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Tengrinews.kz — In mid-August, two major American pharmaceutical and biotech companies reported successful trial results for a new skin cancer vaccine. According to their data, the vaccine helped reduce the risk of tumor recurrence in patients following surgery. Tengrinews correspondent explored the significance of this result for global oncology and whether such therapy could become available in Kazakhstan.
The companies issued the successful completion of Phase 3 trials for intismeran autogene, a personalized mRNA vaccine for the treatment of melanoma (skin cancer).
The study involved more than a thousand patients who had previously undergone tumor removal but remained at high risk of recurrence.
Participants were divided into two groups: one received only an anti-tumor drug, while the other received the same drug in combination with the personalized vaccine. Treatment lasted approximately one year.
The results showed that the new vaccine worked more effectively when combined with the drug. According to the companies, this combination helped reduce the risk of the disease returning or spreading.
This is a landmark event for medicine and oncology, as it marks the first time such an approach has demonstrated efficacy in a large-scale Phase 3 study. The drug has passed its most critical test prior to potential market entry.
However, it is still too early to label it a "cancer vaccine"—the full study results are yet to be thoroughly reviewed.
Oksana Shatkovskaya, Deputy Chairwoman of the Board of the National Scientific Cancer Center, whom we contacted for comment, explained how this approach differs from vaccinations such as the one against human papillomavirus (HPV).
"The HPV vaccine is preventive. It is administered to a healthy person. Put simply, it teaches the immune system to fight a virus that can cause cancer, whereas personalized mRNA therapy helps the immune system recognize cancer cells that have already emerged," the specialists noted.
Thus, unlike conventional vaccines that prevent infectious diseases, the therapeutic personalized anti-tumor vaccine is administered to patients at high risk of recurrence after surgical tumor removal.
Shatkovskaya explains that personalized cancer vaccines also differ from other treatment methods.
Standard chemotherapy, widely used in oncology, affects both cancer cells and healthy cells.
Immunotherapy, by contrast, activates the body's defense system to fight cancer. A personalized vaccine is designed to train the immune system to specifically attack mutations found in an individual patient's tumor.
Oksana Shatkovskaya considers the study results significant for modern oncology but urges caution until a full analysis is completed.
"This is the first time personalized mRNA neoantigen therapy has demonstrated a positive result in a large Phase 3 study. If the full results confirm the claimed effect and the therapy receives regulatory approval, it could open a new frontier in treating not only melanoma but potentially other tumors as well," the doctor says.
At the same time, the specialist emphasizes that this is not the first attempt to create a therapeutic cancer vaccine. Such approaches have been studied for a long time, but this is the first time developers have reached this level of clinical research.
According to Oksana Shatkovskaya, modern oncology is gradually moving away from the "one drug for all patients with the same diagnosis" concept toward increasingly personalized treatment.
"That is why we in Kazakhstan are also closely following such research," the speaker noted.
The National Scientific Cancer Center noted that if the vaccine is registered and included first in international and then in national clinical guidelines, it could be used in the future as a way to reduce the risk of cancer recurrence after surgery.
However, implementing a new type of treatment requires more than "just buying the drug"— it necessitates a specialized medical infrastructure that allows for the application of these technologies.
Doctors must obtain a sample of the patient's tumor, analyze it at a molecular genetic level to identify its specific characteristics, and use this data to create a personalized medication before administering advanced immunotherapy.
"Currently, Kazakhstan faces a much broader challenge: the development of molecular diagnostics and genomic tumor profiling—where cancer cell DNA is studied to find more effective treatments—as well as bioinformatics for analyzing large volumes of genetic data, and the participation of our centers in international clinical trials," says Oksana Shatkovskaya.
The National Scientific Oncology Center in Astana is already advancing this field. A modern reference center for molecular genetic research is currently being established there. One of its primary objectives is to develop a personalized approach to cancer diagnosis and treatment in Kazakhstan.
We previously reported that a Kazakhstani cancer drug could be released as early as 2027. The drug is currently undergoing phase two clinical trials on patients, after which it will move to registration. This was announced by the Minister of Science and Higher Education, Sayasat Nurbek.