- Moderna Inc MRNA and Merck & Co Inc MRK announced the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940 combined with Keytruda met its primary endpoint.
- Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial.
- In October, Merck exercised its option to develop and commercialize mRNA-4157/V940 jointly with Moderna and share costs and profits equally under the worldwide collaboration.
- The investigational personalized mRNA cancer vaccine + Keytruda demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) versus Keytruda alone for the adjuvant treatment of stage III/IV melanoma following complete resection.
- Adjuvant treatment with mRNA-4157/V940/Keytruda combo reduced the risk of recurrence or death by 44% compared with Keytruda alone.
- The companies plan to discuss the results with regulatory authorities and initiate a Phase 3 study in melanoma patients in 2023, rapidly expanding to additional tumor types.
- Price Action: MRNA shares are up 8.70% at $170.50, and MRK shares are up 1.85% at $110.99 during the premarket session on the last check Tuesday.
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