Moderna, Merck announce 3-year data for mRNA-4157 in combination with Keytruda

Moderna (MRNA) and Merck (MRK) announced the first presentation of results from a planned analysis from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157, or V940, an investigational individualized neoantigen therapy, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma following complete resection. With a median follow-up of approximately three years, adjuvant treatment with mRNA-4157 in combination with KEYTRUDA continued to demonstrate a clinically meaningful and durable improvement in recurrence-free survival, or RFS, the primary endpoint of the study, reducing the risk of recurrence or death by 49% compared with KEYTRUDA alone. mRNA-4157 in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival, or DMFS, a key secondary endpoint of the study, compared with KEYTRUDA alone, reducing the risk of developing distant metastasis or death by 62%. These data are being presented today during a rapid oral abstract session at the 2024 American Society of Clinical Oncology, or ASCO, Annual Meeting. With an additional year of planned follow-up, these data build on the earlier analysis of the primary and key secondary endpoints of the study, presented in 2023. The 2.5-year recurrence-free survival rate of mRNA-4157 in combination with KEYTRUDA was 74.8%, as compared to 55.6% for KEYTRUDA alone, with the benefit observed across exploratory subgroups. “We are encouraged by the latest results from the KEYNOTE-942/mRNA-4157-P201 study. These data highlight the sustained benefit in RFS and DMFS of mRNA-4157 as adjuvant treatment in combination with KEYTRUDA in people with resected high-risk melanoma. Importantly, this benefit was observed across various patient exploratory subgroups, reflecting the potential of mRNA-4157 for a broad range of these patients. These findings reinforce our commitment to advancing this innovative treatment in collaboration with Merck, and we are dedicated to harnessing mRNA technology to potentially transform cancer therapy and improve patient outcomes,” said Kyle Holen, M.D., Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology.