Moderna, Merck granted FDA Breakthrough Therapy Designation for mRNA-4157/V940

Moderna (MRNA) and Merck (MRK) announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the adjuvant treatment of patients with high-risk melanoma following complete resection. The FDA granted Breakthrough Therapy Designation based on positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. "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. 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," said Stephen Hoge, M.D., Moderna’s President. "This is an important milestone in the development of mRNA-4157/V940 in combination with KEYTRUDA. We look forward to working with the FDA, in collaboration with Moderna, to conduct a rigorous and rapid clinical development program with a focus on addressing the needs of this important patient population," said Dr. Eric H. Rubin, senior vice president, global clinical development, Merck Research Laboratories.