LA-EP2006, a biosimilar agent to pegfilgrastim, and reference pegfilgrastim were therapeutically equivalent and comparable in terms of efficacy and safety in the prevention of chemotherapy-induced neutropenia in patients with early stage breast cancer receiving docetaxel, doxorubicin, and cyclophosphamide, according to a study published in the journal The Oncologist.1
Pegfilgrastim is a widely used agent for the prevention of chemotherapy-induced neutropenia. Unlike with filgrastim, no biosimilar product for pegfilgrastim is available. A biosimilar product offers to increase the affordability of treatment compared with its reference product without compromising quality, safety, or efficacy.
Therefore, researchers sought to compare LA-EP2006, a proposed biosimilar to pegfilgrastim, with reference pegfilgrastim in patients with early stage breast cancer receiving adjuvant or neoadjuvant myelosuppressive chemotherapy.
For the phase 3 study, researchers enrolled 308 patients fit to receive intravenous docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2. Participants received chemotherapy on day 1 of each cycle for 6 or more cycles.
Patients were randomly assigned to receive LA-EP2006 or pegfilgrastim 6 mg/0.6 mL subcutaneously on day 2 of each cycle.
Results showed that the duration of severe neutropenia during cycle 1 was equivalent between treatment arms. Safety profiles were also similar between the biosimilar product and reference pegfilgrastim.
“Biosimilar pegfilgrastim (LA-EP2006) may benefit oncology patients by offering increased access to biological treatments that may improve clinical outcomes,” the authors concluded. “This means that patients could potentially be treated prophylactically with biologics rather than only after complications have occurred.”
1. Blackwell K, Donskih R, Jones MC, et al. A comparison of proposed biosimilar LA-EP2006 and reference pegfilgrastim for the prevention of neutropenia in patients with early-stage breast cancer receiving myelosuppressive adjuvant or neoadjuvant chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a phase III, randomized, double-blind trial [published online ahead of print April 18, 2016]. Oncologist. doi:10.1634/theoncologist.2016-0011.