Study Shows Similar Safety, Efficacy of Reference and Biosimilar Filgrastim in DLBCL

July 12, 2017
The Center for Biosimilars Staff

Biosimilar filgrastim is used to prevent chemotherapy-induced neutropenia and febrile neutropenia, but there exist only limited observational data concerning the use of granulocyte-colony stimulating factor treatments in patients who have non-Hodgkin’s lymphoma, including sub-types such as diffuse large B-cell lymphoma.

Biosimilar filgrastim is used to prevent chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN), but observational data are limited on the use of granulocyte-colony stimulating factor (G-CSF) treatments in patients who have non-Hodgkin’s lymphoma, including sub-types such as diffuse large B-cell lymphoma (DLBCL).

A recent pan-European, multi-center, prospective, observational study, the results of which were published in a June 2017 issue supplement of Hematological Oncology, examined the treatment patterns and clinical outcomes of patients who received biosimilar filgrastim to prevent CIN and FN, and to describe outcomes for patients who have DLBCL.

The study cohort included a total of 245 patients who had either stage 3 (42%) or stage 4 (58%) DLBCL. The patients received up to 6 cycles of chemotherapy. The results of the study were as follows:

  • CIN occurred in 16.7% (n = 41) of patients in the first cycle and in 35.5% (n = 87) in all cycles
  • FN occurred in 2.4% (n = 6) of patients in the first cycle and in 9.8% of patients (n = 24) in all cycles
  • Grade 3 to 4 FN occurred in 2% of patients (n = 5) in the first cycle and 9.4% of patients (n = 23) in all cycles

Among adverse events (AEs), patients most frequently reported bone pain (2.9%, n = 7), arthralgia (0.8%, n = 2), and back pain (.08%, n = 2). Other AEs, each reported by 0.4% of patients (n = 1), included increased blood alkaline phosphate, constipation, acute hepatitis, musculoskeletal pain, and pyrexia.

The researchers concluded that the biosimilar filgrastim’s efficacy and safety in real-life practice in patients with DLBCL was similar to that of the reference filgrastim. They belive that these data support the use of biosimilar filgrastim in real-world practice, and that biosimilars present an opportunity to increase the sustainability of cancer treatment.

The study findings echo those of other recent studies that have supported the safety and efficacy of biosimilar filgrastim, including those that demonstrated no significant differences between biosimilar and reference filgrastim in the mobilization of peripheral blood stem cells, and no clinically meaningful differences in patients who switched between biosimilar filgrastim and its reference.