Long‑Term Safety and Efectiveness of PF‑05280014 (a Trastuzumab Biosimilar) Treatment in Patients with HER2‑Positive Metastatic Breast cancer: Updated Results of a Randomized, Double‑Blind Study

Li, R.K. and Tokunaga, E. and Adamchuk, H. and Vladimirov, V. and Yanez, E. and Lee, K.S. and Bondarenko, I. and Vana, A. and Hilton, F. and Ishikawa, T. and Tajima, K. and Lipatov, O. (2022) Long‑Term Safety and Efectiveness of PF‑05280014 (a Trastuzumab Biosimilar) Treatment in Patients with HER2‑Positive Metastatic Breast cancer: Updated Results of a Randomized, Double‑Blind Study. BioDrugs, 36. pp. 55-69. ISSN 1173-8804 (Print) 1179-190X (Online)

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Abstract

Background PF-05280014 was compared with trastuzumab sourced from the European Union (trastuzumab-EU), each plus paclitaxel, as frst-line treatment for human epidermal growth factor receptor 2-positive metastatic breast cancer in a phase III study. Equivalence between treatment groups was demonstrated. Objective The aim of this study was to report long-term safety and overall survival (OS) over 6 years after the frst patient was screened. Patients and methods Randomized patients received intravenous PF-05280014 or trastuzumab-EU, each plus paclitaxel, until objective disease progression. OS, long-term safety, subgroup safety (patients ongoing after day 378), and time-totreatment discontinuation (TTD) were assessed based on the fnal statistical analysis plan amended for the ad-hoc analyses. Results Of 707 randomized patients (n = 352, PF-05280014; n = 355, trastuzumab-EU), 252 (71.6%) in the PF-05280014 and 251 (70.7%) in the trastuzumab-EU group discontinued treatment due to objective progression. Overall, 451 (63.8%) patients completed the study. Between groups (PF-05280014; trastuzumab-EU), estimated median TTDs were 12.25 and 12.06 months (p = 0.692); 61 (17.3%) and 67 (18.9%) patients died; stratifed hazard ratio for OS was 0.929 (95% confdence interval 0.656–1.316; p = 0.339); estimated survival rates were 82.3 and 77.4% at 2 years and 77.2 and 75.3% at 3 years. The incidences of treatment-emergent adverse events (TEAEs) overall (98.6%; 96.6%) and for grades ≥3 (41.0%; 43.1%) were comparable between groups. In patients (n = 265; n = 264) ongoing after day 378, the incidences of any TEAEs, grade ≥3 TEAEs, and serious TEAEs were comparable between the treatment groups. Conclusion Long-term safety and OS were consistent with previous results and demonstrated no clinically meaningful differences between treatment groups. Trial registration ClinicalTrials.gov: NCT01989676 (21 November 2013); and EudraCT: 2013-001352-34 (18 December 2013).

Item Type:	Article
Subjects:	Oncology
Divisions:	Departments > Department of Oncology and Medical Radiology
Depositing User:	Елена Шрамко
Date Deposited:	16 Mar 2022 12:54
Last Modified:	16 Mar 2022 12:54
URI:	http://repo.dma.dp.ua/id/eprint/7389

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