Celltrion Healthcare has presented a clinical trial, which showed the efficacy and safety of Truxima is comparable to its original Rituxan in patients with advanced follicular lymphoma (AFL) over two years. The company presented the results at the American Society of Hematology Meeting 2018.
Truxima (Ingredient: rituximab-abbs) is a monoclonal antibody (mAb) biosimilar to Rituxan.
In the two-year trial, 140 randomized AFL patients taking Truxima showed a similar overall survival (OS), progression-free survival (PFS) and sustained response compared to the original.
OS for Truxima and original treatment patients was 93.2 and 95.3 percent, respectively, while PFS was 75.2 and 73.5 percent.
For a sustained response, the rates of recurrence and progression were 19.4 and 21.3 percent, respectively. Also, Truxima showed similar results to the original drugs during the entire treatment period with regards to safety, including tolerability and immunogenicity.
“The results of the two-year clinical trial showed that there is no significant difference between Truxima and original confirming the validity and safety of the biosimilar,” said Christian Buske, medical director at the Comprehensive Cancer Center in Ulm, Germany. “I believe that these results will help to increase further physician confidence in using rituximab biosimilars and will broaden AFL patient access to efficacious and affordable therapies.”
Kim Ho-ung, Celltrion Healthcare’s head of strategy and operations division, also said, “The two-year study marks another significant milestone for Celltrion Healthcare, showing that Truxima is comparable to reference rituximab regarding overall survival and progression-free survival. Now that Truxima is approved in the US, 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, Truxima will reduce the burden on healthcare systems resulting in better patient outcomes, Kim added.
The company published the results of the trial in the Lancet Hematology, an international journal on that focuses on the hematological clinical practice.