Nadia Harbeck1, Pere Gascon2, Clyde M Jones3, Allen Nixon4, Andriy Krendyukov5, Roumen Nakov5, Yuhan Li6, Kimberly Blackwell7. 1. Brustzentrum, Frauenklinik & CCCLMU der Universität München (LMU), Munich, 81337, Germany. 2. Servicio de Oncologia Médica, Fundacio Clinic, Barcelona, 08036, Spain. 3. The Jones Clinic, Memphis, TN, 38138, USA. 4. Fowler Family Center for Cancer Care, Jonesboro, AR, 72401, USA. 5. Hexal AG, Holzkirchen, Germany. 6. Sandoz Inc, Princeton, NJ, 08540, USA. 7. Duke Cancer Institute, Durham, NC, 27710, USA.
Abstract
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®, 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 × 109/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.
RCT Entities:
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®, 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 × 109/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.
Entities:
Keywords:
biosimilars; breast cancer: Asian patients; granulocyte colony-stimulating factor; neutropenia; pegfilgrastim