A5014416915- Biosimilars and Bioanalytical Methods
- Monoclonal and Polyclonal Antibodies Research
- HER2/EGFR in Cancer Research
- Cancer Treatment and Pharmacology
- Complement system in diseases
- Lymphoma Diagnosis and Treatment
- Radiopharmaceutical Chemistry and Applications
- Pharmaceutical studies and practices
- Statistical Methods in Clinical Trials
- Colorectal Cancer Treatments and Studies
- Blood groups and transfusion
- CAR-T cell therapy research
- Health Systems, Economic Evaluations, Quality of Life
- Peptidase Inhibition and Analysis
- Cancer Genomics and Diagnostics
- Cancer Immunotherapy and Biomarkers
- Platelet Disorders and Treatments
- Pancreatic and Hepatic Oncology Research
- Erythropoietin and Anemia Treatment
- Protein purification and stability
- Breast Cancer Treatment Studies
- GDF15 and Related Biomarkers
- Neutropenia and Cancer Infections
- Safe Handling of Antineoplastic Drugs
- Health and Medical Research Impacts
Amgen (United States)
2016-2024
NGM Biopharmaceuticals (United States)
2022-2024
Marienhospital Bottrop
2018-2019
Oncology Institute of Vojvodina
2018-2019
Medica (Italy)
2019
German Breast group
2018
Spitalul Clinic Județean de Urgență Cluj-Napoca
2018
Abstract Purpose: This phase III study compared clinical efficacy and safety of the biosimilar ABP 215 with bevacizumab reference product (RP) in patients advanced nonsquamous non–small cell lung cancer (NSCLC). Patients Methods: were randomized 1:1 to or 15 mg/kg every three weeks for 6 cycles. All received carboplatin paclitaxel ≥4 ≤6 The primary endpoint was risk ratio objective response rate (ORR); equivalence confirmed if 2-sided 90% confidence interval (CI) within margin 0.67 1.5....
This study compared the pharmacokinetic (PK) profiles of proposed biosimilar ABP 980 and trastuzumab in healthy males. In this single-blind study, 157 males were randomized 1:1:1 to a single 6 mg/kg intravenous infusion 980, FDA-licensed [trastuzumab (US)], or EU-authorized (EU)]. Primary endpoints area under serum concentration–time curve from time 0 infinity (AUCinf) maximum observed concentration (C max). To establish equivalence, geometric mean ratio (GMR) 90% confidence interval (CI)...
This study compared the pharmacokinetic (PK) profiles of proposed biosimilar ABP 215 with bevacizumab in healthy males. In this randomized, single-blind, single-dose, three-arm, parallel-group study, subjects were randomized to receive (n = 68), (US) 67), or (EU) 67) 3 mg/kg intravenously. Primary endpoints area under serum concentration–time curve from time 0 extrapolated infinity (AUCinf) and maximum observed concentration (C max). Secondary included safety immunogenicity. AUCinf C max...
ABP 959 is a proposed biosimilar to eculizumab, monoclonal antibody targeting the human C5 complement protein. The objective of this randomized, double-blind, three-arm, study was demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity relative eculizumab reference product (RP) in healthy adult male subjects.Eligible subjects aged 18-45 years were randomized receive 300-mg IV infusion 959, or FDA-licensed (eculizumab US), EU-authorized EU). Primary PK endpoint area under total...
Analytic, pharmacokinetic (PK), and clinical similarity between the biosimilar ABP 215 bevacizumab has previously been demonstrated in global studies. Here we present a phase 1 study healthy adult Japanese men. This was randomized, single-blind, single-dose, parallel-group comparing PK parameters of versus EU-authorized Primary endpoints were maximum observed serum concentration (Cmax) area under concentration—time curve from time 0 to infinity (AUCinf). Secondary included AUC last...
ABP 798 is being developed as a biosimilar to rituximab reference product (RP), CD20-directed cytolytic antibody that approved in the US and EU for treatment of non-Hodgkin lymphoma (NHL). This randomized, double-blind, comparative clinical study (JASMINE) evaluated efficacy safety compared with RP. Adult, anti-CD20 naïve patients diagnosed grade 1, 2, or 3a follicular B-cell NHL expressing CD20 were randomized 1:1 receive 375 mg/m2 infusion either RP once weekly 4 weeks at 12 20. Tumor...
9095 Background: ABP 215 is a biosimilar candidate highly similar to BEV, VEGF inhibitor, in analytical and functional comparisons. Pharmacokinetic similarity between BEV has been demonstrated phase 1 study. Here we present primary efficacy safety results from 3 study non-small cell lung cancer (NSCLC). Methods: In this double-blind, active-controlled trial, subjects with non-squamous NSCLC on first-line chemotherapy carboplatin paclitaxel were randomized (1:1) or (15 mg/kg IV infusion Q3W...
Although the human epidermal growth factor receptor 2 (HER2) blocker trastuzumab is generally well tolerated, cardiotoxicity can be an important therapeutic limitation. In this prespecified analysis, we compared cardiac safety of biosimilar ABP 980 (KANJINTI™) and reference product (RP; Herceptin®) in phase III LILAC study (ClinicalTrials.gov identifier NCT01901146). neoadjuvant LILAC, after run-in chemotherapy, 725 patients were randomized 1:1 to (n = 364) or RP 361) plus paclitaxel (every...
ABP 959 is a biosimilar to the eculizumab reference product (RP), which approved for treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). This multicenter, randomized, double-blind, active-controlled, two-period crossover study randomized RP-treated PNH one two sequences (ABP 959/eculizumab RP or RP/ABP 959) evaluate clinical similarity when compared RP. evaluated efficacy based on control intravascular hemolysis as measured by lactate dehydrogenase (LDH) and time-adjusted...
Trastuzumab, a key treatment for HER2-positive breast cancer, is available in weight-based IV and fixed-dose (600 mg) SC formulations. While the Phase 3 HannaH trial indicated non-inferiority of formulation, there some concern that target plasma concentration may not be reached overweight/obese patients whereas low-body-weight at risk toxicity. This scoping review evaluated whether are below-target exposure with trastuzumab, increased toxicity, especially cardiotoxicity, trastuzumab...
Abstract Background: ABP 980 is being developed as a biosimilar to trastuzumab, monoclonal antibody (mAb) that binds human epidermal growth factor receptor 2 (HER2), resulting in proliferation inhibition (PI) and induction of antibody-dependent cell-mediated cytotoxicity (ADCC). Biosimilar mAbs are likely have minor differences with the reference product due variances expression systems, bioprocess, purification; demonstration analytical, pharmacologic, pharmacokinetic (PK) similarity...
ABP 215 (MVASI™, Amgen, Thousand Oaks, CA; MVASI™, Amgen Europe B.V., Netherlands) is a biosimilar to bevacizumab (Avastin®, Genentech, South San Francisco, CA) reference product (RP), monoclonal antibody targeting vascular endothelial growth factor A (VEGF-A). Here we provide brief overview of the totality evidence that supported approval 215, along with practical considerations ensure safe and effective administration. has been shown be highly similar RP, mechanism action, analytical...
Abstract Background: Analytical, functional, and pharmacokinetic similarity between ABP 980 trastuzumab (TRAS) has been demonstrated. Here we report results from the single switch treatment arm in adjuvant phase of corresponding clinical study. Methods: The objective this randomized, multicenter, double-blind study was to compare with TRAS women HER2-positive early breast cancer. After run-in anthracycline-based chemotherapy, patients were randomized 1:1 intravenous or plus paclitaxel Q3W...
ABP 980 (KANJINTI™, Amgen, Thousand Oaks, CA, USA; Amgen Europe B.V., The Netherlands) is a biosimilar to trastuzumab (Herceptin®), monoclonal antibody that selectively binds human epidermal growth factor receptor-2 (HER2). Here we provide brief overview of the totality evidence (including analytical [structural and functional] characterization, nonclinical evaluation, pharmacokinetic [PK], pharmacodynamic, clinical assessment comparing with reference product [RP]) supported approval 980,...
Abstract Purpose ABP 980 (KANJINTI ™ ) is a biosimilar to reference product HERCEPTIN ® (trastuzumab RP). The goal of this study was characterize the safety, tolerability, and immunogenicity plus pertuzumab (PERJETA when co-administered in single infusion bag healthy subjects. Methods This randomized, double-blind, single-dose, 2-arm, parallel-group (LAVENDER Study) evaluated an intravenous (IV) (6 mg/kg) (420 mg) combined relative IV trastuzumab RP given over 60 min. subjects were followed...
Abstract Background: NGM707 is a dual antagonist antibody that binds shared epitope of the immune inhibitory receptors ILT2 (LILRB1) and ILT4 (LILRB2). In preclinical studies, reprogrammed suppressive myeloid cells via blockade ILT2/ILT4 enhanced NK CD8+ T cell activity ILT2; furthermore, pembrolizumab acted additively in vitro to enhance CD4+ activation mixed lymphocyte reactions. NGM707-IO-101 (NCT04913337) first-in-human Phase 1/2 clinical trial monotherapy combination with pembrolizumab....
Abstract BACKGROUND: NGM707-IO-101 (NCT04913337) is a Phase 1/2, dose escalation/expansion study evaluating NGM707, humanized monoclonal antibody that blocks ILT2 and ILT4 receptors, as monotherapy or in combination with pembrolizumab. Here we report data from the part of study. METHODS: Eligible patients (pts) advanced/metastatic solid tumors were enrolled into escalating cohorts 200-1800 mg NGM707 combined 200 pembrolizumab, administered Q3W iv. Assessment safety tolerability recommended...
2582 Background: The Phase 1/2, dose escalation/expansion study evaluates NGM707, a dual anti-ILT2/ILT4 humanized monoclonal antibody, as monotherapy or in combination with pembrolizumab patients (pt) advanced solid tumors. Methods: We enrolled pt locally metastatic tumors into dose-escalating cohorts of 6-1800 mg NGM707 and 200-1800 combined 200 pembrolizumab, administered Q3W IV. Primary aim was to assess safety/tolerability dosing expansion cohorts. Secondary/exploratory objectives...