Moderna, Merck's mRNA cancer vaccine/Keytruda combo gets FDA breakthrough therapy tag
Artur Plawgo


The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to Moderna (NASDAQ:MRNA) and Merck's (NYSE:MRK) personalized mRNA cancer vaccine mRNA-4157/V940, in combination with Keytruda, for the adjuvant treatment of patients with high-risk melanoma after complete resection.
The FDA's decision was backed by data from a phase 2b trial, dubbed KEYNOTE-942/mRNA-4157-P201.

In the study, the combo helped cut the risk of recurrence or death by 44%, versus Keytruda alone, in patients with melanoma, a type of skin cancer.
Moderna's President Stephen Hoge said, "mRNA-4157/V940 in combination with KEYTRUDA provided the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and potentially represents a new frontier in treating melanoma and other cancers."
The companies noted that they will continue to discuss the results with regulatory authorities, start a phase 3 trial in adjuvant melanoma in 2023, and expand to additional tumor types, including non-small cell lung cancer.
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