The approval has been received in the framework of a randomized, double-blind, phase III study comparing the efficacy and safety of the investigational drug which is Biosimilar in combination with CHOP Chemotherapy Versus a Reference drug in combination with CHOP in patients with Diffuse large B-cell lymphoma given as first line.
The primary objective of the study is to determine if the response rate obtained with the investigational drug combined with CHOP is non-inferior to the RR obtained with the reference drug in patients with DLBCL. Secondary objective include evaluation of safety and event free survival in both treatment arms after 9 months follow-up and demonstrate comparable pharmacokinetics and pharmacodynamics parameters as well as comparison of immunogenicity between the investigational medicinal product and reference drug.
13 countries including Argentina, Brazil, Indonesia, Mexico, Paraguay, South Africa, India, Malaysia, Philippines, Thailand, Colombia, Iran and Russia have been involved in the study. According to the study protocol, 17 medical centers are going to participate in the trial in the Russian Federation, and 40 patients are planned to be enrolled (20 persons per treatment arm). It is estimated that the required number of patients will be recruited within the period of 10 months. The first patients are going to be randomized in August, 2015, while the study is planned to be completed by May, 2018.
Non-Hodgkin’s lymphoma (NHL) comprises a heterogeneous group of haematological malignancies with diffuse large B-cell lymphoma (DLBCL) being a common type of NHL, accounting for about 40 percent of new cases of lymphoma. DLBCL can occur at any time between adolescence and old age. The most common age to be diagnosed is around 60 and it is slightly more common in men than in women. According to the World Health Organization and the the Haematological Malignancy Research Network, the annual incidence of DLBCL among adults is 7-8 cases per 100 000 people per year, so the world healthcare community is in need for new therapies to treat this disease.
The investigational product is a chimeric mouse/human monoclonal antibody, consisting of a glycosylated IgG1-κ immunoglobulin with murine light- and heavy-chain variable regions (Fab domain) and human κ and γ-1 constant regions (Fc domain). The IP binds to CD20, a transmembrane phosphorylated protein, located on pre-B and matures B-lymphocytes (B-cell lineage-restricted pan-B cell antigen). The antigen is found on both normal B-cells and malignant B-cells (except from myeloma cells and most precursors B cell ALL).
This is a full-service clinical project, including site selection, clinical monitoring, project management, warehousing, study materials purchase and other logistics assistance, safety management; OCT is also providing regulatory activities, final report preparation, others. In addition OCT provides data management and final statistical report preparation services in this study. OCT’s self-developed CTMS is used as a data management platform in this trial.