Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer

Nadia Harbeck, Oleg Lipatov, Mona Frolova, Dmitry Udovitsa, Eldar Topuzov, Doina Elena Ganea-Motan, Roumen Nakov, Pritibha Singh, Anita Rudy, Kimberly Blackwell, Nadia Harbeck, Oleg Lipatov, Mona Frolova, Dmitry Udovitsa, Eldar Topuzov, Doina Elena Ganea-Motan, Roumen Nakov, Pritibha Singh, Anita Rudy, Kimberly Blackwell

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 × 10(9)/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.

Keywords: biosimilars; granulocyte-colony-stimulating factor; pegfilgrastim.

Conflict of interest statement

Financial & competing interests disclosure

This work was supported by Sandoz GmbH, Kundl, Austria. N Harbeck has provided advisory or consulting services to Amgen and Sandoz GmbH, Kundl, Austria. K Blackwell has provided advisory or consulting services to Sandoz GmbH, Kundl, Austria. M Frolova has provided advisory or consulting services to Astra Zeneca, Biocad, Roche, Sanofi and Sandoz GmbH, Kundl, Austria. R Nakov, P Singh and A Rudy are employees of Hexal AG (a Sandoz company), Holzkirchen, Germany. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Editorial support was provided by Andy Bond and Caroline McGown of Spirit Medical Communications Ltd, supported by Sandoz GmbH, Kundl, Austria.

Figures

Figure 1. . Patient disposition.
Figure 1.. Patient disposition.
AE: Adverse event; FAS: Full analysis set; PP: Per-protocol; SAF: Safety analysis.
Figure 2. . Absolute neutrophil count time…
Figure 2.. Absolute neutrophil count time course during cycle 1 (mean ± standard devation; full analysis set).
The horizontal line indicates the threshold of 2 × 109/l defined for ANC recovery. ANC: Absolute neutrophil count.

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