Australian-led trial delivers world-first results for mRNA cancer vaccine

Australia is at the centre of a transformative advance in melanoma treatment, with dermatologist and researcher Professor Georgina Long leading a global clinical trial that will reshape care for patients with high-risk disease.

Melanoma rates in Australia are among the highest in the world, while the disease remains one of the leading causes of cancer death among younger people.

The personalised vaccine intismeran autogene*, developed by Moderna and MSD and administered in combination with Keytruda (pembrolizumab), has delivered the first positive result from a late-stage clinical trial of an mRNA cancer treatment.

“The results represent a landmark moment for adjuvant melanoma treatment,” said Professor Long, the trial’s principal investigator and a clinician researcher at Melanoma Institute Australia.

The INTerpath-001 trial is the first Phase 3 study to demonstrate that the intismeran autogene combination therapy, designed around the unique mutational ‘fingerprint’ of an individual patient’s tumour, can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared with Keytruda alone.

“For patients with high-risk melanoma, that is a meaningful step forward,” emphasised Professor Long.

Intismeran autogene is manufactured individually for each patient. Researchers first sequence a sample of the patient’s tumour to identify mutations unique to their cancer. They then develop a synthetic mRNA therapy encoding up to 34 of those tumour markers, known as neoantigens.

The aim is to train the patient’s immune system to recognise and attack cancer cells carrying those specific mutations. Keytruda works alongside the personalised vaccine by helping the immune system target cancer more broadly, creating a complementary approach to eliminating residual disease following surgery.

The full results of the trial will be presented at the European Society for Medical Oncology Congress (ESMO) in October.

“MSD and Moderna will then submit the data to regulatory authorities, including Australia’s Therapeutic Goods Administration (TGA), for review,” Professor Long said. “That process can take anywhere between 12 and 24 months. If approved, a separate Pharmaceutical Benefits Scheme (PBS) review would follow before the treatment becomes publicly subsidised in Australia. We are encouraged by the results, but there are important steps still to come.”

*alternatively known as V940 or mRNA-4157

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