Merck, Moderna announce results from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial

Moderna (MRNA) and Merck (MRK) announced the first presentation of detailed results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating mRNA-4157, an investigational individualized neoantigen therapy, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma. In the overall intention-to-treat population, adjuvant treatment with mRNA-4157 in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival, and reduced the risk of recurrence or death by 44% compared with KEYTRUDA alone. Based on data from KEYNOTE-942/mRNA-4157-P201, the U.S. Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the PRIME scheme, respectively, for mRNA-4157 in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma following complete resection. Additional data from KEYNOTE-942/mRNA-4157-P201 will be shared at an upcoming medical meeting and published in a peer-reviewed publication. The companies previously announced positive data from this study in December 2022. Adverse events reported with mRNA-4157 in KEYNOTE-942 were consistent with those previously observed in a Phase 1 clinical trial. The safety profile of KEYTRUDA was consistent with findings from previous studies.