Moderna and Merck announced positive results from a late-stage trial for their personalized mRNA cancer vaccine, mRNA-4157 (also known as intismeran), when combined with Merck’s immunotherapy Keytruda. The combination significantly reduced the risk of melanoma returning or spreading in patients who had undergone surgery to remove high-risk tumors. This marks a major success in the emerging field of mRNA cancer vaccines.
The announcement led to a dramatic increase in the stock prices of both companies. Moderna's shares surged by as much as 177% on Wednesday, reflecting its market capitalization of around $25 billion before the news. Merck's stock also climbed by more than 12%, given its larger market capitalization of approximately $333 billion. Analysts are optimistic, with Barclays estimating the therapy could generate around $3 billion in melanoma sales by 2035.
This Phase 3 trial, involving over 1,100 patients, met its primary endpoint 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. The results build upon positive Phase 2 data from earlier this year. The companies plan to present detailed data at an upcoming international medical meeting and will begin discussions with regulatory agencies for approval in the coming months.
Moderna President Stephen Hoge indicated that thousands of patients who have undergone surgery for high-risk melanoma could benefit as early as next year if regulatory approval is secured. This outcome is considered a "landmark moment" by analysts and a "big moment for medicine, a big moment for patients" by Moderna CEO Stephane Bancel. The study is ongoing to assess other outcomes, including overall survival benefit.
Jefferies analyst Andrew Tsai projected billions of dollars in sales from the vaccine in melanoma alone. The companies are also exploring the treatment's efficacy against other cancers, including lung, kidney, and bladder cancer. The successful trial represents a significant advancement for personalized cancer treatment using mRNA technology.
