Moderna (MRNA.O) and Merck (MRK.N) announced that their personalized mRNA cancer vaccine significantly reduced the risk of recurrence and spread of melanoma in a late-stage trial. This major success in cancer treatment caused Moderna's shares to surge by as much as 160% on Wednesday. The vaccine was tested in combination with Merck's immunotherapy drug Keytruda, which is already a widely used melanoma treatment.
Thousands of patients who have undergone surgery to remove high-risk melanoma tumors could benefit from this new therapy as early as next year, pending regulatory approval, according to Moderna President Stephen Hoge. This marks the first positive outcome in a late-stage trial for a personalized mRNA cancer vaccine. Merck's shares also jumped over 12% following the announcement.
The combination regimen met its primary goal by significantly extending the time patients lived without their melanoma returning, compared to Keytruda alone. It also reduced the risk of the cancer spreading to distant parts of the body. These positive results build on earlier Phase 2 trial data for the same regimen. Barclays estimates that the therapy could generate approximately $3 billion in melanoma sales by 2035.
Moderna CEO Stéphane Bancel described the results as a "landmark moment for adjuvant melanoma treatment" and highlighted the potential of a new class of medicine that uses information from a patient's cancer to train their immune system. While the Phase 3 study continues to assess other outcomes like overall survival, the initial data suggests this combination could become a new treatment option for melanoma, a type of skin cancer responsible for most skin cancer deaths, despite accounting for only about 1% of cases.