Moderna shares jumped over 110% in early trading on Wednesday after the drugmaker said its mRNA skin cancer vaccine, used alongside Merck’s immunotherapy Keytruda, achieved key goals in a late-stage trial involving patients with melanoma. The study is still ongoing, but interim results showed that the treatment, Intismeran, met its primary endpoint of reducing the risk of cancer recurrence.
It also achieved a secondary goal of lowering the risk of the cancer spreading to other parts of the body. The results provide a major boost to Moderna as the company seeks to diversify its business beyond its COVID-19 vaccine. Moderna has recently expanded its portfolio with an FDA-approved flu vaccine and is also developing experimental vaccines targeting diseases such as norovirus and Lyme disease.
Wall Street analysts had identified the cancer vaccine programme as a potentially important catalyst for Moderna. Positive results could help improve investor confidence in the company and strengthen the long-term outlook for its pipeline. Barclays analysts said last month that they estimate the treatment could generate roughly $3 billion in annual revenue from melanoma treatment by 2035.
Moderna shares were trading higher by 110%, or $69.23, at $132.19, while Merck stock gained 7.7%. The experimental treatment combines Keytruda with a personalised mRNA vaccine developed by Moderna. The vaccine is tailored to each patient using an analysis of mutations identified in the individual's tumour, with the aim of helping the immune system recognise and attack cancer cells more effectively.
The late-stage trial included 1,137 patients considered to have high-risk stage IIB to stage IV melanoma that had been surgically removed. Participants were randomly assigned to receive as many as nine doses of Keytruda along with the personalised vaccine, or Keytruda alone, over roughly one year.
Moderna and Merck said no new safety concerns have emerged from the study. The latest findings build on results announced in January from a mid-stage trial. At that time, the companies said the combination reduced the risk of cancer recurrence or death by 49% after five years.
Moderna and Merck said they plan to present the latest findings at an upcoming medical conference and submit the data to regulatory authorities. Melanoma is considered the deadliest form of skin cancer. More than 1.5 million people in the US were living with melanoma in 2023, according to the National Cancer Institute, underscoring the potential significance of new treatments that can prevent the disease from returning or spreading.