Moderna and Merck’s Personalized mRNA Cancer Vaccine mRNA-4157/V940 Receives FDA Breakthrough Therapy Designation in Combination with Keytruda for High-Risk Melanoma

On February 22, Moderna/MSD announced that the personalized mRNA cancer vaccine mRNA-4157/V940, co-developed by the two companies and used in combination with MSD's PD-1 monoclonal antibody Keytruda (pembrolizumab), received FDA Breakthrough Therapy Designation as an adjuvant treatment for high-risk melanoma patients following complete resection.

Moderna's personalized cancer vaccine aims to encode neoantigens produced by gene mutations in tumor cells of cancer patients through mRNA. When the mRNA-4157 tumor vaccine is injected into the body, the neoantigen sequences carried by the mRNA will be translated into proteins and stimulate T-cell anti-tumor responses through antigen presentation in the body, inducing tumor-specific responses. According to previous data disclosures, the preparation of this tumor vaccine requires the use of tissue obtained through surgery, with a preparation time of approximately 45 days.

Source: Moderna Official Website

This Breakthrough Therapy Designation is based on the positive data from the Phase IIb study KEYNOTE-942/mRNA-4157-P201. KEYNOTE-942 is a randomized, open-label Phase IIb trial that enrolled 157 patients with stage III/IV melanoma. After complete surgical resection, patients were randomly assigned to receive either mRNA-4157 (for a total of 9 doses in 21-day cycles) in combination with Keytruda (200mg every three weeks for a total of 18 cycles), or Keytruda monotherapy until disease recurrence or intolerable toxicity. The primary endpoint was recurrence-free survival (RFS), and the secondary endpoint was distant metastasis-free survival (DMFS).

On December 13, 2022, Moderna and MSD jointly announced that the Phase IIb KEYNOTE-942 clinical study of their co-developed personalized cancer vaccine mRNA-4157 in combination with Keytruda for adjuvant treatment of high-risk melanoma patients (Stage III/IV) had met its primary efficacy endpoint.

Moderna/MSD will continue to discuss the results with regulatory authorities and initiate a Phase III study for adjuvant treatment of melanoma in 2023. In addition, the two companies also plan to rapidly expand the combination therapy to other tumor treatment studies, including non-small cell lung cancer.

Moderna President Stephen Hoge stated, "The combination of mRNA-4157 and Keytruda has demonstrated the efficacy of investigational mRNA tumor therapy in clinical trials for the first time, and may represent a new frontier in the treatment of melanoma and other tumors. We look forward to sharing the full data results of this study at the upcoming oncology medical conference."

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