FDA Grants Keytruda, Cancer Vaccine Combo Breakthrough Therapy Designation for Melanoma


The designation is based on study findings demonstrating that the cancer vaccine-Keytruda combination reduces the risk of recurrence or death by 44% in the adjuvant setting for patients with melanoma.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, combined with a PD-1 therapy, Keytruda (pembrolizumab), for the adjuvant treatment (treatment given after primary treatment to lower the risk of recurrence) for patients with high-risk melanoma following complete resection.

The FDA grants Breakthrough Therapy Designation to expedite the development and review of a drug that is intended to treat a serious condition, according to a press release from Merck, the manufacturer of Keytruda. This designation is granted when there is clinical evidence which indicates that drug may have demonstrated substantial improvements over other available therapies.

“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 Dr. Stephen Hoge, the president of Moderna, who manufacturers the cancer vaccine, in the 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.”

This designation is based on positive data from the phase 2b KEYNOTE-942/mRNA-4157-P201 trial, which demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival (the time after primary treatment ends that a patient survives without signs or symptoms of the cancer) with the combination. Adjuvant treatment with the mRNA-4157/V940 and Keytruda also reduced the risk of recurrence or death by 44%.

The companies are continuing to discuss the results and plan to initiate a phase 3 study in the adjuvant setting for melanoma this year, while also investigating the combination in other tumor types such as non-small cell lung cancer.

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