GDF-15 AS A HAEMATOLOGICAL TOXICITY BIOMARKER Russian patent published in 2021 - IPC A61K31/496 G01N33/50 G01N33/52 A61P35/00 

FIELD: medicine.

SUBSTANCE: group of inventions is intended to determine the toxic effect of the Mdm2 inhibitor in the individual suffering from cancer. Safety biomarker used to determine the toxic effect of the Mdm2 inhibitor is GDF-15. To determine the toxic effect of the Mdm2 inhibitor, the individual performs: (i) obtaining a biological sample taken from said individual prior to administering the Mdm2 inhibitor; (ii) determining the expression level of GDF-15 in the sample before administration; (iii) administering a dose of Mdm2 inhibitor to an individual; (iv) obtaining a biological sample taken from an individual after administering said Mdm2 inhibitor; (v) determining the expression level of GDF-15 in the sample after administration; and (vi) comparing the expression level of GDF-15 in a sample prior to administration with the expression level of GDF-15 in the sample after administration. If the expression level of GDF-15 increases by at least 25 % in said sample after administration compared to said sample before administration higher probability of patient developing thrombocytopenia in response to continuous administration of said dose of Mdm2 inhibitor. What is also presented is using the Mdm2 inhibitor in treating cancer in an individual, where either the therapeutic course of said individual is changed, if the expression level of GDF-15 in the sample after introduction is at least 25 % higher than the expression level of GDF-15 in the sample before administration; or a course of treating said individual with said Mdm2 inhibitor is unaffected if the expression level of GDF-15 in the sample after administration is less than 25 % higher than the expression level of GDF-15 in the sample before administration. Also provided are kits for predicting the probability of developing a patient suffering cancer, thrombocytopenia in response to treatment with a dose of the Mdm2 inhibitor, and for treating a patient suffering from cancer.

EFFECT: using the group of inventions enables predicting an increase in the patient's thrombocytopenia in response to administering the Mdm2 inhibitor, as well as adjusting the treatment regimen of a patient suffering from cancer.

38 cl, 4 ex, 8 dwg