Merck and Moderna's melanoma vaccine becomes first mRNA cancer therapy approved in Phase 3 trial

US pharmaceutical giants Merck and Moderna announced Wednesday that their experimental melanoma vaccine delivered statistically significant improvements when combined with existing cancer treatment, marking the first successful Phase 3 trial for an mRNA-based cancer therapy.

The vaccine, intismeran autogene, showed "statistically significant and clinically meaningful improvements" for skin cancer patients when administered alongside Merck's Keytruda treatment, according to a joint statement from both companies.

First mRNA Cancer Therapy Success

The trial results represent a watershed moment for oncology research. "This represents the first positive Phase 3 readout for an individualised neoantigen therapy (INT) and for an mRNA-based cancer therapy," the companies said. The breakthrough leverages messenger RNA technology, the same platform that proved highly effective against severe Covid-19 infections.

How the Treatment Works

Unlike conventional vaccines designed to prevent disease, intismeran autogene functions as a therapeutic vaccine that treats existing melanoma by training the patient's immune system to target tumours and other invaders. This personalised approach tailors the treatment to each patient's specific cancer profile.

Market Responds

Financial markets reacted sharply to the announcement, with Moderna shares surging more than 90 per cent to around US$120 in early New York trading Wednesday. Merck stock climbed 10 per cent on the same news.

The positive Phase 3 results potentially clear regulatory pathways toward approval, though neither company specified a timeline for seeking authorisation.

Source: South China Morning Post