FDA official announcements and press releases

Moderna and Merck Shares Rise on Positive KEYNOTE-942 Melanoma Therapy Results

Jun 3, 2024, 03:52 PM

Moderna and Merck have announced promising results from a Phase 2b clinical trial involving their investigational individualized neoantigen therapy, mRNA-4157 (V940), in combination with Merck's immunotherapy drug KEYTRUDA (pembrolizumab). The trial, known as KEYNOTE-942, included patients with high-risk stage III/IV melanoma following complete resection and demonstrated a sustained improvement in recurrence-free survival and distant metastasis-free survival compared to KEYTRUDA alone. Over a period of 34.9 months, the combination therapy reduced the risk of recurrence or death by 49% and the risk of distant metastasis by 62%, with a hazard ratio for recurrence-free survival of 0.51 and distant metastasis-free survival of 0.38. These findings were presented at the ASCO24 conference, and the companies have indicated that a Phase 3 trial is ongoing. The positive results have led to a rise in the shares of both Moderna and Merck.