Novel mRNA Skin Cancer Vaccine Combo Launches Phase 3 Study

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck today announced the initiation of the pivotal Phase 3 randomized V940-001 clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma.

INTs are designed to train and activate the immune system so that a patient can generate an antitumor response specific to their tumor mutation signature.

V940-001 is the first Phase 3 study of a planned comprehensive clinical development program initiated following the positive primary analysis of the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. 

Global recruitment in V940-001 has begun, and the first patients are now enrolling in Australia.

"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 individualized neoantigen therapy may potentially transform the treatment of the most serious form of skin cancer," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology, in a press release on July 26, 2023.

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells.

Nearly 325,000 new cases were 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 2023.