High-risk Melanoma Reduced with Novel mRNA Therapy

Moderna, Inc. and Merck today announced the first presentation of detailed results from the Phase 2b clinical trial evaluating mRNA-4157 (V940).

In the overall intention-to-treat population, adjuvant treatment with mRNA-4157 in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) and reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.309-1.017]; one-sided p value=0.0266) compared with KEYTRUDA alone.

Dr. Kyle Holen, M.D. Moderna's Senior Vice President and Head of Development, Therapeutics, and Oncology commented in a press release on April 16, 2023, "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."

mRNA-4157 is a novel investigational mRNA-based individualized neoantigen therapy consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient's tumor.

Individualized neoantigen therapies prime the immune system so patients can generate a tailored antitumor response specific to their tumor mutation signature.