Personalized mRNA Cancer Vaccine V940 Plus Keytruda Reduces Risk of Recurrence or Death by 49% in High-Risk Melanoma: 3-Year Follow-Up Data from Phase IIb KEYNOTE-942 Trial

On December 14, Merck & Co., Inc. and Moderna, Inc. jointly updated the follow-up data from the Phase IIb KEYNOTE-942/mRNA-4157-P201 study, which evaluated the efficacy and safety of the personalized neoantigen therapy, the tumor mRNA vaccine V940 (mRNA-4157), in combination with pembrolizumab for patients with high-risk melanoma (Stage III/IV) who had undergone complete resection.

In this planned analysis with a median follow-up of approximately 3 years, the adjuvant treatment of V940 combined with pembrolizumab continued to show a clinically meaningful improvement in recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% (HR=0.510 [95% CI: 0.288-0.906]; P=0.0095). The combination of V940 and pembrolizumab also demonstrated a significant improvement in distant metastasis-free survival (DMFS), reducing the risk of distant metastasis or death by 62% compared to pembrolizumab alone (HR=0.384 [95% CI: 0.172-0.858]; P=0.0077).

The adverse events observed with V940 in this study were consistent with previously reported adverse events. After a median planned follow-up of approximately three years, the number of patients reporting treatment-related grade ≥3 adverse events was similar between the two groups (25% in the combination therapy group versus 20% in the monotherapy group). The most common adverse events of any grade attributed to V940 were fatigue (60.6%), injection site pain (56.7%), and chills (49%).

Based on data from the Phase IIb KEYNOTE-942/mRNA-4157-P201 study, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) granted Breakthrough Therapy designation to V940 in combination with pembrolizumab for adjuvant treatment of high-risk melanoma patients.

"As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are pleased to see such significant clinical efficacy with V940 in combination with pembrolizumab as adjuvant therapy for high-risk melanoma patients," said Kyle Holen, M.D., Senior Vice President and Head of Therapeutics and Oncology Development at Moderna. "These data add another positive analysis to the multiple endpoints and subgroups previously evaluated in this study. Importantly for this technology, the KEYNOTE-942/mRNA-4157-P201 study is the first to demonstrate the efficacy of an investigational mRNA cancer therapy in a randomized clinical trial and the first to show a combination therapy that is clearly superior to pembrolizumab alone in the adjuvant treatment of melanoma."

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