Moderna and Merck – known as MSD outside the US and Canada – have reported promising results from a phase 2b trial of their investigational cancer vaccine in high-risk melanoma patients.
Results from the KEYNOTE-942 trial showed the vaccine, mRNA-4157, in combination with Merck’s Keytruda reduced the risk of death or recurrence by 44% compared with the immunotherapy alone.
The companies have said they will now initiate a phase 3 study of the combination therapy in adjuvant melanoma this year, as well as ‘rapidly expand’ to additional tumour types, including non-small cell lung cancer.
Dr Kyle Holen, Moderna’s senior vice president and head of development, therapeutics and oncology, said: “Today’s results provide further encouragement for the potential of mRNA as an individualised neoantigen therapy to positively impact patients with high-risk resected melanoma.
“The profound observed reduction in the risk of recurrence-free survival suggests this combination may be a novel means of potentially extending the lives of patients with high-risk melanoma. We look forward to starting the phase 3 melanoma trial soon and expanding testing to lung cancer and beyond.”
The vaccine 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 given breakthrough therapy designation in the US as an additional treatment for high-risk melanoma patients.
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 cancers 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 Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said: “This data supports the potential of mRNA-4157 in combination with Keytruda to help fight melanoma earlier and warrants investigation of the combination in a larger phase 3 trial. We also look forward to studying mRNA-4157 and Keytruda in a variety of other early-stage cancers.”Πηγή: pmlive.com