LBA2 - Proposed biosimilar pegfilgrastim (LA-EP2006) compared with reference pegfilgrastim in Asian patients with breast cancer receiving myelotoxic chemo...

Date 19 December 2016
Event ESMO Asia 2016 Congress
Session Breast cancer
Presenter Nadia Harbeck
Citation Annals of Oncology (2016) 27 (suppl_9): ix190-ix191. 10.1093/annonc/mdw637
Authors N. Harbeck1, P. Gascon2, C..M. Jones3, A. Nixon4, A. Krendyukov5, R. Nakov6, M. Mo7, K.L. Blackwell8
  • 1Brustzentrum, LMU Klinikum der Universität München, 81377 - München/DE
  • 2Laboratory Of Molecular & Translational Oncology-cellex, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 3Oncology/hematology, The Jones Clinic, 38138 - Germantown/US
  • 4Oncology Research, Fowler Family Center for Cancer Care, 72401 - Jonesboro/US
  • 5Hematology&oncology/nephrology, Hexal AG, D-83607 - Holzkirchen/DE
  • 6Hematology, Hexal AG, D-83607 - Holzkirchen/DE
  • 7Biostatistics, Sandoz Inc, 08540 - Princeton/US
  • 8Duke Cancer Institute, Duke University Medical Center, 27710 - Durham/US

Abstract

Background

Two prospective, double-blind, randomized, phase III trials (PROTECT1 and 2) showed similar efficacy and safety with proposed biosimilar pegfilgrastim (LA-EP2006) and reference pegfilgrastim (Neulasta®, Amgen Inc.) in patients with breast cancer receiving myelotoxic chemotherapy. Here, we present a pooled subgroup analysis of patients of Asian ethnicity enrolled in these trials.

Methods

Adult chemotherapy-naïve women with breast cancer scheduled to receive (neo)-adjuvant chemotherapy (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2, ≤6 cycles) were enrolled in two trials of similar design. Patients were randomized to 6 mg of LA-EP2006 or reference pegfilgrastim on Day 2 of each cycle. Primary endpoint was duration of severe neutropenia (DSN) (number of consecutive days with absolute neutrophil count [ANC] 

Results

A total of 174 Asian patients were randomized (LA-EP2006: n = 90; reference: n = 84). Baseline characteristics were similar in both groups. Mean DSN in Cycle 1 was 1.36 ± 0.98 days (LA-EP2006) versus 1.35 ± 1.06 days (reference) (difference 0.01 days; 95% CI: −0.30, 0.32, indicating equivalence). There were no clinically meaningful differences between groups in secondary endpoints. Treatment-emergent adverse events (TEAEs) were similar across groups (LA-EP2006: 96.7%; reference: 97.6%) (all cycles). Serious TEAEs were reported in: LA-EP2006: 31.1%; reference: 32.1% (all cycles). No neutralizing anti-pegfilgrastim antibodies were detected.

Conclusions

In Asian patients with breast cancer receiving cytotoxic chemotherapy, LA-EP2006 showed similar clinical efficacy and safety compared with reference pegfilgrastim. These data were similar to the overall study population.

Clinical trial indentification

NCT01735175, NCT01516736

Legal entity responsible for the study

Sandoz GmbH, Kundl, Austria

Funding

Sandoz GmbH, Kundl, Austria.

Disclosure

N.H.: Honoraria for lectures (Amgen). Honoraria for lectures/consulting (Sandoz/Hexal). Chair of Data safety Monitoring Board. A.K., R.N.: Employee of Hexal AG. M.M.: Employee of Sandoz Inc. K.L.B.: Honoraria for consulting (Sandoz, Novartis). All other authors have declared no conflicts of interest.