CHICAGO, United States — Moderna’s personalized mRNA cancer therapy Intismeran has delivered positive results in a late-stage melanoma trial conducted with Merck, sending Moderna shares sharply higher on Wednesday. The treatment, when combined with Merck’s Keytruda, met its main goal of reducing cancer recurrence and also achieved a key secondary goal involving the prevention of cancer spread.
- Moderna shares surged around 150% following the interim trial results, while Merck gained 11% in early trading.
- The Phase 3 study enrolled 1,137 patients with surgically removed, high-risk stage IIB-IV melanoma.
- Intismeran met both the primary recurrence-free survival target and the secondary distant metastasis-free survival target.
- Merck and Moderna are already discussing the treatment with regulators, with Moderna saying it could potentially become available as soon as next year.
Moderna melanoma vaccine delivers positive Phase 3 results
The latest findings mark a major development for Moderna’s efforts to expand its mRNA technology beyond its COVID-19 vaccine. Intismeran is an individualized treatment designed using mutations identified in each patient’s tumor.
In the ongoing trial, patients whose melanoma had been surgically removed were randomly assigned to receive Keytruda alongside up to nine doses of the personalized vaccine or Keytruda alone for approximately one year.
The interim analysis showed that the combination achieved the trial’s primary objective of reducing cancer recurrence. It also met a secondary objective measuring the ability to prevent tumors from spreading to other parts of the body.
Moderna shares jump as investors react to trial success
Investors responded strongly to the results, with Moderna shares rising around 150% and trading at $160.25 in early activity. Merck shares climbed 11% as the companies’ collaboration produced a potentially important new treatment opportunity.
Moderna has faced pressure from investors over its ability to develop new commercial opportunities using its mRNA platform after the decline of its COVID-19 vaccine business. The melanoma results could provide a significant boost to that strategy.
For Merck, the development comes as the company prepares for the eventual loss of patent protection for Keytruda, its blockbuster cancer medicine. A successful combination therapy could therefore have strategic importance for both companies.
First positive late-stage result for an mRNA cancer vaccine
The companies described the result as an important milestone for personalized cancer treatment. According to the supplied Reuters report, it is the first positive late-stage trial result for an mRNA cancer vaccine and the first study of this type to show that adding another treatment to Keytruda produced better results than Keytruda alone in patients whose melanoma had been surgically removed.
“This is the first time that we’ve seen really clinically significant, statistically significant improvements over checkpoints like Keytruda in this population, and it is the first time we’ve done that with an individualized treatment,” Moderna President Stephen Hoge said.
William Blair analyst Myles Minter said the interim findings put both companies in a strong position as they pursue regulatory approval. He also said the results could have positive implications for ongoing studies examining the personalized vaccine in other cancers.
Moderna and Merck begin regulatory discussions
Merck said the companies have already begun discussions with regulators regarding the treatment. Hoge said the therapy’s breakthrough therapy designation could allow it to become available as soon as next year, although regulatory approval remains necessary.
The companies have not yet announced a price for Intismeran. Moderna CEO Stephane Bancel said the latest data had only become available a few days earlier and that pricing decisions had therefore not been finalized.
How the personalized melanoma treatment works
Intismeran combines Keytruda with a made-to-order mRNA vaccine developed by Moderna. The vaccine is designed using an analysis of mutations found in an individual patient’s tumor.
The Phase 3 study included 1,137 patients with high-risk stage IIB-IV melanoma that had already been surgically removed. Participants received treatment for roughly one year under the two study approaches.
The companies said no new safety signals had emerged in the trial. Earlier, in January, they reported five-year results from a mid-stage study showing that the combination reduced the risk of recurrence or death by 49%.
Potential commercial opportunity remains significant
Barclays analysts estimated last month that the therapy could generate approximately $3 billion in annual melanoma sales by 2035. J.P. Morgan analysts have also described the potential launch of Intismeran as an important factor in Moderna’s path back toward profitability.
Bancel said the treatment does not require patients’ own cells to manufacture the therapy, unlike some personalized cell-based treatments. That difference could potentially make production easier to scale and help reduce manufacturing costs, although the companies have not yet finalized pricing.
What happens next for Moderna’s cancer vaccine?
The immediate focus will be on the full trial results, regulatory discussions and the companies’ plans for a potential launch. The positive interim findings could also influence the development of Intismeran in other cancer types.
For Moderna, the results offer an important test of whether its mRNA technology can become a broader platform for medicines beyond COVID-19. For Merck, the treatment could complement Keytruda as the company faces the longer-term challenge posed by the drug’s expected patent expiry later this decade.
What is Intismeran?
Intismeran is Moderna’s personalized mRNA cancer therapy developed with Merck. It is designed using mutations identified in an individual patient’s tumor and is being studied in combination with Keytruda for melanoma.
How many patients were included in the melanoma trial?
The late-stage trial enrolled 1,137 patients with high-risk stage IIB-IV melanoma that had been surgically removed. Participants received either the Keytruda and personalized vaccine combination or Keytruda alone.
Financial Disclaimer: This article is for informational and news-reporting purposes only. It does not constitute investment advice, a recommendation to buy or sell securities, or a guarantee of future performance. Investors should conduct their own research and consult a qualified financial professional before making investment decisions.
Praveen Yadav is the Founder and Content Creator of The Nation Bulletin, an independent digital news platform focused on delivering timely, reliable and meaningful news from India and around the world.
