Merck (MSD) and Moderna are initiating a Phase III trial evaluating V940, an investigational individualised neoantigen therapy (INT), in combination with Keytruda, to treat patients with resected high-risk (Stage IIB-IV) melanoma.
Global recruitment has begun for the randomised Phase III trial V940-001 (NCT05933577). It is a randomised, double-blind, placebo and active-comparator-controlled study designed to evaluate the safety and efficacy of V940 (mRNA-4157) in combination with Keytruda (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with resected high-risk melanoma compared to Keytruda alone.
The trial will enrol approximately 1,089 patients at more than 165 sites across the globe. Patients will receive the intervention after complete resection.
Participants over 18 years old will be randomised 2:1 to receive V940 (1mg every three weeks for up to nine doses) and Keytruda (400mg every six weeks for up to nine cycles for approximately one year) versus Keytruda alone for approximately one year until a treatment duration of approximately 56 weeks, disease recurrence or unacceptable toxicity.
The primary endpoint of the study is recurrence-free survival, while the secondary endpoints are distant metastasis-free survival, overall survival and safety.
What V940 does
V940 stimulates an immune response by generating T-cell responses based on the unique mutation of the tumour. Keytruda is an immunotherapy that increases the ability of the body’s immune system to detect and fight tumour cells.
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By GlobalDataMSD senior vice-president and Merck Research Laboratories’ head of late-stage oncology, global clinical development Dr Marjorie Green 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 III trial represents an important step forward in these efforts and our study of individualised neoantigen therapy.”
While Moderna‘s senior vice-president and head of development, therapeutics and oncology Dr Kyle Holen added: “The initiation of the V940-001 Phase III 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.”
Positive results from Phase IIb study
The Phase III study comes after a positive primary analysis of the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial reported at the annual American Association for Cancer Research (AACR) and American Society of Clinical Oncology (ASCO) meetings earlier this year. The US Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines (PRIME) scheme, respectively.
The companies have future plans to expand the development to additional tumour types, including non-small cell lung cancer.
