The Institute of Personalized Oncology of the IM Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation has launched the final stage of the clinical trial of the Russian drug pembrolizumab against advanced forms of melanoma. This is a biosimilar of the American drug, the development of which began as part of the import substitution of the original, socialbites.ca was told about this at Sechenov University.
The drug was developed by the R-Pharm group of companies. It is a bioanalogue of an American immuno-oncology drug, which is successfully used in the treatment of late stages of melanoma, small cell lung cancer and malignant neoplasms of female genital organs.
The first two stages also took place at Moscow State Medical University. Sechenov. The first two stages showed good results in terms of tolerability and safety of the drug, so the scientists moved on to the final stage, which was carried out before the drug was licensed.
The third stage should confirm the effectiveness of the product. 300 people will participate in the study. Participants in the study will be divided into two groups: The first will use the Russian product, the second will use the American product. The treatment period for melanoma patients is two years, but the first results on the effectiveness of the drug will be available within six months after the start of the study.
“The tumor has mechanisms that protect itself from the immune system. As a result, it does not recognize the tumor as an enemy to be fought. Immuno-oncology drugs restore immunity, which allows the immune system to recognize the tumor and destroy it. For melanoma, these drugs are effective in 30 percent of cases in the advanced stages of the disease.” Previously, the average life expectancy of such patients did not exceed six months, Marina Sekacheva, director of the Institute of Personalized Oncology at Sechenov University, told socialbites.ca.
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