5 June 2018 - - Seoul, Korea-based biopharmaceutical company Samsung Bioepsis has released additional one-year follow-up study results on SB3, a biosimilar candidate referencing Herceptin 1 (trastuzumab or TRZ), the company said.
Patients with human epidermal growth factor receptor 2 -positive early breast cancer participated in the study. After completion of therapy, 367 patients consented to participate in a five-year follow-up study. The median follow-up duration from initiation of study treatment was 30.1 months in SB3 and 30.2 months in TRZ.
The aim of this study was to observe the incidence of symptomatic congestive heart failure, asymptomatic significant left ventricular ejection fraction decrease, incidence of other cardiac events, event-free survival, and overall survival.
Throughout the additional one-year treatment-free follow-up period, the study results showed low incidence of cardiac safety events and no statistically significant difference in survival results compared to TRZ in the SB3 treatment group.
Samsung Bioepis is focused on increasing patient access to high-quality medicines by advancing a broad pipeline of biosimilar candidates that includes six late-stage candidates covering the therapeutic areas of immunology, oncology and diabetes.