Merck and Moderna announced the start of a late-stage trial combining V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), and KEYTRUDA, Merck’s anti-PD-1 therapy, as a cancer vaccine on Wednesday. V940-001 global recruitment has begun, with the first patients enrolling in Australia.
Merck and Moderna late-stage trial
“As we continue our efforts to advance novel treatment options for patients with high-risk Stage IIB-IV melanoma, the initiation of the Merck and Moderna Phase 3 trial represents an important step forward in these efforts and our study of individualized neoantigen therapy,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories.
“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.”
“The initiation of the Merck and Moderna 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 individualized neoantigen therapy may potentially transform the treatment of the most serious form of skin cancer,” said Kyle Holen, M.D., Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology.
“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, randomized, double-blind, placebo- and active-comparator-controlled study designed to compare the safety and efficacy of V940 (mRNA-4157) in people with resected high-risk (Stage IIB-IV) melanoma to KEYTRUDA alone.
The trial will enroll approximately 1,089 patients at over 165 sites in over 25 countries worldwide. The study’s primary endpoint is recurrence-free survival (RFS), with secondary endpoints including distant metastasis-free survival (DMFS), overall survival (OS), and safety.
Based on data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, the US Food and Drug Administration and the European Medicines Agency granted V940 (mRNA-4157) Breakthrough Therapy Designation and the Priority Medicines (PRIME) scheme, respectively, for the adjuvant treatment of patients with high-risk melanoma.
The companies presented the study’s primary endpoint, RFS, at the American Association for Cancer Research (AACR) Annual Meeting in April 2023, and its key secondary endpoint, DMFS, at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2023. The companies also intend to broaden the development program to include non-small cell lung cancer.
- Concerning V940 (mRNA-4157)
V940 (mRNA-4157) is a novel investigational messenger ribonucleic acid (mRNA)-based individualized neoantigen therapy (INT) consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the patient’s tumor’s unique mutational signature.
After being administered into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and go through natural cellular antigen processing and presentation, which is an important step in adaptive immunity.
Individualized neoantigen therapies are intended to train and activate the immune system so that a patient’s antitumor response is specific to their tumor mutation signature.
V940 (mRNA-4157) is intended to stimulate an immune response by eliciting specific T-cell responses based on a patient’s tumor’s unique mutational signature.
KEYTRUDA is an immunotherapy that works by increasing the body’s immune system’s ability to detect and fight tumor cells.
Combining V940 (mRNA-4157) with KEYTRUDA may provide an additive benefit over KEYTRUDA alone, according to early clinical studies and data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial.
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