Moderna and Merck announced that the investigational personalized mRNA cancer vaccine mRNA-4157/V940 in combination with the latter’s lung cancer drug KEYTRUDA (pembrolizumab) has been given breakthrough therapy designation by the US Food and Drug Administration (FDA).

The breakthrough therapy designation for the combination is for its use as adjuvant treatment of high-risk melanoma in patients who had a complete resection. It was issued by the FDA based on the positive findings from the ongoing KEYNOTE-942/mRNA-4157-P201 phase 2b trial, which features 157 patients having stage III/IV melanoma.

Stephen Hoge — Moderna President said: “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.”

Moderna and Merck will continue discussing the results of the investigational combination with regulatory bodies. They will also launch a phase 3 clinical trial in adjuvant melanoma this year, and expand rapidly to other types of tumor, including non-small cell lung cancer.

Dr. Eric H. Rubin — Merck Research Laboratories senior vice president of global clinical development said: “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.”

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