Purpose: This first-in-human study with SB3 was designed to evaluate the pharmacokinetic (PK) equivalence between SB3 and trastuzumab sourced in the European Union (EU trastuzumab), between SB3 and trastuzumab sourced in the United States (US trastuzumab), and between EU and US trastuzumab (NCT02075073).

Methods: In this randomized, double-blind, parallel group, single-dose comparative PK study, 109 healthy male subjects were randomized to receive a single 6-mg/kg IV dose of SB3, EU -trastuzumab, or US trastuzumab. The PK parameters were calculated using noncompartmental methods. The PK equivalence in terms of AUC0--∞), AUC0-last, and Cmax for the pairwise comparisons (SB3 vs EU trastuzumab, SB3 vs US trastuzumab, and EU trastuzumab vs US trastuzumab) were determined using the predefined equivalence margin of 0.8 to 1.25.

Findings: Baseline demographic characteristics for the randomized subjects were similar across the 3 groups. The 90% CIs for the geometric least square means of the AUC0-∞, AUC0-last, and Cmax were completely contained within the margin of 0.8 to 1.25. The proportions of subjects who experienced adverse events related to the study drug were 36.1%, 44.4%, and 61.1% in the SB3, EU trastuzumab, and US trastuzumab groups, respectively. The most frequently reported adverse events related to the study drug was infusion-related reactions. No subjects had positive results for antidrug antibodies after a single dose of SB3, EU trastuzumab, or US trastuzumab.

Implications: This study revealed PK equivalence between SB3 and EU trastuzumab, between SB3 and US trastuzumab, and between EU trastuzumab and US trastuzumab. SB3 is well tolerated without tolerability concerns after single-dose administration in healthy male subjects.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.clinthera.2016.06.002DOI Listing

Publication Analysis

Top Keywords

sb3 trastuzumab
36
trastuzumab trastuzumab
24
trastuzumab
18
trastuzumab sb3
16
sb3
12
healthy male
12
male subjects
12
equivalence sb3
8
trastuzumab sourced
8
dose sb3
8

Similar Publications

Introduction: SB3 is a trastuzumab biosimilar approved in Australia, Brazil, Canada, the European Union, the Republic of Korea, Switzerland, and the USA. This real-world study evaluated safety and effectiveness of SB3 as part of the Korean post approval safety management system.

Methods: This post-marketing surveillance in Korea included patients in line with approved indications, i.

View Article and Find Full Text PDF
Article Synopsis
  • - The study compares the cardiac safety and effectiveness of a trastuzumab biosimilar (SB3) to the original trastuzumab (TRZ) for treating ERBB2-positive breast cancer over a follow-up period of up to 6 years.
  • - Conducted from April 2016 to January 2021, the trial included 538 female patients, with both treatment groups receiving neoadjuvant chemotherapy followed by adjuvant therapy, and monitored for heart-related side effects.
  • - Primary outcomes measured were cardiac issues like heart failure and reduced left ventricular function, with secondary outcomes focusing on event-free and overall survival rates between the two treatment options.
View Article and Find Full Text PDF

Aim: Breast cancer is the most frequently diagnosed cancer in women and ranks second among causes for cancer related death in women. Trastuzumab originator (Herceptin) is a monoclonal antibody used as a standard treatment for breast and metastatic gastric cancer when the cancer cells over-express human epidermal growth factor receptor type 2 (HER2). As the patent of Trastuzumab has now expired, biosimilars are moving into the market.

View Article and Find Full Text PDF

Purpose: Dual blockade with trastuzumab and pertuzumab in combination with chemotherapy is the recommended first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBC). The purpose of this retrospective study is to examine the clinical outcomes of the trastuzumab biosimilar SB3 in first-line dual blockade treatment using real-world data of patients with HER-positive mBC.

Methods: In Denmark, all women with breast cancer are registered in the database of the Danish Breast Cancer Group (DBCG).

View Article and Find Full Text PDF
Article Synopsis
  • The study assessed the safety and effectiveness of the trastuzumab biosimilar SB3 combined with pertuzumab in treating HER2-positive breast cancer patients.
  • Out of 78 participants, 35 received SB3 with pertuzumab and showed a slight decline in heart function, with only 5.7% experiencing significant reductions.
  • Results were promising, as half of the patients treated in the neoadjuvant setting achieved a complete pathological response, indicating that SB3 performs similarly to the standard trastuzumab and pertuzumab combination.
View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!