clinical research

Background: BCD-021 is a bevacizumab biosimilar which was shown to be equivalent to reference bevacizumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to compare efcacy and safety of BCD-021 and reference bevacizumab in combination with paclitaxel and carboplatin in a frst-line treatment of inoperable or advanced non-squamous non-smallcell lung cancer (NSCLC). Methods: Patients with no previous treatment for advanced non-squamous NSCLC were randomly assigned 3:2 to BCD-021 or reference bevacizumab and were treated with bevacizumab + paclitaxel + carboplatin. Therapy continued for 6 cycles (every 3 weeks), until progression of the disease or unbearable toxicity. The primary study endpoint was the overall response rate. The study goal was to prove the equivalent efcacy of BCD-021 and reference bevacizumab. Equivalence margins for 95% CI for the diference in the overall respmore...

Prolgolimab is an IgG1 anti–PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing ‘LALA’ mutation. We assessed the efficacy and safety of two dosing regimens of prolgolimab in patients with advanced melanoma in a multicenter open-label parallel-arm phase II trial (MIRACULUM). We present the final analysis after 1 year of follow-up and additional efficacy results from 2 years of follow-up.

BCD-022 is a trastuzumab biosimilar which was shown to be equivalent to reference trastuzumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to comparatively assess efficacy and safety of BCD-022 and reference trastuzumab in combination with paclitaxel used as the therapy of metastatic HER2(+) breast cancer. Pharmacokinetics and immunogenicity were also studied.

BCD-020 is a proposed rituximab biosimilar, which has shown high similarity to rituximab in quality and nonclinical studies in vitro and in vivo. International multicenter clinical trial was conducted to compare efficacy and safety of BCD-020 and reference rituximab in adult (older than 18 years) patients with indolent lymphomas (follicular lymphoma grade 1-2, splenic marginal zone lymphoma, and nodal marginal zone lymphoma). Pharmacokinetics, pharmacodynamics, and immunogenicity were also studied. Patients with no previous biologic treatment for lymphoma were randomly assigned 1:1 to receive BCD-020 or comparator 375 mg/m2 for 4 weeks. Primary study outcome was day 50 overall response rate defined as complete or partial remission. Equivalence range was −20% to 20% for 95% CI for overall response rates difference. Secondary outcomes included adverse events, pharmacokinetics, pharmacodynamics, and immunogenicity. One hundred seventy-four patients were enrolled, 89 in BCD-020 arm and 85 more...

OBJECTIVES: Netakimab (NTK) is a humanised monoclonal antibody targeting interleukin-17A, previously investigated in a phase 1 trial in healthy volunteers. Here, we report the results of a phase 2 trial, conducted to assess safety and pharmacokinetics (PK), to establish a therapeutic dose of NTK in a target population of patients with active ankylosing spondylitis (AS). METHODS: 89 patients with active AS, despite non-steroidal anti-inflammatory (NSAID) drug treatment, were randomised to receive 40, 80 or 120 mg of subcutaneous NTK or placebo at weeks 0, 1, 2 and q2wk thereafter until week 12. The primary endpoint was to achieve a proportion of patients with ≥20% improvement in Assessment of Spondyloarthritis. RESULTS: Rates of ASAS20 response at week 16 for NTK with 95%CI for difference in ASAS20 rates NTK vs. placebo were 72.73% [1.69%;58.05%], 81.82% [12.36%;65.56%], 90.91% [23.71%;72.39%] at doses of 40, 80 and 120 mg. The response rate in the placebo arm was 42.86%. The pre-specifmore...

This review focuses on the structure and molecular action mechanisms of chimeric antigen receptors (CARs) and major aspects of the manufacturing and clinical application of products for the CAR-T (CAR-modified T lymphocyte) therapy of hematological and solid tumors with special emphasis on the strategies for combined use of CAR-T therapy with immuno-oncological monoclonal antibodies (checkpoint inhibitors) and cytokines to boost survival, persistence, and antitumor efficacy of CAR-T therapy. The review also summarizes preclinical and clinical data on the additive effects of the combined use of CAR-T therapy with interleukins and monoclonal antibodies targeting immune checkpoints.

Objective. To seek evidence that Timexon (BCD-063, glatiramer acetate, Biocad, Russia) and Copaxone-Teva (Teva Pharmaceuticals Ltd., Israel) have similar efficacies in patients with remitting multiple sclerosis. Materials and methods. A multicenter, double-blind, placebo-controlled, comparative, randomized, phase III study included 158 patients with confirmed diagnoses of remitting multiple sclerosis. Patients were randomized to the BCD-063, Copaxone-Teva, and placebo groups at a ratio of 2:2:1.

Objectives. To demonstrate equivalence of the efficacies of the drugs Teberif (BCD-033, interferon β-1a) and Rebif (interferon β-1a) in patients with remitting multiple sclerosis (RMS). Materials and methods. A multicenter, double-blind, placebo-controlled, comparative, randomized phase III trial included 163 patients with diagnoses of MS. Patients were randomized to the Teberif, Rebif, and placebo groups at a ratio of 1:1:1.

Background: Approval of the first monoclonal antibody against CD20-antigen, rituximab, heralded the new era of targeted therapy in hematology. Today there are many companies all over the world which have rituximab biosimilar at different stages of development. BIORIX is among the first clinical studies to demonstrate clinical comparability of rituximab biosimilar to innovator rituximab in patients with indolent non-Hodgkin's lymphoma. Aims: Evaluation of pharmacokinetics, pharmacodynamics, safety and efficacy of BCD-020 (rituximab biosimilar, BIOCAD, Russia) used as monotherapy in patients with indolent B-cell non-Hodgkin's lymphoma in comparison with the parameters of innovator rituximab (RTX). Methods: 92 patients (aged 18 years and older with diagnosed CD20-positive follicular non-Hodgkin's lymphoma, stage II-IV by Ann Arbor, 1-2 histologic grade, or marginal zone lymphoma) were enrolled into the study. Patients were randomised in 1:1 ratio to receive 375 mg/sq.m of BCD-020 or RTX omore...