Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study

Hans-Christian Kolberg (), Marco Colleoni, Georgia Savva Demetriou, Patricia Santi, Hans Tesch, Yasuhiro Fujiwara, Zorica Tomasevic and Vladimir Hanes
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Hans-Christian Kolberg: Marienhospital Bottrop gGmbH
Marco Colleoni: IEO, European Institute of Oncology, IRCCS
Georgia Savva Demetriou: University of Witwatersrand
Patricia Santi: Centro de Estudos de Hematologia e Oncologia
Hans Tesch: Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Yasuhiro Fujiwara: National Cancer Center Hospital
Zorica Tomasevic: Institute for Oncology and Radiology of Serbia
Vladimir Hanes: Amgen Inc

Drug Safety, 2020, vol. 43, issue 3, No 4, 233-242

Abstract: Abstract Introduction Although the human epidermal growth factor receptor 2 (HER2) blocker trastuzumab is generally well tolerated, cardiotoxicity can be an important therapeutic limitation. Objective In this prespecified analysis, we compared the cardiac safety of the trastuzumab biosimilar ABP 980 (KANJINTI™) and the trastuzumab reference product (RP; Herceptin®) in the phase III LILAC study (ClinicalTrials.gov identifier NCT01901146). Methods In the neoadjuvant phase of LILAC, after run-in chemotherapy, 725 patients were randomized 1:1 to ABP 980 (n = 364) or trastuzumab RP (n = 361) plus paclitaxel (every 3 weeks [Q3W] or every week [QW]) for four cycles. After surgery, patients continued treatment Q3W for up to 1 year; ABP 980-treated patients continued ABP 980 (ABP 980/ABP 980; n = 364), and trastuzumab RP-treated patients either continued on the RP (trastuzumab RP/trastuzumab RP; n = 190) or switched to ABP 980 (trastuzumab RP/ABP 980; n = 171). Cardiac safety was monitored by computerized 12-lead electrocardiogram, and left ventricular ejection fraction (LVEF) was assessed by two-dimensional (2D) echocardiogram. LVEF decline was defined as LVEF value decrease from study baseline by ≥ 10 percentage points and to

Date: 2020
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DOI: 10.1007/s40264-019-00886-3

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