October 27, 2026, 12:50 pm | Read time: 6 minutes
A cancer vaccine tailored for an individual patient: What initially sounds almost futuristic could change the treatment of melanoma in the future. Moderna and MSD Sharp & Dohme have presented new study data on their personalized mRNA cancer vaccine, Intismeran.
The therapy was studied in patients with melanoma whose tumors had been completely surgically removed. Participants received either the existing cancer treatment Keytruda alone or in addition to the individually manufactured cancer vaccine Intismeran. “The results have the potential to fundamentally change the treatment of early-stage melanoma,” said study leader Prof. Georgina Long.
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What Makes the Cancer Vaccine Special?
Unlike a traditional vaccine, not all patients receive the same preparation. Intismeran is instead tailored to the specific tumor. Researchers examine the cancer cells and look for unique characteristics of the tumor. From this information, they create a personalized mRNA vaccine. Simply put, the mRNA contains a kind of blueprint for the cells. The vaccine is intended to show the immune system up to 34 characteristic features of the tumor, helping the body’s defenses learn to better recognize and attack cancer cells.
“The vaccine is injected under the skin so that the proteins at the injection site are produced by the body and trigger or enhance an appropriate immune response,” explains oncologist Prof. Christof von Kalle.
Each Vaccine Is Tailored to the Specific Tumor
Prof. Dr. med. Katharina C. Kähler, senior physician and head of the Skin Cancer Center at the University Hospital Schleswig-Holstein (UKSH) at the Kiel campus, explains the process: “You have a person with a metastasis, which is removed, and the tissue is examined to determine what makes this tumor unique.”
The tissue is examined for so-called neo-antigens, which are characteristics of cancer cells that allow the immune system to recognize the tumor as foreign. The vaccine is then produced to match this individual cancer profile. “The downside is that it’s more complex and expensive–the truly new and great aspect is the individual tailoring to the person,” says Kähler.
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What Do the New Study Data Show?
The Phase 3 study involved 1,137 skin cancer patients whose tumors had been completely removed. They received either Keytruda alone or Keytruda plus the personalized cancer vaccine (FITBOOK already reported on the Phase 2 study of the vaccine in 2022).1 After two years, a significant difference was observed: Of 100 patients who received the additional cancer vaccine, about 82 were still alive and without recurrence of the disease. With Keytruda alone, it was 70 out of 100 patients.
The Study Phases
Phase 1 and Phase 2 studies are the first two important steps in which researchers test a new drug or medical procedure on humans for the first time. A Phase 3 study is a large-scale clinical trial of a new drug or therapy involving several hundred to several thousand patients (depending on the disease). It is the last major step before a pharmaceutical company can apply for official approval of the drug from authorities (such as the EMA in Europe or the FDA in the U.S.).
The risk of relapse or death was 42 percent lower with the combination therapy compared to treatment with Keytruda alone. The risk of cancer spreading or death was reduced by 38 percent. “This study provides the first evidence that a personalized mRNA cancer vaccine combined with immunotherapy can significantly reduce the risk of relapse in melanoma,” explains Prof. Dr. Christoffer Gebhardt, co-author of the study and head of the Skin Tumor Center at the University Hospital Hamburg-Eppendorf (UKE).
What Do the 42 Percent Really Mean?
Proper interpretation is crucial for such percentage figures. A 42 percent risk reduction does not mean that 42 percent fewer patients died. “Forty-two percent is the value that indicates how much the risk of cancer returning or dying from it is reduced–compared to the already approved standard treatment,” explains Kähler. “This is a good result.” It is a relative risk reduction compared to the comparison group.
What Side Effects Occurred?
The personalized cancer vaccine is not without side effects. The most common were:
- Fever: 52.2 percent
- Pain at the injection site: 51 percent
- Fatigue: 38.5 percent
Severe side effects occurred slightly more frequently with the combination with Intismeran at 14.2 percent than with treatment with Keytruda alone at 13.4 percent. According to Moderna and MSD, no new safety issues were identified.
Could the Principle Work for Other Types of Cancer?
This is one of the most exciting questions about the new therapy. Prof. Michael von Bergwelt from LMU Munich explained: “Because the vaccine is tailored to the genetic characteristics of a tumor, the principle can theoretically be applied to other types of cancer.”
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Prof. Christof von Kalle from the Berlin Institute of Health (BIH) at Charité Berlin also sees potential: “Immune responses to tumor characteristics are known in a number of cancers, such as lung cancer, kidney cancer, bladder cancer, certain forms of colon cancer, and others. It could well be that a similar vaccine could be successful in a number of these diseases.”
Kähler is somewhat more cautious: “We don’t know exactly yet. The opportunity lies in the ability to tailor the vaccine to the individual tumor.”
Among other things, it is crucial whether the respective tumor has characteristics that can be recognized as foreign by the immune system and thus specifically attacked. According to Moderna and MSD, nine studies are currently underway on various types of cancer, including lung, bladder, and kidney cancer.
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When Could the Cancer Vaccine Be Available in Germany?
The therapy is not yet approved. Moderna and MSD are already in discussions with the relevant authorities. For use in Germany, the therapy must first go through the approval process.
The cancer vaccine is part of a program by the European Medicines Agency (EMA) for particularly promising drugs, aimed at accelerating development. For those with statutory insurance, this currently means: The treatment is not yet routinely covered by health insurance. Joining the ongoing study is also no longer possible. It is listed as “active, not recruiting,” meaning it continues but is not accepting new participants.
Cancer Vaccine Is Not Yet a Miracle Cure
As promising as the results are, there is still no talk of a general “cancer vaccine.” Intismeran was studied in the present study with a specific group of melanoma patients and combined with an existing immunotherapy. This could make the procedure an important component in cancer treatment in the future. Whether the results hold up in the long term and for which other types of cancer such a personalized vaccine works will require further investigation.