An international Phase 3 trial, led in the UK by UCLH, has reported positive early results for a personalised mRNA treatment designed to stop high-risk melanoma returning after surgery.
The INTerpath-001 trial is testing a treatment called intismeran autogene, also known as V940, in combination with the immunotherapy drug pembrolizumab.
Unlike conventional treatments, intismeran is made individually for each patient. Scientists analyse a sample of the patient's tumour and use its unique genetic features to create an mRNA treatment designed to help their immune system recognise and attack their cancer.
The trial sponsors, MSD and Moderna, have announced that the study met its main goal. Patients receiving the personalised treatment alongside pembrolizumab went significantly longer without their melanoma returning than those receiving pembrolizumab alone. The combination also significantly delayed the cancer spreading to other parts of the body.
UCLH coordinated the UK recruitment to the trial, and UK centres went on to recruit nearly 5% of all participants in the global Phase 3 trial. Cancer research at UCLH is led and delivered by first-class teams in clinical and research infrastructure and facilities which benefit from underlying support from the National Institute for Health and Care Research.
Full results, including the size of the benefit, will be presented at the European Society for Medical Oncology (ESMO) Congress in October.
Dr Heather Shaw, UCLH consultant medical oncologist and UK coordinating investigator for INTerpath-001, said: “This is an important moment for melanoma research. For the first time in a Phase 3 trial, we have shown that a treatment designed around the unique mutations in an individual patient's tumour can reduce the risk of their melanoma returning when given alongside pembrolizumab.
“What makes this particularly exciting is that every patient's treatment is individually designed to help their immune system recognise their own cancer.
“We don't yet know the size of the benefit, and we need to see the full results before understanding how this treatment might fit into clinical practice. But this is a significant step forward for personalised cancer treatment.”
The companies said no new safety concerns were identified. Patients in the trial will continue to be followed, including to see whether the treatment helps people live longer.
Melanoma is the most serious form of skin cancer and the fifth most common cancer in the UK, with around 19,400 new cases diagnosed each year.
Surgery can cure many melanomas, but in people with higher-risk disease there remains a risk that the cancer will return. Treatments such as pembrolizumab are already given after surgery to reduce this risk. INTerpath-001 is investigating whether adding a treatment designed specifically for each patient's tumour can reduce that risk further.
Image: Yui Mok/PA
