V940-001 is the first phase 3 study of a planned comprehensive clinical development program being initiated following the positive primary analysis of the phase 2b KEYNOTE-942/mRNA-4157-P201 trial reported at AACR and ASCO earlier this year
Merck known as MSD outside of the United States and Canada, and Moderna has announced the initiation of the pivotal phase 3 randomised V940-001 clinical trial evaluating V940 (mRNA-4157), an investigational individualised neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma. Global recruitment in V940-001 has begun, and the first patients are now enrolling in Australia.
Dr Marjorie Green, Senior Vice President and Head of late-stage oncology, global clinical development, Merck Research Laboratories said, “As we continue our efforts to advance novel treatment options for patients with high-risk Stage IIB-IV melanoma, the initiation of the V940-001 phase 3 trial represents an important step forward in these efforts and our study of individualised neoantigen therapy. We look forward to continuing to collaborate with Moderna to evaluate this promising new approach with V940 (mRNA-4157), while also building on a standard of care laid by KEYTRUDA.”
Kyle Holen, Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology said, “The initiation of the V940-001 phase 3 trial is an exciting and important milestone for us as we work with our colleagues at Merck and the melanoma patient community to investigate how individualised neoantigen therapy may potentially transform the treatment of the most serious form of skin cancer. We thank the patients, investigators, and clinical trial sites across the world for helping us advance our efforts in this area.”
V940-001 is a phase 3 global, randomised, double-blind, placebo- and active-comparator-controlled study designed to evaluate the safety and efficacy of V940 (mRNA-4157) in combination with KEYTRUDA in people with resected high-risk (Stage IIB-IV) melanoma compared to KEYTRUDA alone. The trial is slated to enroll approximately 1,089 patients at more than 165 sites in over 25 countries around the world. The primary endpoint of the study is recurrence-free survival (RFS), and secondary endpoints include distant metastasis-free survival (DMFS), overall survival (OS), and safety.
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 V940 (mRNA-4157) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma. The companies presented the study’s primary endpoint, RFS, in April 2023 at the American Association for Cancer Research (AACR) Annual Meeting and presented the study’s key secondary endpoint, DMFS, in June 2023 at the American Society of Clinical Oncology (ASCO) Annual Meeting. The companies also plan to expand the development program to additional tumor types, including non-small cell lung cancer.