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

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.

authors

Esteva FJ,Baranau YV,Baryash V,Manikhas A,Moiseyenko V,Dzagnidze G,Zhavrid E,Boliukh D,Stroyakovskiy D,Pikiel J,Eniu AE,Li RK,Rusyn AV,Tiangco B,Lee SJ,Lee SY,Yu SY,Stebbing J

doi

10.1007/s00280-019-03920-4

subject

Has Abstract

pub_date

2019-10-01 00:00:00

pages

839-847

issue

4

eissn

0344-5704

issn

1432-0843

pii

10.1007/s00280-019-03920-4

journal_volume

84

pub_type

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