Moderna and Merck near first approval for mRNA cancer vaccine
Moderna and Merck announced positive Phase 3 clinical trial results for their personalized melanoma treatment, "intismeran autogene," developed by Moderna and administered with Merck's immunotherapy Keytruda. This marks the first time an mRNA-based cancer therapy has reached this stage of development with positive outcomes, paving the way for a potential regulatory approval application. The treatment is customized for each patient by analyzing tumor mutations to train the immune system to recognize and attack cancer cells, while Keytruda helps overcome cancer's immune evasion mechanisms. The trial focused on advanced melanoma patients who had undergone surgery, showing a statistically significant improvement in recurrence-free survival compared to Keytruda alone. This advancement is crucial as melanoma is an aggressive cancer with over 330,000 new cases globally in 2022. The successful Phase 3 results could lead to the first regulatory validation for personalized mRNA cancer treatment, potentially expanding its use to other tumor types. The announcement significantly impacted the stock market, with Moderna's shares increasing by over 2.5 times and Merck's by over 12%.