Pegfilgrastim and Biosimilar Yielded Promising Efficacy, Safety Among Patients With MM Post-AlloSCT

Results from a Prospective Cohort Trial

Pegfilgrastim and a pegfilgrastim biosimilar yielded more promising efficacy and safety results than biosimilar filgrastim among patients with multiple myeloma (MM) who had undergone autologous stem cell transplantation (alloSCT), according to findings of a prospective cohort study recently published in Annals of Hematology. 

Massimo Martino, MD, Grande Ospedale Metropolitano “Bianchi-Melacrino-Morelli,”, Reggio Calabria, Italy, and coauthors stated that although novel therapies, such as granulocyte colony-stimulating factor, have improved the mortality rate of patients post-alloSCT, the “data on biosimilar pegfilgrastim-bmez in this setting is lacking.” 

This study compared the efficacy and safety outcomes of patients with MM who received pegfilgrastim after alloSCT with data on historical control groups within the same study center. The control groups used for comparison included patients who received either a filgrastim biosimilar or originator pegfilgrastim. The primary end point was the time to neutrophil engraftment, with secondary endpoints including incidence and duration of febrile neutropenia. 

This study enrolled 231 patients with MM who had previously undergone alloSCT. Of these patients, 73 received originator pegfilgrastim, 102 patients received a filgrastim biosimilar, and 56 patients received a pegfilgrastim biosimilar. 

The median time to neutrophil engraftment was 10 days in the biosimilar pegfilgrastim and originator pegfilgrastim cohorts and 11 days in the biosimilar filgrastim cohort. Of the patients who achieved neutrophil engraftment earlier than the median of 10 days, 58% (n = 29/50) received originator pegfilgrastim. Of the patients who achieved neutrophil engraftment later than the median, 80.8% (n = 59/73) received biosimilar filgrastim. The incidence of febrile neutropenia was 61.4% in the biosimilar filgrastim cohort, which was significantly higher than the incidence in both the originator pegfilgrastim cohort (52.1%) and the biosimilar pegfilgrastim cohort (37.5%). The most common grade 2/3 adverse event was diarrhea (22.5% biosimilar filgrastim cohort; 21.9% originator pegfilgrastim cohort; 5.5% in the biosimilar pegfilgrastim cohort). 

Dr Martino et al concluded, “pegfilgrastim and its biosimilar displayed an advantageous efficacy and safety profile compared with biosimilar filgrastim in patients with MM post-[alloSCT].”

Source: 

Martino M, Gori M, Porto G, et al. Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation. Ann Hematol. Published online April 20, 2023. doi:10.1007/s00277-023-05228-z