INCHEON, Korea – June 1, 2018 - Samsung Bioepis Co., Ltd. today announced additional one-year follow-up study results on SB3, a biosimilar candidate referencing Herceptin®i (trastuzumab). The data was made available as an abstract publication at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting which is being held between June 1-5, 2018 in Chicago.
“The additional one-year follow-up study demonstrates the long-term safety profile of SB3,” said Chul Kim, Head of Clinical Sciences Division, Samsung Bioepis. “We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems can benefit from biosimilars.”
Patients with HER2-positive early breast cancer were randomly assigned to receive eight cycles of SB3 or reference trastuzumab (TRZ) in neoadjuvant setting concurrently with chemotherapy. Patients then underwent surgery, followed by 10 cycles of adjuvant SB3 or TRZ. After completion of therapy, 367 patients (SB3, n=186; TRZ, n=181) 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 (CHF), asymptomatic significant left ventricular ejection fraction (LVEF) decrease, incidence of other cardiac events, event-free survival (EFS), and overall survival (OS).
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.
SB3 is under regulatory review at the US Food and Drug Administration (FDA). The Biologics License Application (BLA) for SB3 was accepted for review in December 2017.
Details on the abstract publication are as follows:
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six late-stage candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.
i Herceptin® is a registered trademark of Genentech.