Moderna and Merck & Co – known as MSD outside the US and Canada – have said they have begun enrolling patients to a late-stage study of their investigational skin cancer vaccine.
The phase 3 V940-00 trial is designed to evaluate the safety and efficacy of the vaccine candidate, V940 (mRNA-4157), in combination with Merck’s Keytruda (pembrolizumab) compared to the anti-PD-1 therapy alone in around 1,089 patients with resected high-risk, stage 2b to 4 melanoma.
The primary endpoint of the trial is recurrence-free survival, the companies outlined, with overall survival and metastasis-free survival as secondary endpoints.
V940 is designed to stimulate an immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumour, while Keytruda increases the ability of the body’s immune system to help detect and fight tumour cells.
The combination has already been shown in a mid-stage study to cut the risk of recurrence or death of melanoma by 44% compared to Keytruda alone.
The regimen has also been given breakthrough therapy designation in the US as an additional treatment for high-risk melanoma patients.
Kyle Holen, Moderna’s senior vice president and head of development, therapeutics and oncology, said: “The initiation of the V940-001 phase 3 trial is an exciting and important milestone for us as we work with our colleagues at Merck and the melanoma patient community to investigate how individualised neoantigen therapy may potentially transform the treatment of the most serious form of skin cancer.”
The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.
In the US, where skin cancer is one of the most common types of cancer diagnosed, it is estimated there will be nearly 100,000 new cases of melanoma and almost 8,000 deaths each year resulting from the disease.
Dr Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories, said: “As we continue our efforts to advance novel treatment options for patients with high-risk stage 2B to 4 melanoma, the initiation of the V940-001 phase 3 trial represents an important step forward in these efforts and our study of individualised neoantigen therapy.”