The INTerpath-001 trial is evaluating Moderna/Merck’s mRNA-4157 in combination with Merck’s Keytruda.
A phase 3 international trial evaluating a new personalised immunotherapy treatment for melanoma has recruited its first patients at University College London Hospitals (UCLH) NHS Foundation Trust.
Results from the phase 2 study evaluating Moderna and Merck & Co’s – known as MSD outside the US and Canada – mRNA-based technology treatment were published in the Lancet.
Currently the fifth most common type of cancer, melanoma is a serious form of skin cancer that is responsible for over 8,000 new cases every year.
The condition is characterised by the uncontrolled growth of pigment-producing cells.
The new trial, INTerpath-001, is evaluating mRNA-4157 (V940) in combination with Merck’s PD-1 inhibitor, Keytruda (pembrolizumab), versus Keytruda on its own – the current standard of care – as a risk-reducing treatment option for patients with resected, high-risk, stage 2b to 4 melanomas following surgical removal of the cancer, with primary outcomes of recurrence-free survival and overall survival and metastasis-free survival as secondary outcomes.
The personalised treatment is designed to instruct the body to make up to 34 proteins that target neoantigens – proteins found only on cancer cells – identified by gene sequencing that are thought to be driving the cancer in that particular patient.
The neoantigen therapy works to prime the immune system to attack the tumour cells in each patient, while Keytruda works to block an immunological ‘brake’ that protects the cancer.
The phase 3 trial follows the phase 2 KEYNOTE-942 study evaluating V940 plus Keytruda, which demonstrated a 49% reduction in the risk of recurrence or death after three years compared to standard treatment alone among patients with stage 3b to 4 advanced melanomas following surgical removal of the cancer.
Heather Shaw, UCLH consultant medical oncologist, commented: “[The immunotherapy] can prepare the immune system to quickly identify and attack any cancer cells bearing them, with the aim of preventing [the] recurrence of melanoma.”
Researchers hope that the study running across several sites in the UK will confirm findings from the earlier trial and enrol over 1,000 patients worldwide.
