Randomized, Double-Blind Study Comparing Proposed Biosimilar La-Ep2006 with Reference Pegfilgrastim in Breast Cancer

Abstract

Aim:This randomized, double-blind trial compared proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer (PROTECT-1).Patients & methods:Women (≥18 years) were randomized to receive LA-EP2006 (n = 159) or reference (n = 157) pegfilgrastim (Neulasta®, Amgen) for ≤6 cycles of (neo)-adjuvant TAC chemotherapy. Primary end point was duration of severe neutropenia (DSN) during cycle 1 (number of consecutive days with absolute neutrophil count <0.5 × 109/l) with equivalence confirmed if 90% and 95% CIs were within a ±1 day margin.Results:For DSN, LA-EP2006 was equivalent to reference (difference: 0.07 days; 90% CI: -0.09–0.23; 95% CI: -0.12–0.26).Conclusion:LA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy.

Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects

“…These findings confirm the low immunological potential of Sandoz proposed biosimilar pegfilgrastim and indicate that the immunological risk is no higher than for the reference pegfilgrastim. These findings are consistent with previous studies that evaluated the immunogenicity of pegfilgrastim and Sandoz proposed biosimilar pegfilgrastim .…”

“…As the PD marker, ANC is a clinically relevant surrogate marker of efficacy in clinical practice; the similar PD profiles reported here support the findings of clinical equivalence from the phase III efficacy and safety studies of Sandoz proposed biosimilar pegfilgrastim and reference pegfilgrastim in cancer patients .…”

“…PK/PD similarity, comparable clinical efficacy, safety and immunogenicity to the reference medicine need to be demonstrated. Regarding Sandoz proposed biosimilar pegfilgrastim, results from two landmark phase III RCTs have been published, demonstrating therapeutic equivalence and comparability in terms of safety and immunogenicity between reference pegfilgrastim and the proposed biosimilar medicine [10,13]. This is supported by the results of a recent meta-analysis that reported no difference between G-CSFs and their biosimilars in terms of efficacy and safety [9].…”

Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies

“…However, these levels are lower than reports from several other randomized controlled studies of patients with breast cancer receiving reference filgrastim (26%–42%) . Studies of patients with breast cancer receiving other G‐CSF products (lipegfilgrastim and pegfilgrastim) have reported incidences of bone pain of 10%–38% . This highlights the considerable variation in the incidence of bone pain between studies of G‐CSF, likely representative of differences in patient populations, study design, chemotherapy regimens, or how bone pain was defined and reported.…”

Febrile neutropenia prophylaxis with short- and long-acting granulocyte colony-stimulating factors during treatment of solid tumours

“…Ziextenzo ® (LA-EP2006) was evaluated in two phase III studies: PROTECT-1 and PROTECT-2 [22,23]. Both studies showed bioequivalence to the reference drug (Neulasta ® ).…”