Health: personalized mRNA vaccine against melanoma cuts recurrence risk by 42% in phase 3 trial

Madrid, Spain — A personalized mRNA vaccine against melanoma reduced the risk of the cancer returning or of death by 42%, compared with immunotherapy alone, according to detailed results from the phase 3 INTerpath-001 clinical trial, presented on Saturday at the European Society for Medical Oncology (ESMO) Congress in Madrid.

The treatment, called intismeran autogene and developed by Moderna and Merck, is tailor-made for each patient: after the tumor is removed, its genetic material is sequenced and up to 34 neoantigens — altered fragments unique to the tumor — are selected to build a messenger RNA molecule that trains T cells to recognize and attack remaining cancer cells. It is combined with pembrolizumab (Keytruda), a drug that releases a brake on the immune system.

The trial enrolled 1,137 patients with completely resected stage IIB to IV melanoma at high risk of recurrence, randomly assigned to the combination or to Keytruda with placebo. With a median follow-up of 24.6 months, the risk of recurrence or death fell 42% (hazard ratio 0.58) and the risk of distant metastasis or death fell 38%. At two years, 82.2% of those who received the combination remained recurrence-free, versus 70.0% with Keytruda alone.

“The transformative INTerpath-001 results have the potential to make a foundational shift in how we treat patients with earlier-stage melanoma,” said lead investigator Professor Georgina Long, of Melanoma Institute Australia, according to the Merck and Moderna statement.

The data do not yet prove the treatment extends life: overall survival data are immature, although the companies report a favorable trend. It is also not a preventive vaccine for healthy people, nor is it FDA-approved: the companies said they are engaging with regulatory authorities and that the results have been accepted for publication in The New England Journal of Medicine. The technology is also being studied in lung and pancreatic cancers.

Photo: Archivo A Lo Claro

Source: CNN