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Merck, Moderna Begin Studying Neoantigen Vaccine With Keytruda as Adjuvant NSCLC Therapy

NEW YORK – Merck and Moderna on Monday announced they have enrolled the first non-small cell lung cancer patient into the Phase III INTerpath-002 clinical trial of the firms' personalized neoantigen vaccine V940 plus Merck's immune checkpoint inhibitor Keytruda (pembrolizumab).

In the trial, Merck and Moderna are studying the combination of V940, also called mRNA-4157, and Keytruda as an adjuvant treatment for NSCLC patients whose cancers are stage II, IIIA, or IIIB with nodal involvement and have been completely resected.

The companies will randomize 868 NSCLC patients to receive either the personalized neoantigen vaccine plus Keytruda or Keytruda alone. Merck and Moderna will compare patients' disease-free survival in the two treatment arms as the primary endpoint as well as overall survival, distant metastasis-free survival, lung cancer specific survival, safety, and quality of life as secondary endpoints.

Merck and Moderna are also studying V940 plus Keytruda as an adjuvant treatment for high-risk melanoma patients in the Phase III INTerpath-001 study. Treatment with the personalized vaccine involves identifying a unique mutational signature from a patient's resected tumor and encoding the vaccine to target 34 individualized neoantigens. The approach has shown promise in earlier-phase trials.

The Phase III melanoma study, for instance, follows positive data from a Phase IIb trial, in which adding V940 to adjuvant Keytruda reduced patients' risk of death by 44 percent.

Merck and Moderna have said they plan to continue expanding their personalized vaccine development into additional tumor types.