Trial: mRNA Vaccine and Drug Cut Melanoma Recurrence Risk by 42%

Personalised mRNA Vaccine Cuts Melanoma Recurrence Risk by 42 Per Cent in Phase III Trial

A custom-made mRNA vaccine combined with the immunotherapy drug pembrolizumab reduces the risk of melanoma recurrence or death by 42 per cent at two years compared to pembrolizumab alone, according to phase III clinical trial results. The Australian-led trial evaluated 1,137 patients whose surgically removed melanoma put them at high risk of relapse. Among participants receiving the dual treatment, 82 per cent remained alive and recurrence-free at two years, compared with 70 per cent of those treated solely with pembrolizumab.

Trial Design and Administration Across 157 Global Sites

Conducted across 157 sites worldwide, the trial enrolled patients who had not previously received any cancer drug treatment. The vaccine is manufactured specifically for each patient to target up to 34 distinct genetic mutations unique to their individual tumour, a method that differs from traditional therapies addressing single gene mutations.

Oncology Experts Praise Findings as Moderna Shares Slide

Prof Georgina Long, medical director at the Melanoma Institute Australia, described the findings as a foundational shift in oncology that allows scientists to harness the immune system in a personalised way. The results were slated for presentation at the European Society for Medical Oncology annual congress in Madrid and accepted for publication in the New England Journal of Medicine pending peer review. Concurrently, vaccine co-developer Moderna experienced significant market volatility, with shares sliding nearly 18 per cent to close at $202.63 following the data release.

Future Research Requirements and Regulatory Timeline

The therapy requires further study and formal regulatory review before it can become a standard treatment option for patients.

Frequently Asked Questions About the Melanoma Vaccine Trial

What exact drug combination was tested in the trial?

Trial participants received a combination of the personalised mRNA vaccine intismeran and the immunotherapy drug pembrolizumab, which is also sold under the brand name Keytruda, compared against pembrolizumab administered alone.

How many patients participated in the research?

The trial included 1,137 patients across 157 clinical sites worldwide who had their melanoma tumours surgically removed and faced a high risk of recurrence.

When and where were the findings presented?

The phase III results were released ahead of a presentation by Prof Georgina Long at the European Society for Medical Oncology annual congress in Madrid, and accepted for publication in the New England Journal of Medicine.