===Moderna (MRNA), Merck (MRK) vaccine with Keytruda cuts risk of deadly skin cancer returning in half

 

Moderna and Merck (MRK) announce mRNA-4157 in combination with Keytruda demonstrated continued improvement in recurrence-free survival and distant metastasis-free survival in patients with high-risk stage III/IV melanoma following complete resection versus Keytruda at three years 

• Co announced follow-up data from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection. In this planned analysis occurring with a median follow-up of approximately three years, adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA continued to demonstrate a clinically meaningful improvement in recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% (HR=0.510 [95% CI, 0.288-0.906]; one-sided nominal p=0.0095) compared with KEYTRUDA alone. mRNA-4157 (V940) in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), compared with KEYTRUDA alone, reducing the risk of developing distant metastasis or death by 62% (HR=0.384 [95% CI, 0.172-0.858]; one-sided nominal p= 0.0077).
• Adverse events observed with mRNA-4157 (V940) in KEYNOTE-942 remain consistent with those previously reported. At a median planned follow-up of approximately three years, the number of patients reporting treatment-related Grade = 3 adverse events were similar between the arms (25% for mRNA-4157 (V940) in combination with KEYTRUDA vs 20% for KEYTRUDA alone). The most common adverse events of any grade attributed to mRNA-4157 (V940) were fatigue (60.6%), injection site pain (56.7%), and chills (49%).
• Based on data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, the U.S. Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines (PRIME) scheme, respectively, for mRNA-4157 (V940) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma. The companies previously presented data on the study's primary analysis with a median planned follow-up of approximately two years. The study's primary endpoint, RFS, was presented in April 2023 at the American Association for Cancer Research (AACR) Annual Meeting, and the study's secondary endpoint, DMFS, data was presented in June 2023 at the American Society of Clinical Oncology (ASCO) Annual Meeting. Data from the primary analysis has been submitted for publication in a peer-reviewed journal.