13.Jan.2015

OCT submitted for approval a phase III trial in diffuse large B-cell lymphoma

OCT has submitted an application to the Ministry of Healthcare of the Russian Federation for approval of the phase III clinical trial in diffuse large B-cell lymphoma (DLBCL).

This is 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.

According to the study protocol, it is planned that seven countries will participate in the trial with a total of 45 to 50 sites involved in the process of enrollment of 250 patients (125 per arm). It is planned that the required number of patients will be recruited within 18 months.

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 after 9 months follow-up and demonstrate comparable pharmacokinetics and pharmacodynamics parameters.

Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL (Non-Hodgkin’s lymphoma) which comprises a heterogeneous group of haematological malignancies. 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.

Several clinical trials previously conducted with the investigational drug have shown that the administration of the investigational drug in combination with CHOP chemotherapy significantly increased the overall response rate, event free survival, and overall survival in elderly patients (≥60 years) with previously untreated diffuse, which makes us hope that the results of the current clinical trial will confirm the expectation regarding the investigational drug efficacy.