Moderna’s mRNA Cancer Vaccine Shows Promise

Moderna and Merck have announced that the Phase 2b trial of their investigational personalized mRNA melanoma cancer vaccine (mRNA-4157/V940) in combination with Merck’s Keytruda demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival versus Keytruda alone. These results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial.

“Today’s results are highly encouraging for the field of cancer treatment. mRNA has been transformative for COVID-19, and now, for the first time ever, we have demonstrated the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma,” said Stéphane Bancel, Moderna’s Chief Executive Officer.

Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumor mutation signature. mRNA-4157/V940 is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumor. Keytruda is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

In October of this year, the companies announced that Merck had exercised its option to jointly develop and commercialize mRNA-4157/V940. Merck and Moderna will share costs and any profits equally under this worldwide collaboration. The companies plan to discuss the results with regulatory authorities and initiate a Phase 3 study in melanoma patients in 2023.

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020. In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be nearly 100,000 new cases of melanoma diagnosed and almost 8,000 deaths resulting from the disease in the U.S. in 2022. The five-year survival rates are estimated to be 60.3% for stage III and 16.2% for stage IV. (Source: Moderna Website, 13 December, 2022)