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Breast cancer, early stage

1526 - One-year safety, immunogenicity, and survival results from a phase III study comparing SB3 (a proposed trastuzumab biosimilar) and originator trastuzumab in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment


09 Sep 2017


Breast cancer, early stage


Cytotoxic Therapy;  Breast Cancer


Xavier Pivot


Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362


X. Pivot1, I.M. Bondarenko2, Z. Nowecki3, M. Dvorkin4, E. Trishkina5, J.H. Ahn6, Y. Vinnyk7, S. Im8, T. Sarosiek9, S. Chatterjee10, M. Wojtukiewicz11, V. Moiseyenko12, Y. Shparyk13, M. Bello III14, V. Semiglazov15, L. Younju16, J. Lim17

Author affiliations

  • 1 Oncology, CHU Besançon, Hôpital Jean Minjoz, 25030 - Besançon/FR
  • 2 Oncology, Municipal Institution "Dnipropetrovsk City Multi-field Clinical Hospital #4", Dnepropetrovsk state m, 49102 - Dnepropetrovsk/UA
  • 3 Oncology, The Maria Sklodowska-Curie Memorial Institute and Oncology Centre, 02-781 - Warsaw/PL
  • 4 Oncology, BHI of Omsk region “Clinical Oncology Dispensary”, 644013 - Omsk/RU
  • 5 Oncology, SBHI “Leningrad Regional Oncology Dispensary”, 190000 - St. Petersburg/RU
  • 6 Oncology, Asan Medical Center, 05505 - Seoul/KR
  • 7 Oncology, Communal Healthcare Institution Regional Clinical Oncological Center Dept. of Chemotherapy No.1, 61144 - Kharkiv/UA
  • 8 Oncology, Seoul National University Hospital (SNUH)-Yongon Campus, 110-744 - Seoul/KR
  • 9 Oncology, Magodent, Warszawa/PL
  • 10 Oncology, TMC - Tata Medical Centre, 700156 - Kolkata/IN
  • 11 Oncology, Comprehensive Cancer Center Bialostockie Centrum Onkologii, 15-027 - Bialystok/PL
  • 12 Oncology, Saint-Petersburg Scientific and Practical Center of Specialized Methods of Medical Help, Saint-Petersburg/RU
  • 13 Oncology, Lviv State Regional Cancer Treatment and Diagnostic Center, 79031 - Lviv/UA
  • 14 Oncology, St. Luke's Medical Center, 1102 - Quezon City/PH
  • 15 Oncology, N.N.Petrov Research Inst. of Oncology, 197758 - Saint Petersburg/RU
  • 16 Biostatistics, Samsung Bioepis, 16678 - Suwon/KR
  • 17 Clinical Development, Samsung Bioepis, 16678 - Suwon/KR


Abstract 1526


Equivalence for efficacy between SB3 (a proposed trastuzumab biosimilar) and originator trastuzumab (TRZ) in terms of breast pathologic complete response (bpCR) rates has been demonstrated and previously reported.1 Here we present the one-year results on safety, immunogenicity, event-free-survival (EFS), and overall survival (OS).


Study compared neoadjuvant SB3 or TRZ for 8 cycles concurrently with chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil/epirubicin/cyclophosphamide). Patients then underwent surgery followed by 10 cycles of adjuvant SB3 or TRZ as randomised. The primary endpoint was bpCR rate and secondary endpoints included safety, immunogenicity, EFS, and OS up to the adjuvant period.


A total of 875 patients were randomised with a median follow-up duration of 438 days, and 765 patients completed adjuvant therapy (SB3, N = 381; TRZ, N = 384). Incidences of treatment emergent adverse events (TEAEs) were comparable between arms (Table). Most frequently occurring TEAEs were alopecia, neutropenia, and nausea during the neoadjuvant period and radiation skin injury, procedural pain, and fatigue during the adjuvant period. EFS rates were 92.2% in SB3 and 91.6% in TRZ (hazard ratio 0.94; 95% CI, 0.59 to 1.51). There were a total of 6 deaths (SB3, N = 1; TRZ, N = 5). Immunogenicity was low and comparable, with anti-drug antibody positive for 3 patients (0.7%), in each arm.Table:

153PD Safety profile

SB3 N = 437 n, (%)TRZ N = 438 n, (%)
Incidence of TEAEs426 (97.5)421 (96.1)
Grade ≥ 3 TEAEs325 (74.3)315 (71.9)
TEAEs of special interest*48 (11.0)53 (12.1)
Serious TEAEs56 (12.8)58 (13.2)
Death1 (0.2)5 (1.1)

Includes infusion-related reaction, left ventricular systolic dysfunction, and congestive heart failure.


One-year safety, immunogenicity, and survival results further support the biosimilarity established between SB3 and TRZ. Reference: 1. Pivot X et al. ASCO 2017, ID50

Clinical trial identification

EudraCT Number: 2013-004172-35 ClinicalTrials.gov NCT02149524

Legal entity responsible for the study

Samsung Bioepis Co., Ltd.


Samsung Bioepis Co., Ltd.


X. Pivot: Consultant with honorarium for Samsung Bioepis Co., Ltd. L. Younju, J. Lim: Employee of Samsung Bioepis Co., Ltd. Stock ownership of Samsung Biologics. All other authors have declared no conflicts of interest.

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