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Open Access 01-10-2019 | Breast Cancer | Original Article

Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial

Authors: F. J. Esteva, Y. V. Baranau, V. Baryash, A. Manikhas, V. Moiseyenko, G. Dzagnidze, E. Zhavrid, D. Boliukh, D. Stroyakovskiy, J. Pikiel, A. E. Eniu, R. K. Li, A. V. Rusyn, B. Tiangco, S. J. Lee, S. Young Lee, S. Y. Yu, J. Stebbing

Published in: Cancer Chemotherapy and Pharmacology | Issue 4/2019

Abstract

Purpose

Neoadjuvant CT-P6, a trastuzumab biosimilar, demonstrated equivalent efficacy to reference trastuzumab in a phase 3 trial of HER2-positive early-stage breast cancer (EBC) (NCT02162667). We report post hoc analyses evaluating pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures.

Methods

Following neoadjuvant treatment and surgery, patients received adjuvant CT-P6 or trastuzumab (6 mg/kg) every 3 weeks for ≤ 1 year.

Results

In total, 271 and 278 patients received CT-P6 and trastuzumab, respectively. pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage. Overall, 47.6% (CT-P6) and 52.2% (trastuzumab) of patients experienced study drug-related treatment-emergent adverse events (TEAEs), including 17 patients reporting heart failure (CT-P6: 10; trastuzumab: 7). Two CT-P6 and three trastuzumab patients discontinued adjuvant treatment due to TEAEs.

Conclusion

Adjuvant CT-P6 demonstrated comparable efficacy and safety to trastuzumab at 1 year in patients with HER2-positive EBC, supporting CT-P6 and trastuzumab comparability.

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Title: Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial
Authors: F. J. Esteva
Y. V. Baranau
V. Baryash
A. Manikhas
V. Moiseyenko
G. Dzagnidze
E. Zhavrid
D. Boliukh
D. Stroyakovskiy
J. Pikiel
A. E. Eniu
R. K. Li
A. V. Rusyn
B. Tiangco
S. J. Lee
S. Young Lee
S. Y. Yu
J. Stebbing
Publication date: 01-10-2019
Publisher: Springer Berlin Heidelberg
Keywords: Breast Cancer
Breast Cancer
Trastuzumab
Published in: Cancer Chemotherapy and Pharmacology / Issue 4/2019
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-019-03920-4

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