Celltrion Healthcare: The Lancet Haematology publishes results from phase 3 clinical trial of Truxima® (CT-P10, biosimilar rituximab) in patients with
- Data show that CT-P10 is comparable to reference rituximab in terms of efficacy and safety
The Lancet Haematology published detailed results from the ongoing phase 3, double-blind, randomised, parallel-group, active-controlled study of CT-P10.[1]
A total of 140 patients with advanced follicular lymphoma were enrolled to explore the comparability between CT-P10 and reference rituximab when used in combination with cyclophosphamide, vincristine and prednisone (CVP). The data for the eight-cycle induction period up to week 24 study found non-inferior efficacy and pharmacokinetic equivalence of CT-P10 compared with reference rituximab.
Following presentations at the 2017 International Conference on Malignant Lymphoma and the 22nd Congress of European Hematology Association, the findings from the study demonstrated that the proportion of patients with an overall response was 97.0 and 92.6% in CT-P10 and reference rituximab groups, respectively, and the difference was laid on the positive side of the predefined non-inferiority margin. Therefore, the predefined non-inferiority criterion was met with both the protocol-specified point estimate difference approach and the conventional statistical non-inferiority test, confidential interval approach.
The pharmacokinetics of CT-P10 and reference rituximab were equivalent, and the safety profile of CT-P10 was comparable to that of reference rituximab, with the proportion of patients who experienced treatment-emergent adverse events being 83% in the CT-P10 treatment group and 80% in the reference rituximab group.
Dr Kwon, Medical Director of Celltrion Healthcare, said: “Increasing wealth of evidence supports comparability of our biosimilar rituximab, CT-P10, to reference rituximab. Biosimilar rituximab is a cost-effective alternative to reference rituximab, and has potential to decrease the burden on healthcare systems. We strongly believe that CT-P10 could represent a new therapeutic option for patients with lymphoma and improve patient access to innovative new medications and new combination therapies across oncology indications in many countries throughout the world.”
[1] Kim, Won Seog, et al. "Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial." The Lancet Haematology. 2017. doi: 10.1016/S2352-3026(17)30120-5.