Positive Results for CT-P10 as Treatment for Advanced Follicular Lymphoma
New data shows that the efficacy and safety of CT-P10 is comparable to reference rituximab in patients with advanced follicular lymphoma (AFL) over 2 years. The findings were presented at the 2018 ASH Annual Meeting (Abstract 1616).
The efficacy and safety of CT-P10 was evaluated in a randomized, double-blind, phase III study which evaluated the overall survival (OS), progression-free survival (PFS), and sustained response in comparison to the reference biologic rituximab. The median follow-up duration was 23 months.
One hundred forty patients were enrolled in a 1:1 ratio and 124 patients completed 8 cycles of chemotherapy (R-CVP induction). One hundred twenty-two patients (62 patients in the CT-P10 group and 60 patients in the reference rituximab group) who showed response during the induction period, entered the maintenance period where a total of 12 cycles of rituximab monotherapy was to be administered every 2 months.
The results showed that at the median follow-up duration of 23 months, the updated efficacy data in AFL patients demonstrated comparable OS (2-year OS of 93.2% and 95.3% for CT-P10 and reference rituximab, respectively) and PFS (2-year PFS was 75.2% and 73.5% for CT-P10 and reference rituximab, respectively). In terms of sustained response, the proportion of patients who showed relapse or disease progression after achieving overall response was 19.4 percent (13/67) in the CT-P10 group and 21.3 percent (13/61) in the reference rituximab group. CT-P10 was also well-tolerated and its safety profile including immunogenicity of CT-P10 was comparable to that of reference rituximab over 23 months of treatment.
Christian Buske, Professor, Medical Director at the Comprehensive Cancer Center Ulm, Germany, Institute of Experimental Cancer Research and Attending Physician and Professor of Medicine at the Medical Department for Internal Medicine III, Hematology/Oncology, University Hospital Ulm said, “CT-P10 has already demonstrated non-inferiority of efficacy compared with reference rituximab combined with CVP in previously untreated AFL. The study results presented [at ASH] have further strengthened these findings, showing no statistically meaningful difference between CT-P10 and reference rituximab for over 2 years and demonstrating a proven safety profile. I believe that these results will help to further increase physician confidence in using rituximab biosimilars and will broaden AFL patient access to efficacious and affordable therapies.”
Also presented at ASH and published in The Lancet Haematology, is data from the CT-P10 3.4 LTBFL trial which aimed to demonstrate therapeutic equivalence of CT-P10 to reference rituximab (as monotherapy) in patients with previously untreated low tumor burden follicular lymphoma (LTBFL) (Abstract 1596).
The results showed that CT-P10 was well-tolerated and the safety profile was comparable to that of reference rituximab over 7 months. Eighty-three percent (108 of 130) patients assigned to CT-P10 and 104 (81%) of 128 assigned to rituximab achieved an overall response by month seven (treatment difference estimate 1·8%; 90% CI –6·43 to 10·20) and therapeutic equivalence was shown (90% CIs were within the prespecified margin of 17%).