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Harbeck, Nadia; Gascon, Pere; Jones, Clyde M.; Nixon, Allen; Krendyukov, Andriy; Nakov, Roumen; Li, Yuhan; Blackwell, Kimberly (2017): Proposed biosimilar pegfilgrastim (LA-EP2006) compared with reference pegfilgrastim in Asian patients with breast cancer: an exploratory comparison from two Phase III trials. In: Future Oncology, Vol. 13, No. 16: pp. 1385-1393
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Aim: This is a pooled subgroup analysis of Asian patients enrolled in two Phase III confirmatory studies comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer. Patients & methods: Women were randomized to LA-EP2006 (n = 90) or reference (n = 84) pegfilgrastim (Neulasta (R), Amgen, Inc., CA, USA) for <= 6 cycles of TAC chemotherapy. Primary end point was duration of severe neutropenia during Cycle 1 (number of consecutive days with absolute neutrophil count <0.5 x 10(9)/l) with equivalence confirmed if 95% CIs were within a +/- 1-day margin. Results: Mean duration of severe neutropenia (days) in Cycle 1 was 1.36 +/- 0.98 (LA-EP2006) versus 1.35 +/- 1.06 (reference) (difference 0.01 days;95% CI: -0.30-0.32, indicating equivalence). Conclusion: LA-EP2006 showed similar clinical efficacy and safety compared with reference pegfilgrastim.