Moderna and Merck Combined Therapy Cuts Melanoma Recurrence in Half

Moderna and Merck have announced follow-up data from the Phase 2b clinical trial evaluating Moderna’s investigational INT (individualized neoantigen therapy) mRNA-4157 (V940) in combination with Merck’s Keytruda in patients with high-risk melanoma (Stage III/IV) following surgery. Treatment with the combination therapy reduced the risk of recurrence or death by 49% and the risk of developing distant metastasis or death by 62%, compared with Keytruda alone.

INTs are designed to train and activate an antitumor 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.

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 2023.

Based on data from the Phase 2b study, the FDA and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines (PRIME) scheme, respectively, for the combination therapy for the adjuvant treatment of patients with high-risk melanoma.

In July, Moderna and Merck announced the initiation of a pivotal Phase 3 randomized clinical trial evaluating the combination therapy in patients with resected high-risk (Stage IIB-IV) melanoma. The companies have also initiated a Phase 3 trial in non-small cell lung cancer and plan to expand the development program to additional tumor types. (Source: Moderna Website, 14 December, 2023)