The trial is testing intismeran autogene (V940), an experimental messenger RNA (mRNA) therapy developed by Moderna in partnership with Merck, known as MSD outside the United States.

Trial success

In contrast to vaccines designed to prevent infection, this treatment is intended for people who already have cancer, as it uses genetic information from a patient’s tumour and seeks to train the immune system to recognise and attack cancer cells.

Moderna and Merck announced this week that their Phase 3 INTerpath-001 trial met its two main objectives, showing a statistically significant improvement in recurrence-free survival and distant metastasis-free survival when V940 was combined with the immunotherapy pembrolizumab, marketed as Keytruda.

This international study involved 1,137 patients with high-risk melanoma, whose tumours had been surgically removed, and who received either the personalised mRNA treatment alongside pembrolizumab or pembrolizumab alone.

Experimental treatment

The companies have not yet released the full Phase 3 results, saying the detailed data will be presented at a forthcoming medical meeting, which means the treatment remains experimental and is not currently available as a standard therapy.

As reported by Executive Digest, in the preceding Phase 2b study, the combination of V940 and pembrolizumab reduced the risk of recurrence or death by 49 percent and the risk of distant metastasis or death by 62 percent, compared with pembrolizumab alone.

The vaccine is manufactured according to the individual characteristics of each patient’s tumour.

Scientists first analyse the tumour to identify mutations that could produce neoantigens, which are abnormal markers that distinguish cancer cells from healthy tissue, and the vaccine then uses mRNA to instruct the immune system to target those specific markers.

Clinical data

This approach represents one of the most closely watched applications of mRNA technology beyond infectious diseases.

The technology became widely known through COVID-19 vaccines, but researchers have since investigated its potential in cancer treatment.

These latest results could pave the way for regulatory submissions, although approval will depend on a detailed assessment of the complete clinical data, and reports suggest the companies are already preparing for discussions with regulators.

Routine practice

For the three patients at IPO Lisbon, participation in the international study gives Portugal a direct role in testing a treatment that could eventually bring personalised cancer therapy closer to routine clinical practice.

The researchers are also investigating similar mRNA-based approaches against other cancers, raising the possibility that personalised vaccines could eventually become part of a broader shift towards treatments designed around the biological characteristics of each individual tumour.