Abstract
Pegfilgrastim is indicated for reducing the duration of neutropenia and incidence of febrile neutropenia in patients receiving cytotoxic chemotherapy. Here, safety and efficacy of MYL-1401H, a proposed pegfilgrastim biosimilar, were investigated as prophylaxis for chemotherapy-induced neutropenia. This was a phase 3, multicenter, randomized, double-blind, parallel-group equivalence trial of MYL-1401H vs European Union–sourced reference pegfilgrastim. Patients with newly diagnosed stage II/III breast cancer eligible to receive (neo) adjuvant chemotherapy with docetaxel/doxorubicin/cyclophosphamide every 3 weeks for 6 cycles were enrolled and randomized 2:1 to 6 mg of MYL-1401H or reference pegfilgrastim 24 h (+ 2-h window after the first 24 h) after the end of chemotherapy. The primary efficacy endpoint was the duration of severe neutropenia in cycle 1 (i.e., days with absolute neutrophil count (ANC) < 0.5 × 109/L). Mean (standard deviation (SD)) duration of severe neutropenia in MYL-1401H and reference pegfilgrastim groups was 1.2 days (0.93) and 1.2 days (1.10), respectively. The 95% CI for least squares mean difference (− 0.285, 0.298) was within the predefined equivalence range of ± 1 day. Secondary endpoints, including grade ≥ 3 neutropenia (frequency, 91% and 82% for MYL-1401H and reference pegfilgrastim, respectively), time to ANC nadir (mean (SD), 6.2 (0.98) and 6.3 (1.57) days), and duration of post-nadir recovery (mean (SD), 1.9 (0.85) and 1.7 (0.91) days) were comparable. Overall safety profiles of the study drugs were comparable. MYL-1401H demonstrated equivalent efficacy and similar safety to reference pegfilgrastim and may be an equivalent option for reducing incidence of neutropenia. (ClinicalTrials.gov, NCT02467868; EudraCT, 2014-002324-27).
Highlights
Biologics have great therapeutic promise but are limited by cost and availability [1]
Filgrastim, which has been used for febrile neutropenia (FN) prophylaxis in patients receiving myelosuppressive chemotherapy for > 25 years, was among the first drugs to have biosimilar versions approved by the European Medicines Agency (EMA) (2008) and Food and Drug Administration (FDA) (2015) [6,7,8]
All 6 chemotherapy cycles were completed by 120 patients in the MYL-1401H group and 66 in the reference pegfilgrastim group
Summary
Biologics have great therapeutic promise but are limited by cost and availability [1]. As biologics lose patent protection, biosimilar development may reduce costs and expand access [1,2,3]. Extended author information available on the last page of the article the US Food and Drug Administration (FDA) established guidance for biosimilar development and approval [4, 5]. Filgrastim, which has been used for febrile neutropenia (FN) prophylaxis in patients receiving myelosuppressive chemotherapy for > 25 years, was among the first drugs to have biosimilar versions approved by the EMA (2008) and FDA (2015) [6,7,8]. Clinical studies have shown that filgrastim biosimilars have pharmacologic, safety, and efficacy profiles comparable to the originator product [11,12,13,14,15]
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