(News Bulletin 247) – Moderna and Merck today announced distant metastasis-free survival (DMFS) results from the randomized phase 2b study KEYNOTE-942/mRNA-4157-P201, a clinical trial evaluating the mRNA-4157 (V940), an investigational therapy in combination with Keytruda in patients with resected high-risk melanoma.
mRNA-4157 treatment in combination with Keytruda demonstrated statistically significant and clinically significant improvement in DMFS compared to Keytruda alone and reduced the risk of developing distant metastases or death by 65%.
“These findings add to the emerging picture of how individualized neoantigen therapy can transform melanoma treatment and the promise it may hold for other types of cancer,” said Kyle Holen, vice -Senior President and Head of Development, Therapeutics and Oncology at Moderna.
The U.S. Food and Drug Administration and European Medicines Agency have granted Breakthrough Therapy Designation and Priority Medicines Program (PRIME) designation, respectively, for mRNA-4157 in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma after complete resection.
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