According to an article published in Barron’s, Stéphane Bancel, MBA, Chief Executive Officer of Moderna, announced that the company’s experimental melanoma vaccine mRNA-4157 may be launched under accelerated approval by 2025. In 2020, there were over 325,000 new cases of melanoma diagnosed across the world, and 57,000 patients died from the disease. Experts explained that the novel mRNA-4157 vaccine works by utilizing messenger RNA technology to train the immune system to target melanoma cells; it was designed to treat rather than prevent cancer. A recent clinical trial demonstrated positive survival outcomes among 157 patients with advanced melanoma who received the vaccine. In the trial, the patients were assigned to receive either the mRNA-4157 vaccine in combination with pembrolizumab or pembrolizumab alone. After a follow-up of 3 years, those who received the combination had a 49% reduced risk of cancer recurrence or mortality compared with those who received pembrolizumab monotherapy. In 2022, Moderna reported a 44% risk reduction after a follow-up of 2 years—representing an increase in survival without additional side effects. The U.S. Food and Drug Administration and the European Medicines Agency have both already placed the mRNA-4157 vaccine on an expedited review path. A new phase II trial involving 1,000 patients may secure earlier conditional authorization in 2024.


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