Moderna and Merck have released promising results from late-stage research into the personalized mRNA vaccine intismeran. The treatment, combined with the immunotherapy Keytruda, was tested in high-risk patients diagnosed with melanoma, according to information from the Wall Street Journal.
More than a thousand individuals who had undergone surgery to remove a melanoma tumor participated in the study. The main objective was to reduce the chances of the cancer returning. The research achieved its primary goal, which was to extend the period without the disease reappearing, and also a secondary goal, preventing the tumor from spreading to other organs.
These are the first positive data obtained in a late-phase study for a personalized mRNA therapeutic approach to combat cancer. The achievement validates decades of scientific work dedicated to the development of customized treatments, aimed at the specific mutations of each type of tumor.
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How personalized vaccine fights cancer cells
Unlike conventional vaccines, which aim to prevent infections, intismeran works as a therapeutic vaccine. It is produced individually for each patient.
After surgical removal of the tumor, doctors collect blood and tumor tissue samples for detailed genetic analysis. Based on these exams, scientists are able to identify the exclusive mutations present in cancer cells, those that have a greater capacity to activate the patient’s immune system. These mutations are then encoded into mRNA molecules, which are used to manufacture the vaccine. The entire process, from biopsy to vaccine, takes approximately six weeks.
While the vaccine is being developed, patients undergo post-surgical recovery and begin treatment with Keytruda, a medication that helps control the disease during this phase.
Previous data and what is still awaited about the treatment
Preliminary studies had already indicated that the combination of the vaccine with Keytruda resulted in a 49% reduction in the risk of recurrence or death from melanoma, when compared to the use of Keytruda alone.
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The new research data, however, still does not detail the exact time that patients remained without disease progression, nor the average survival achieved. Moderna and Merck plan to present more complete information at a medical conference later this year. The drug is expected to be available on the market in 2027.
Impact of the discovery for pharmaceutical giants
For Moderna, the results open a vast new field in the oncology drug market, estimated at more than US$240 billion. The company has faced a reduction in sales of its vaccine against Covid-19 and this advance represents a new frontier.
“We are now an oncology company,” said Stéphane Bancel, CEO of Moderna.
For Merck, the new treatment could be essential to offset the imminent loss of the patent for Keytruda, one of the best-selling drugs globally.
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The announcements had an immediate impact on the stock market: Moderna’s shares rose more than 60% in the day’s trading, while Merck’s rose 7.3%.
Challenges to be overcome in accessing treatment
The production of personalized cancer vaccines is recognized as a complex and high-cost process. Given this, crucial questions about the accessibility of the treatment and its final price remain open, should approval be granted.
To date, the only therapeutic cancer vaccine approved by the Food and Drug Administration (FDA) is Provenge, a personalized immunotherapy developed to combat prostate cancer. Meanwhile, intismeran is already being studied for other types of cancer, including bladder, lung and kidney cancer.