Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA

Moderna and Merck announced on Feb. 22, 2023 that their investigational personalized messenger RNA (mRNA) cancer vaccine, mRNA-4157/V940, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy Designation by FDA for the adjuvant treatment of patients with high-risk melanoma following complete resection.

FDA’s decision was based on positive data from the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial. Breakthrough Therapy Designations are granted to accelerate the development and review of drugs that are intended to treat a serious condition, and when preliminary clinical evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint.

“The FDA’s Breakthrough Designation for mRNA-4157/V940 in combination with KEYTRUDA reflects the excitement that we have for the potential promise of individualized cancer treatments,” said Stephen Hoge, Moderna’s President, in a company press release. “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. We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as continuing discussions with health authorities. We are grateful to the FDA for this designation.”