Merck and Moderna announced on Wednesday that a study involving a customized mRNA vaccine in combination with the immunotherapy drug Keytruda showed a decrease in skin cancer recurrence and spread compared to using Keytruda alone. This marks the first positive outcome in a late-stage trial for an mRNA cancer vaccine.
The trial, named Intismeran, is still ongoing, but interim results have demonstrated that the treatment has successfully achieved its primary objective of reducing cancer recurrence and its secondary goal of preventing cancer from spreading to other parts of the body.
Dr. Lennard Lee, a consultant medical oncologist and associate professor at Oxford, described the findings as significant. This trial represents the first positive Phase 3 trial combining immunotherapy and mRNA technology, a milestone in the medical field that researchers have been striving for over many years.
However, Dr. Lee pointed out that crucial information has yet to be disclosed, such as the extent of the Phase III benefit, detailed subgroup analyses, quality-of-life data, and mature overall-survival results. These details are essential for the scientific and clinical community to determine the treatment’s efficacy, the most responsive patient profiles, and its potential placement within standard melanoma care.
Both companies have confirmed that they will present their findings at an upcoming medical conference and share them with regulatory authorities.
In response to the results, Melanoma Canada CEO Falyn Katz expressed optimism about the personalized mRNA therapy’s potential to offer high-risk patients protection against melanoma recurrence or metastasis. Katz emphasized the importance of reviewing the full data to understand the implications of this innovative treatment for Canadian patients.
The treatment involves combining Merck’s Keytruda with a tailor-made mRNA vaccine from Moderna based on an analysis of mutations present in the patients’ tumor samples. Messenger-based RNA vaccines, popularized during the COVID-19 pandemic, provide instructions to our cells to help the immune system recognize and combat pathogens. In this case, tumor samples are utilized to identify abnormal proteins in cancer cells, known as neoantigens, enabling the mRNA vaccine to train the immune system to target and destroy cancer cells carrying these antigens.
The trial enrolled 1,137 high-risk patients with Stage 2B-4 melanoma who had undergone surgical removal of the cancer. Participants were randomly assigned to receive up to nine doses of Keytruda along with the personalized vaccine or Keytruda alone for approximately one year. The companies reported no new safety concerns during the trial.
Earlier in January, the companies released the results of a mid-stage trial indicating a 49% reduction in the risk of recurrence or death after five years with this treatment. Following this news, Moderna’s stock surged by more than 150%, while Merck’s shares increased by over 10%.
According to the Canadian Cancer Society, an estimated 11,300 Canadians are expected to be diagnosed with melanoma this year, with approximately 1,250 fatalities predicted. Melanoma Canada highlights that melanoma is prevalent among Canadians aged 15 to 49.
As of 2023, the U.S. National Cancer Institute reported that over 1.5 million individuals in the United States were living with melanoma.
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