Chicago: Moderna's personalised mRNA cancer vaccine, developed with Merck, reduced the risk of melanoma recurrence and cancer spread in a late-stage clinical trial when used alongside Merck's blockbuster immunotherapy Keytruda.Interim results from the ongoing Phase III study showed that the treatment, known as Intismeran, met both its primary goal of reducing cancer recurrence and its secondary objective of preventing the disease from spreading to other parts of the body, compared with Keytruda alone.The findings mark a major milestone for the biotechnology industry, representing the first positive late-stage trial result for an mRNA cancer vaccine and the first study to demonstrate that adding a treatment to Keytruda improves outcomes in patients whose melanoma has been removed through surgery.The results triggered a strong market reaction, with Moderna shares surging about 90% in premarket trading, while Merck shares rose 7.5%.The treatment combines Keytruda with a customised mRNA vaccine designed specifically for each patient based on genetic mutations identified in their tumour.The trial enrolled 1,137 high-risk patients with Stage IIB to Stage IV melanoma whose cancer had been surgically removed. Participants received either up to nine doses of Keytruda plus the personalised vaccine or Keytruda alone over approximately one year.The companies reported that no new safety concerns emerged during the study.The latest findings build on mid-stage trial results announced earlier this year, which showed the combination reduced the risk of recurrence or death by 49% after five years.Analysts said the results could significantly strengthen Moderna's long-term growth prospects as the company seeks to diversify beyond its COVID-19 business, while also helping Merck prepare for the eventual patent expiry of Keytruda later this decade.William Blair analyst Myles Minter said the data places both companies in a strong position to pursue regulatory approval and could have positive implications for ongoing studies evaluating the vaccine in other cancer types.Merck Research Laboratories President Dean Li said the companies expect to begin discussions with regulators in the coming months.Barclays analysts estimate the treatment could generate approximately $3 billion in annual melanoma sales by 2035.J.P. Morgan analysts said a successful launch of Intismeran in melanoma would be a key factor in helping Moderna return to profitability.Speaking on CNBC, Moderna Chief Executive Officer Stephane Bancel said pricing decisions have not yet been made.He noted that unlike certain personalised cell therapies, the vaccine does not rely on a patient's own cells, which could make large-scale manufacturing easier and potentially lower costs.Melanoma is the deadliest form of skin cancer. According to the US National Cancer Institute, more than 1.5 million people in the United States were living with melanoma in 2023.
