NEW YORK – In a newly launched Phase III trial, researchers are assessing the activity of Moderna and Merck's personalized neoantigen cancer vaccine V940 (mRNA-4157) plus Merck's checkpoint inhibitor Keytruda (pembrolizumab) in high-risk melanoma patients following surgery, the two companies said Wednesday.
The randomized Phase III V940-001 clinical trial, which will take place at more than 165 sites in 25 countries, will include 1,089 patients with high-risk stage IIB to IV melanoma. Merck and Moderna said they've begun enrolling patients in Australia.
After surgical resection, patients will receive either the V940-Keytruda combination or Keytruda alone. They will continue treatment in the study for one year or until their cancers recur or they experience unacceptable toxicity. The companies' primary aim in the trial is to evaluate recurrence-free survival, and they will track secondary endpoints including distant metastasis-free survival, overall survival, safety, and quality of life.
The launch of this Phase III trial follows the release of positive data from an earlier Phase IIb trial of the personalized immunotherapy-Keytruda combination. In that study, the addition of the personalized neoantigen vaccine to Keytruda reduced patients' risk of death by 44 percent, and the benefit was seen across patient subgroups.
The combination of Keytruda and the personalized immunotherapy, which involves engineering messenger RNA to target 34 neoantigens based on a patient's unique tumor signature, has breakthrough therapy designation from the US Food and Drug Administration and PRIME designation from the European Medicines Agency. In addition to high-risk melanoma, Merck and Moderna plan to develop this combination in non-small cell lung cancer and other tumor types.