
The real challenge for oncology in the future will not only be to develop increasingly effective treatments, but to identify which patients actually need each treatment, when they should receive it, and for how long. The combination of personalised medicine, neoadjuvant strategies and response-adaptive treatments could enable us to move towards a more effective, less toxic and also more sustainable form of oncology.
[On the share price fall following the leak of trial data] It is a real shame that these results have circulated prematurely on social media, generating numerous comments and interpretations prior to their official presentation at ESMO. I believe that, out of respect for the work of the researchers, the authors and the companies involved, the opportunity to present the full results, contextualise them appropriately and offer a rigorous scientific interpretation should have been preserved. That responsibility lies, first and foremost, with those who conducted the study and those entrusted with its scientific discussion during the congress. Discussion and debate are fundamental to scientific progress, but they should be based on complete and correctly presented data, not on leaked and potentially decontextualised information.
Long et al.
- Non-peer-reviewed
- Communication