Moderna Inc (NASDAQ:MRNA) and Merck & Co Inc (NYSE:MRK) announced follow-up data from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study of mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with Keytruda in patients with resected high-risk melanoma (stage III/IV) following complete resection.
The data builds on the Phase 2 trial that showed that after about two years, recurrence of cancer or death was reported in 22% of patients who got the shot and the immunotherapy Keytruda and in 40% of patients who received immunotherapy alone.
With a median follow-up of approximately three years, adjuvant treatment with mRNA-4157 (V940) in combination with Keytruda continued to demonstrate a clinically meaningful improvement in recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% compared with Keytruda alone.
mRNA-4157 (V940) combined with Keytruda also demonstrated a meaningful improvement in distant metastasis-free survival (DMFS), compared with Keytruda alone, reducing the risk of developing distant metastasis or death by 62%.
The most common side effects of the vaccine after three years were fatigue, injection site pain, and chills.
In July, Moderna and Merck initiated a pivotal Phase 3 INTerpath-001 (V940-001) trial evaluating mRNA-4157 (V940) in combination with Keytruda as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma.
The companies have also initiated a Phase 3 trial in non-small cell lung cancer that is actively enrolling globally (INTerpath-002) and plan to expand the development program to additional tumor types.
Price Action: MRNA shares are up 11.20% at $87.40, and MRK stock is down 0.32% at $106.77 during the premarket session on the last check Thursday.
