In a nutshell
This study aims to investigate the long-term effectiveness and safety of the rituximab biosimilar CT-P10 (Truxima) in combination with cyclophosphamide (Cytoxan), vincristine (Oncovin), and prednisone (Deltasone) (CVP) compared with rituximab (Rituxan) for the treatment of advanced-stage follicular lymphoma (FL). The study concluded that the overall safety and long-term effectiveness of CT-P10 are similar to rituximab for the treatment of FL.
Follicular lymphoma (FL) is a slow-growing type of non-Hodgkin lymphoma (NHL). It arises from B-cell lymphocytes, a type of white blood cell. Rituximab, a CD-20 antibody in combination with CVP chemotherapy is a preferred first-line therapy for treatment of advanced FL.
CT-P10 is a rituximab biosimilar that has been approved by the FDA for its similarity in effectiveness for FL treatment. A biosimilar drug is very close in structure and function to the original drug. It is usually significantly cheaper compared to the original drug. The substantial cost savings allows CT-P10 wide access to patients.
However, the long-term effectiveness and safety for CT-P10 in comparison to rituximab in patients with advanced FL are still unknown.
Methods & findings
This study involved 140 patients with advanced FL. Patients were randomly assigned to receive either rituximab with CVP (70; group 1) or CT-P10 with CVP (70; group 2). The average follow-up period was 39.9 months.
After 4 years, 55% in group 1 and 61% o in group 2 were alive without cancer worsening. Overall survival rates after 4 years were 93% for group 1 and 88% for group 2.
90% of patients in group 2 and 86% in group 1 experienced side effects related to treatment. Infusion related reactions and low white blood cells were the most common side effects in both groups.
The bottom line
The study concluded that the long-term effectiveness and safety for CT-P10 with CVP were similar to rituximab and CVP for patients with advanced FL.
The fine print
The study was supported and funded by Celltrion, the manufacturer of CT-P10.
Published By :
Sep 14, 2021
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