Personalised mRNA vaccine mRNA-4157/V940 has demonstrated a clinically meaningful improvement in patients with late-stage melanoma.
The vaccine, in combination with Keytruda, met its primary endpoint of recurrence-free survival (RFS) for the adjuvant treatment of patients with stage III/IV melanoma following complete resection.
Adjuvant treatment with mRNA-4157/V940, which is being developed by Moderna and Merck (MSD), reduced the risk of recurrence or death by 44% compared with Keytruda alone.
“The results of this randomised Phase IIb trial are exciting for the field. These data provide the first evidence that we can improve on the rates of recurrence-free survival achieved by PD-1 blockade in resected high-risk melanoma. These findings also provide the first randomised evidence that a personalised neoantigen approach may be beneficial in melanoma,” said Jeffrey S Weber, principal investigator of the study and Deputy Director of the Perlmutter Cancer Center at NYU Langone.
The companies plan to discuss the results with regulatory authorities and initiate a Phase III study in melanoma patients in 2023.
In October, the companies announced that Merck had exercised its option to jointly develop and commercialise mRNA-4157/V940. Merck and Moderna will share costs and any profits equally under the collaboration.
