Moderna and Merck Report Progress on Cancer Vaccine

Moderna and Merck have announced positive results from the Phase 2b trial evaluating Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda in patients with high-risk melanoma. The study demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival and reduced the risk of recurrence or death by 44% compared with Keytruda alone.

mRNA-4157 (V940) is an investigational neoantigen therapy that is designed and produced based on the DNA sequence of the patient’s tumor. Individualized neoantigen therapies are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumor. Keytruda is a FDA-approved monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

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% for stage III and 16% for stage IV.

“Today’s results provide further encouragement for the potential of mRNA as an individualized neoantigen therapy to positively impact patients with high-risk resected melanoma,” said Dr. Kyle Holen, M.D. Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology. “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.” (Source: Moderna Website, 16 April, 2023)