Merck & Co Inc MRK and Moderna Inc MRNA initiated a pivotal Phase 3 randomized V940-001 trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Keytruda, as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma.
Global recruitment in V940-001 has begun, and the first patients are now enrolling in Australia. The trial is slated to enroll approximately 1,089 patients.
The primary endpoint of the study is recurrence-free survival (RFS), and secondary endpoints include distant metastasis-free survival (DMFS), overall survival (OS), and safety.
Based on data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, the FDA and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines scheme, respectively, for V940 (mRNA-4157) in combination with Keytruda as adjuvant treatment for high-risk melanoma.
In December 2022, Moderna and Merck announced that the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940 combined with Keytruda met its primary endpoint.
Adjuvant treatment with mRNA-4157/V940/Keytruda combo reduced the risk of recurrence or death by 44% compared with Keytruda alone.
The companies also plan to expand the development program to additional tumor types, including non-small cell lung cancer.
Price Action: MRNA shares are down 1.46% at $120.09, and MRK shares are up 0.18% at $107.71 on the last check Wednesday.
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