https://orcid.org/0000-0003-1504-3815
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ABSTRACT
Background
The trastuzumab biosimilar CT-P6 is approved for human epidermal growth factor receptor 2 (HER2)–positive early breast cancer (EBC), metastatic breast cancer (MBC), and metastatic gastric cancer (MGC). The objective of this post-marketing surveillance (PMS) study was to evaluate the real-world safety and effectiveness of CT-P6 in patients with HER2-positive cancers.
Research design and methods
This open-label, observational, prospective, PMS study collected data via investigator surveys from 35 centers in the Republic of Korea (5 October 2018–4 October 2022). Eligible patients with HER2-positive EBC, MBC, or MGC started CT-P6 treatment during routine clinical practice, followed by 1-year observation. Evaluations included adverse events (AEs), adverse drug reactions (ADRs), and effectiveness.
Results
Safety was analyzed in 642 patients (494 EBC, 94 MBC, 54 MGC). Overall, 325 (50.6%) patients experienced 1316 AEs, and 550 ADRs occurred in 199 (31.0%) patients. Unexpected ADRs occurred in 62 (9.7%) patients. Unexpected ADRs and ADRs of special interest did not raise any new safety signals. Among trastuzumab-naïve patients, 34/106 (32.1%) with EBC achieved pathological complete response; 30/74 (40.5%) MBC and 24/49 (49.0%) MGC patients achieved complete or partial response.
Conclusions
In a real-world setting, CT-P6 demonstrated safety and efficacy findings consistent with previous CT-P6 studies.
Declaration of interest
MH Park, JH Seo, JH Park, M-K Seong, KU Park, MK Kim, M Chang, S-J Koh, MH Lee, ST Lim, YB Yoo, SY Oh, and TH Kim have nothing to disclose. SH Kim is an employee of Celltrion, Inc., has a leadership role in Celltrion, Inc., and has stocks for Celltrion, Inc. KY Ahn, TH Park, H Ju, S Kim, N Kim, and E Lee are employees of Celltrion, Inc. and have stocks for Celltrion, Inc. EH Baek is an employee of Celltrion, 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.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Ethics statement
The study was conducted in accordance with the Declaration of Helsinki, with ethical approval obtained from the local institutional review boards at each participating study site (Supplementary Table S1). All participants provided written informed consent.
Author contributions
MH Park, JH Seo, JH Park, M-K Seong, KU Park, MK Kim, M Chang, S-J Koh, MH Lee, ST Lim, YB Yoo, SY Oh, and TH Kim contributed to the data collection and the interpretation of study data. SH Kim, KY Ahn, TH Park, H Ju, and EH Baek contributed to the design of the study and the analysis or interpretation of study data. S Kim, N Kim, and E Lee contributed to the analysis or interpretation of study data. All authors reviewed and critically revised the manuscript, approved the final draft, and are accountable for the accuracy and integrity of the research.
Acknowledgments
We thank all patients and investigators involved in the study. Medical writing support, including development of a draft outline and subsequent drafts in consultation with the authors, collating author comments, copyediting, fact checking, and referencing, was provided by Emma Evans at Aspire Scientific Limited (Bollington, UK). Funding for medical writing support for this article was provided by Celltrion, Inc. (Incheon, Republic of Korea).
Data availability statement
The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/14712598.2024.2334386