Real-world clinical scenarios during introduction of trastuzumab biosimilar for HER2-positive breast cancer in the European Union

Abstract

Aim: Trastuzumab-anns is an intravenously administered biosimilar to trastuzumab approved by the EMA and US FDA for treatment of HER2+ early and metastatic breast cancer as well as metastatic gastric cancer. Lack of real-world characterization of biosimilar use has hindered uptake. Methods: This observational chart review characterizes 488 patients who received trastuzumab-anns in EU clinical practice settings. Results: Approximately 2/3rds of patients initiated trastuzumab-anns in adjuvant and neoadjuvant settings and most were naive new starters (70%). 30% were switchers from another trastuzumab, among whom 48% switched from trastuzumab iv. reference product. Common reasons for trastuzumab-anns discontinuation were a switch to another biosimilar product (34.8%, n = 85) or to trastuzumab reference product (15.6%, n = 38). Conclusion: Trastuzumab-anns was widely used in various treatment settings for HER2+ breast cancer.

Plain language summary

Some patients have a type of breast cancer caused by abnormal amounts of a normal growth factor receptor. This growth factor receptor, known as human epidermal growth factor receptor-2 (HER-2), plays a role in normal life changes that occur in breast tissue, including during pregnancy. HER-2 exists on the surface of breast cells and sends a signal inside cells for growth and proliferation. Sometimes an abnormal amount of HER-2 appears on breast cell surfaces, which causes HER-2 to promote excessive growth and proliferation and leads to HER2+ breast cancer. HER2+ breast cancer can be treated with trastuzumab, a medicine that specifically blocks HER-2 signals, and stops cancer cell growth. Trastuzumab has greatly improved outcomes for women worldwide with HER2+ breast cancer but trastuzumab is not always available due, in part, to its high cost. Biosimilars are medicines that are highly similar, but not identical, to the brand name (original) product and have been shown in clinical trials to result in no meaningful difference in efficacy and safety compared with the original product. Trastuzumab-anns is an intravenously administered biosimilar to trastuzumab. Biosimilars are as effective and safe as original products, although more cost-effective, such that physicians and patients can benefit from more information about their use in the real world. This study provided information about trastuzumab-anns use from clinical oncology practices in seven European countries. The study provides real world evidence that trastuzumab-anns is used widely across different patients with HER2+ breast cancer, including those with metastatic disease.

Keywords: :

• adjuvant
• biosimilar
• HER2-positive breast cancer
• metastatic
• neoadjuvant
• observational
• real-world
• retrospective
• systemic therapy
• trastuzumab-anns

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/fon-2023-0421

Author contributions

All the authors were involved in the design and/or conduct of the study. All authors have contributed to the preparation and writing of the manuscript and approved the final manuscript.

Acknowledgments

T Harrison and C Aulet of Amgen Inc. provided operational planning assistance.

Financial disclosure

This study was funded by Amgen Inc. S Lewis is an employee and stockholder for Amgen Inc. D Sandschafer is an employee, stockholder and provides expert testimony for Amgen Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

L Wyrwicz is a speaker and advisor for Amgen Inc. CA Rodríguez Sánchez is a speaker for Amgen Inc. T San is a consultant for Novartis and Eisai. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing disclosure

K Miles of BioScience Communications, New York, NY, provided medical writing support (funded by Amgen Inc.).

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations.

Data sharing statement

Qualified researchers may request data from Amgen clinical studies. Complete details are available at the following: www.amgen.com/science/clinical-trials/clinical-data-transparency-practices/clinical-trial-data-sharing-request.

Previous presentation

Poster presented at European Society for Medical Oncology; Paris, France; 9–13 September 2022 [32].

Open access

This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/