BCD-100 - first russian PD-1 inhibitor
Purpose. To evaluate pharmacokinetics, pharmacodynamics, safety, immunogenicity and efficacy of intravenous infusions of BCD-100 (JSC “BIOCAD”, Russia) in increasing doses. Patients (materials) and methods. Patients with advanced malignant tumors of various localizations without severe somatic patho...
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IP Habib O.N.
2017-09-01
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Online Access: | https://modernonco.orscience.ru/1815-1434/article/viewFile/27133/pdf |
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doaj-6751069bb31a44e7bf9f32138fa3a1cd2020-11-25T02:53:02ZrusIP Habib O.N.Современная онкология1815-14341815-14422017-09-0119351224353BCD-100 - first russian PD-1 inhibitorS A Tyulyandin0M Yu Fedyanin1T Yu Semiglazova2V M Moiseenko3S V Odintsova4B Ya Alekseev5R A Ivanov6M S Shustova7N.N.Blokhin National Medical Cancer Research Center of the Ministry of Health of the Russian FederationN.N.Blokhin National Medical Cancer Research Center of the Ministry of Health of the Russian FederationN.N.Petrov National Medical Cancer Research Center of the Ministry of Health of the Russian FederationSaint Petersburg Clinical Research and Practical Center for Specialized (oncological) CareLimited Liability Company “BioEq”National Medical Research Radiological Center of the Ministry of Health of the Russian FederationJoint-Stock Company “BIOCAD”Joint-Stock Company “BIOCAD”Purpose. To evaluate pharmacokinetics, pharmacodynamics, safety, immunogenicity and efficacy of intravenous infusions of BCD-100 (JSC “BIOCAD”, Russia) in increasing doses. Patients (materials) and methods. Patients with advanced malignant tumors of various localizations without severe somatic pathology were consistently included in cohorts receiving the BCD-100 drug in monotherapy at different doses (0.3, 1.0, 3.0 and 10 mg/kg) every 2 weeks for at least 85 days. Safety, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of the therapy were assessed. Results. 15 patients were included in the study. The vast majority of adverse events were represented by deviations in the results of laboratory tests of 1-2 grade, there was only one confirmed case of dose-limiting toxicity (autoimmune thyroiditis of 2 grade). Pharmaco kinetic parameters were standard for drug based on monoclonal antibodies of class IgG1. The saturation of PD-1 receptors by BCD-100 was high (90-100%) at all dose levels. 1 partial response to antitumor therapy and 3 stabilization cases according to irRC criteria were registered. conclusion. BCD-100 demonstrated a favorable profile of safety and immunogenicity, expected pharmacokinetic parameters allowing the drug to be administered once every 2 or 3 weeks, high pharmacodynamic parameters and the presence of antitumor activity.https://modernonco.orscience.ru/1815-1434/article/viewFile/27133/pdfbcd-100pd-1oncological diseasesimmunotherapybcd-100pd-1monoclonal antibodypharmacokineticspharmacodynamicssafetyefficacyimmunogenicitydose-limiting toxicity |
collection |
DOAJ |
language |
Russian |
format |
Article |
sources |
DOAJ |
author |
S A Tyulyandin M Yu Fedyanin T Yu Semiglazova V M Moiseenko S V Odintsova B Ya Alekseev R A Ivanov M S Shustova |
spellingShingle |
S A Tyulyandin M Yu Fedyanin T Yu Semiglazova V M Moiseenko S V Odintsova B Ya Alekseev R A Ivanov M S Shustova BCD-100 - first russian PD-1 inhibitor Современная онкология bcd-100 pd-1 oncological diseases immunotherapy bcd-100 pd-1 monoclonal antibody pharmacokinetics pharmacodynamics safety efficacy immunogenicity dose-limiting toxicity |
author_facet |
S A Tyulyandin M Yu Fedyanin T Yu Semiglazova V M Moiseenko S V Odintsova B Ya Alekseev R A Ivanov M S Shustova |
author_sort |
S A Tyulyandin |
title |
BCD-100 - first russian PD-1 inhibitor |
title_short |
BCD-100 - first russian PD-1 inhibitor |
title_full |
BCD-100 - first russian PD-1 inhibitor |
title_fullStr |
BCD-100 - first russian PD-1 inhibitor |
title_full_unstemmed |
BCD-100 - first russian PD-1 inhibitor |
title_sort |
bcd-100 - first russian pd-1 inhibitor |
publisher |
IP Habib O.N. |
series |
Современная онкология |
issn |
1815-1434 1815-1442 |
publishDate |
2017-09-01 |
description |
Purpose. To evaluate pharmacokinetics, pharmacodynamics, safety, immunogenicity and efficacy of intravenous infusions of BCD-100 (JSC “BIOCAD”, Russia) in increasing doses. Patients (materials) and methods. Patients with advanced malignant tumors of various localizations without severe somatic pathology were consistently included in cohorts receiving the BCD-100 drug in monotherapy at different doses (0.3, 1.0, 3.0 and 10 mg/kg) every 2 weeks for at least 85 days. Safety, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of the therapy were assessed. Results. 15 patients were included in the study. The vast majority of adverse events were represented by deviations in the results of laboratory tests of 1-2 grade, there was only one confirmed case of dose-limiting toxicity (autoimmune thyroiditis of 2 grade). Pharmaco kinetic parameters were standard for drug based on monoclonal antibodies of class IgG1. The saturation of PD-1 receptors by BCD-100 was high (90-100%) at all dose levels. 1 partial response to antitumor therapy and 3 stabilization cases according to irRC criteria were registered. conclusion. BCD-100 demonstrated a favorable profile of safety and immunogenicity, expected pharmacokinetic parameters allowing the drug to be administered once every 2 or 3 weeks, high pharmacodynamic parameters and the presence of antitumor activity. |
topic |
bcd-100 pd-1 oncological diseases immunotherapy bcd-100 pd-1 monoclonal antibody pharmacokinetics pharmacodynamics safety efficacy immunogenicity dose-limiting toxicity |
url |
https://modernonco.orscience.ru/1815-1434/article/viewFile/27133/pdf |
work_keys_str_mv |
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