Truxima (rituximab-abbs), a biosimilar to Rituxan (rituxumab), has similar safety and efficacy as the original product in patients with advanced follicular lymphoma after two years, results from a Phase 3 trial show.
The trial — which showed comparable two-year survival and progression-free survival rates, along with similar relapse rates — continues to demonstrate that Truxima is not inferior to Rituxan across multiple indications, which “will help to further increase physician confidence in using rituximab biosimilars,” Christian Buske, of Germany’s University Hospital Ulm, said in a press release.
The findings were presented at the American Society of Hematology (ASH) 2018 Meeting, Dec. 1-4, in San Diego, California, in the study, “Similar Efficacy and Safety of CT-P10 and Reference Rituximab in Patients with Advanced Stage Follicular Lymphoma: Updated Phase III Study Results.”
Celltrion‘s Truxima (CT-P10), like its original medicine Rituxan, is an antibody that targets the CD20 molecule found in healthy B-cells and lymphoma cells. By inhibiting the excessive growth and spread of B-cells, the treatment improves lymphoma symptoms.
The treatment is approved for all Rituxan’s indications in the European Union and was recently approved in the U.S. for three non-Hodgkin’s lymphoma indications.
The approvals were in part based on the CT-P10 3.3 Phase 3 trial (NCT02162771), which showed that Truxima has similar safety and efficacy as Rituxan, when given in combination with CVP chemotherapy — cyclophosphamide, vincirstine, and prednisone — to advanced follicular lymphoma patients who had not received any prior treatment.
Now, researchers report updated results from CT-P10 3.3 after nearly two years of follow-up.
The trial included 140 patients who randomly received Truxima or Rituxan, plus CVP chemotherapy, as an induction treatment. The 122 patients who achieved a response during the induction period continued receiving Truxima or Rituxan alone as a maintenance therapy.
After a median follow-up of 23 months, a similar proportion of patients had experienced disease relapse, disease progression, or death from any cause — 22.9% in the Truxima group versus 24.3% in the Rituxan group.
At two years, the proportion of patients who were still alive and without signs of disease worsening were also comparable — 75.2% versus 73.5% — as was the number of patients who lived past the two-year mark – 93.2% versus 95.3%.
Among patients who responded to induction therapy — 62 on Truxima and 60 on Rituxan — the proportion who experienced a relapse or disease progression was similar — 19.4% versus 21.3%.
Truxima was well-tolerated and showed a safety profile that matched that of Rituxan over the 23 months of treatment.
“CT-P10 has already demonstrated non-inferiority of efficacy compared with reference rituximab combined with CVP in previously untreated AFL,” said Buske, a professor and medical director at the Comprehensive Cancer Center in Ulm. “The study results … have further strengthened these findings, showing no statistically meaningful difference between CT-P10 and reference rituximab for over two years and demonstrating a proven safety profile.”
“The two-year study marks another milestone for Celltrion Healthcare, showing that CT-P10 is comparable to reference rituximab in terms of overall survival and progression-free survival,” said HoUng Kim, Celltrion’s head of strategy and operations division.
Biosimilars are biological medical products that are nearly identical to an original product, but manufactured by a different company after the original product’s patent expires. They usually are sold at significantly lower prices.
“Now that CT-P10 is approved in the U.S., the availability of the first rituximab biosimilar has the potential to significantly improve access to rituximab for patients with non-Hodgkin’s lymphoma indications. As a cost-effective alternative to the reference product, CT-P10 will reduce the burden on healthcare systems, resulting in better patient outcomes.”
