Scientists at the Center for Mathematical Modeling in Drug Development at Sechenov University have established and registered the first database that catalogs side effects associated with checkpoint inhibitors and their combinations in immuno-oncology agents. These advanced medications have revolutionized cancer treatment. However, despite their efficacy in managing the disease, they can also cause side effects that must be taken into account. The database is intended to assist developers of new drugs in selecting optimal dosages during clinical trial planning, Izvestia writes.
Kirill Peskov, head of the Center for Mathematical Modeling in Drug Development at Sechenov University, stated, «We have set ourselves the task of creating a new tool for predicting the safety of immuno-oncological therapies as part of a digital platform. It will allow drug developers to find optimal solutions for the combinations of drugs, doses, and dosage regimens of each component».
Currently, several key groups of checkpoint inhibitors are available on both Russian and foreign markets. These include PD-1 inhibitors such as pembrolizumab and nivolumab, PD-L1 inhibitors like durvalumab and atezolizumab, and CTLA-4 inhibitors such as ipilimumab and tremelimumab. These drugs are used to treat melanoma, lung, kidney, and bladder cancer, and some other types of cancer. Treatment can be administered either as monotherapy or in combination with other immuno-oncological drugs or chemotherapy.
The use of these therapies may be accompanied by a range of side effects, including immune-mediated reactions, endocrine disorders, and gastrointestinal issues. Consequently, ongoing patient monitoring is critical, ensuring treatment safety and optimizing dosages, especially essential in drug development contexts.
The Russian scientists’ database organizes information on severe adverse reactions noted during clinical trials of immuno-oncology agents. It incorporates data on the frequency of side effects, treatment parameters—including dosage, regimen, and drug combinations—as well as relevant research characteristics such as cancer type, age, and gender of patients. This data analysis enables an assessment of therapy safety and optimization of treatment regimens.
The database is continually updated with new information regarding innovative checkpoint inhibitors and biosimilars emerging both in Russia and globally. The developers plan to integrate this technology into a digital platform for mathematical modeling of cancer, aimed at facilitating new drug development at Sechenov University.
Experts consulted by the publication assert that immuno-oncology agents represent a significant breakthrough in cancer treatment in recent decades. These drugs are increasingly included in protocols for the most severe cancer forms. Nevertheless, therapy sometimes needs to be halted due to side effects. The new database aims to minimize these unwanted reactions, particularly in outpatient settings, where continuous medical oversight may not be available, potentially increasing risks.
