International multicentre clinical trial confirms efficacy and safety of proposed biosimilar BCD-020 in comparison with reference rituximab in indolent lymphoma patients
Clinical trials are a final step of biosimilar development. In this international multicentre study, appropriately designed with a sensitive primary endpoint and conducted in a sensitive population, rituximab biosimilar BCD-020 goes head-to-head with its reference product.
Rituximab induces lysis of B cells expressing this surface antigen and has revolutionized treatment against B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia. However, because the high cost has limited patient access to this highly demanded treatment in many parts of the world, rituximab biosimilar development is warranted. BCD-020 is a proposed biosimilar with analogous molecular structure and quality characteristics to reference rituximab, as shown preclinically in vitro and in vivo. To compare clinical safety and efficacy of BCD-020 versus reference rituximab given as monotherapy, an international, multicentre, randomised phase III study was performed in patients with indolent lymphoma.
The trial confirmed equivalence of the two drugs for the primary endpoint. After a 4-week treatment period, the overall response rate in BCD-020 and rituximab groups was 45% and 42%, respectively – a statistically non-significant difference. The two drugs were associated with comparable rates of complete remission, partial remission, and stable disease. Progressive disease was noted in 8% in the BCD-020 group and 15% in the reference group. Adverse events, immunogenicity, pharmacokinetics, and pharmacodynamics findings (the latter as suggested by dramatic reductions of blood CD20+ cell counts) were similar in both groups.
The novel biosimilar BCD-020 exerts comparable overall response rates and an equal safety profile to reference rituximab in patients with indolent lymphoma. There were no substantial differences between study drug and comparator in all test parameters indicative of efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics. Considering the significant role of rituximab in the treatment of B-cell cancers and affordability of biosimilars, the incorporation of rituximab biosimilar into clinical practice may have tremendous positive benefits.
Rituximab biosimilar BCD-020 has analogous molecular structure and quality characteristics to reference rituximab. In a recent study, BCD-020 had comparable overall response rates and similar safety profiles to reference rituximab in patients with indolent lymphoma.