Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study

Jurczak, Wojciech; Moreira, Ilídia; Kanakasetty, Govind Babu; Munhoz, Eduardo; Echeveste, M Asuncion; Giri, Pratyush; Castro, Nelson; Pereira, Juliana; Akria, Luiza; Alexeev, Sergey; Osmanov, Eugeniy; Zhu, Peijuan; Alexandrova, S.; Zubel, Angela; Harlin, Olof; Amersdorffer, Jutta

doi:10.1016/s2352-3026(17)30106-0

Cited by 73 publications

(74 citation statements)

References 23 publications

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“…The rituximab (RTX) biosimilar GP2013 has been developed using a stepwise approach comprising extensive physicochemical and functional characterization followed by in vitro bioassays as well as in vivo preclinical studies (2). Equivalence of pharmacokinetics and pharmacodynamics as well as similar efficacy, safety, and immunogenicity between GP2013 | 89 and reference RTX have been demonstrated in 2 randomized, double-blind, controlled trials in patients with rheumatoid arthritis (RA) (3) and non-Hodgkin's lymphoma (follicular lymphoma) (4).…”

Section: Introductionmentioning

confidence: 99%

Safety and Immunogenicity of Rituximab Biosimilar GP2013 After Switch From Reference Rituximab in Patients With Active Rheumatoid Arthritis

Tony

Krüger

Cohen

et al. 2018

Arthritis Care & Research

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Objective. Comparable clinical efficacy of the rituximab (RTX) biosimilar GP2013 and reference RTX has been established in blinded randomized trials. However, when switching from a reference biologic to a biosimilar, potential safety implications are often an important consideration. Therefore, the aim of this study was to evaluate the safety of switching from reference RTX to RTX biosimilar GP2013 compared with treatment continuation with reference RTX in patients with rheumatoid arthritis (RA).Methods. In this multinational, randomized, double-blind, parallel-group safety study, 107 patients with RA who had previously received treatment (of any duration) with reference RTX as part of routine practice and who required continuation of treatment were randomized to receive either GP2013 or to continue treatment with reference RTX. All patients received a stable dosage of methotrexate and folic acid during the study. Study assessments included the incidence of hypersensitivity, infusion-related and anaphylactic reactions, immunogenicity (antidrug antibodies), and general safety.Results. Regardless of whether patients switched to GP2013 or continued treatment with reference RTX, the incidences of hypersensitivity (9.4% and 11.1%, respectively) and infusion-related reactions (11.3% and 18.5%, respectively) were similarly low. Only 1 patient (in the reference RTX group) developed antidrug antibodies to RTX after starting study treatment. No neutralizing antidrug antibodies were observed. Antidrug antibodies were not associated with adverse events (AEs). No clinically meaningful differences in the rate of AEs were observed between treatment groups.Conclusion. No safety risks were detected when patients switched from reference RTX to GP2013. The safety profiles of patients in both treatment groups were similar, although the study was not powered for statistical testing of equivalence in safety.ClinicalTrials.gov (NCT02514772).

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Section: Introductionmentioning

confidence: 99%

Safety and Immunogenicity of Rituximab Biosimilar GP2013 After Switch From Reference Rituximab in Patients With Active Rheumatoid Arthritis

Tony

Krüger

Cohen

et al. 2018

Arthritis Care & Research

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“…In three of them, JASMINE, CT‐P10 3.4, and REFLECTIONS B328‐06, rituximab monotherapy is used. In two others, ASSIST‐FL and CT‐P10 3.3, combination treatment is studied. In all these studies, proposed rituximab biosimilars and reference rituximab are used in parallel arms in previously untreated follicular lymphoma patients with overall response rate as a primary efficacy endpoint.…”

Section: Discussionmentioning

confidence: 99%

Proposed rituximab biosimilar BCD‐020 versus reference rituximab for treatment of patients with indolent non‐Hodgkin lymphomas: An international multicenter randomized trial

Poddubnaya

Алексеев

Kaplanov

et al. 2020

Hematological Oncology

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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/m 2 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 in comparator arm. The overall response rate was 44.71% in BCD-020 arm and 41.89% in comparator arm. Limits of 95% confidence interval (CI) for difference of overall response rates between arms were (−12.62%-18.24%) showing equivalent efficacy.Sixty-one (68.54%) and 59 (69.41%) patients had at least one adverse event in BCD-020 arm or comparator arm, respectively. No unexpected adverse reactions were reported.Antidrug antibodies with no neutralizing activity were detected in two patients in comparator arm on day 14 further declining below detection threshold.Rituximab concentrations had equivalent pattern after intravenous administration of both drugs. Both drugs caused depletion of B-cells without significant influence on other blood cell lineages.In this study, we showed equivalent efficacy of BCD-020 and reference rituximab when used in patients with CD20-positive indolent lymphomas. We also confirmed pharmacokinetic equivalence of BCD-020 and reference rituximab. Safety profile,

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“…GP2013 has also been approved in the European Union for its efficacy data from a phase 3 trial in FL (ASSIST-FL, NCT01419665). 35 The phase 3 study (NCT02213263) of PF-05280586 displayed positive results as well. 36 Moreover, ABP798 is currently under study (NCT02747043).…”

Section: Cd20mentioning

confidence: 98%

Advances in targeted therapy for malignant lymphoma

Wang

Qin

Huo

et al. 2020

Sig Transduct Target Ther

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The incidence of lymphoma has gradually increased over previous decades, and it ranks among the ten most prevalent cancers worldwide. With the development of targeted therapeutic strategies, though a subset of lymphoma patients has become curable, the treatment of refractory and relapsed diseases remains challenging. Many efforts have been made to explore new targets and to develop corresponding therapies. In addition to novel antibodies targeting surface antigens and small molecular inhibitors targeting oncogenic signaling pathways and tumor suppressors, immune checkpoint inhibitors and chimeric antigen receptor T-cells have been rapidly developed to target the tumor microenvironment. Although these targeted agents have shown great success in treating lymphoma patients, adverse events should be noted. The selection of the most suitable candidates, optimal dosage, and effective combinations warrant further investigation. In this review, we systematically outlined the advances in targeted therapy for malignant lymphoma, providing a clinical rationale for mechanism-based lymphoma treatment in the era of precision medicine.Signal Transduction and Targeted Therapy (2020) 5:15; https://doi.

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Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study

Cited by 73 publications

References 23 publications

Safety and Immunogenicity of Rituximab Biosimilar GP2013 After Switch From Reference Rituximab in Patients With Active Rheumatoid Arthritis

Safety and Immunogenicity of Rituximab Biosimilar GP2013 After Switch From Reference Rituximab in Patients With Active Rheumatoid Arthritis

Proposed rituximab biosimilar BCD‐020 versus reference rituximab for treatment of patients with indolent non‐Hodgkin lymphomas: An international multicenter randomized trial

Advances in targeted therapy for malignant lymphoma

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