Business Wire

Samsung Bioepis Announces Results of Additional One-Year Follow-Up Study Comparing Event-Free Survival of SB3 Trastuzumab Biosimilar Candidate to Reference Trastuzumab by ADCC Activity

Del

Samsung Bioepis Co., Ltd. today announced the results of an additional one-year follow-up study comparing event-free survival (EFS) of SB3, a biosimilar candidate referencing HERCEPTIN® 1 (trastuzumab), to reference trastuzumab (TRZ) by antibody-dependent cell-mediated cytotoxicity (ADCC) activity. ADCC is a key mechanism of action for trastuzumab. The study results are being presented at the 2018 San Antonio Breast Cancer Symposium® (SABCS) which is being held December 4-8, 2018 in San Antonio, Texas.

For the study, patients with HER2 positive early or locally advanced breast cancer were randomly assigned to receive SB3 or TRZ concurrently with chemotherapy. Patients then underwent surgery followed by treatment with SB3 or TRZ. Following completion of such therapy, 367 patients participated in a long-term follow-up study, 186 of whom were treated with SB3 and 181 of whom were treated with TRZ. Within the group of 181 patients who received TRZ, 126 patients who were exposed to at least one kit from the TRZ lots with expiry dates between August 2018 and December 2019 during neoadjuvant period were considered "Exposed," while the remaining 55 patients were considered "Unexposed." Upon monitoring the quality attributes of TRZ for the development of SB3, a marked downward shift in ADCC activity was observed in some of the TRZ lots with expiry dates between August 2018 and December 2019.

Following 30.1 months of SB3 treatment and 30.2 months of TRZ treatment, there was no statistically significant difference in EFS between SB3 (96.7%) and the Unexposed arm (98.2%) (HR 1.19, 95% CI 0.23-6.18; p-value=0.8376). However, the results did show statistically significant difference in EFS between the Unexposed (98.2%) and Exposed (92.5%) arms within the TRZ treatment group (HR 0.07, 95% CI 0.01-0.58, p-value=0.0137). In addition, while there was no statistically significant difference in events between SB3 (4.8%) and the Unexposed (3.6%) arms, there was statistically significant difference in events within the TRZ treatment group between the Unexposed (3.6%) and Exposed (10.3%) arms. An event was defined as disease recurrence or progression, or death due to any cause. The study authors are currently looking into longer-term effects of SB3 and hope to publish these results at a later date.

"This study builds on the robust evidence for SB3, and demonstrates the trastuzumab biosimilar candidate's comparable efficacy and safety profiles to the reference biologic over a longer time period," said Chul Kim, Senior Vice President and Head of Clinical Science, Samsung Bioepis. "We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems may be able to benefit from biosimilar medicines."

The poster for this study will be exhibited at SABCS, as follows:

  • [P6-17-09] EVENT-FREE SURVIVAL BY ADCC STATUS FROM A FOLLOW-UP STUDY COMPARING SB3 (TRASTUZUMAB BIOSIMILAR) WITH REFERENCE TRASTUZUMAB FOR HER2 POSITIVE BREAST CANCER IN NEOADJUVANT SETTING [POSTER SESSION 6, December 8, 2018, 07:00AM – 09:00AM]

About Samsung Bioepis Co., Ltd.

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 cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

__________________________

1 HERCEPTIN ® is a registered trademark of Genentech Inc.

Contact information

Mingi Hyun
+82-31-8061-1594
mingi.hyun@samsung.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Tory Burch Names Pierre-Yves Roussel Chief Executive Officer11.12.2018 21:26Pressemelding

Tory Burch, LLC, today announced it has named Pierre-Yves Roussel Chief Executive Officer, starting early 2019. A longtime LVMH executive, Mr. Roussel will be based out of Tory Burch’s New York headquarters; he will join and report to the Company’s board of directors. In partnership with Ms. Burch, he will lead and implement the company’s global strategy with a focus on operations. “There are very few leaders in the industry who have both a commercial track record and a deep admiration for the creative process. I respect what he has built at LVMH and value the way he thinks about business, luxury and the fashion industry as a whole. He also shares my belief in the importance of a culture-led company. We have a strong management team in place and Pierre-Yves is a natural fit as we continue to focus on long-term growth and global expansion,” said Tory Burch, who is currently Chief Executive Officer and will assume the role Executive Chairman and Chief Creative Officer. “I’m very excited

United Nations Climate Action Award Goes to Germany for the First Time11.12.2018 19:00Pressemelding

Within the context of the United Nations Framework Convention on Climate Change, two ProVeg projects were awarded the Momentum for Change Climate Action Award 2018 in the category Planetary Health. One of these is the health promotion project Aktion Pflanzen-Power, jointly initiated with BKK ProVita. ProVeg and its partner received the award for their work in schools. It marks the first time that this award has gone to Germany. The award ceremony took place yesterday in the Polish city of Katowice as part of the 24th UN Climate Change Conference. ProVeg and BKK ProVita promote children’s health and climate action Aktion Pflanzen-Power aims to improve the availability and quality of vegan and vegetarian dishes in schools. Together with BKK ProVita, ProVeg has so far reached 24,800 students at 41 schools throughout Germany on the subject of wholesome, plant-based nutrition as part of the health promotion project. Healthy nutrition with Aktion Pflanzen-Power Andreas Schöfbeck, member of t

Thales and Gemalto are granted regulatory clearance by the European Commission11.12.2018 17:01Pressemelding

Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto announce today that they have been granted merger control Regulatory Clearance by the European Commission, following Thales’s commitment to divest its general purpose hardware security modules (GP HSM) business globally1 to a suitable purchaser. This clearance is effective immediately. Together with the merger control clearances obtained in China, Israel, South Africa and Turkey, and clearances relating to f

Starr Insurance Companies Expands Aviation Insurance Operations to Brazil11.12.2018 15:43Pressemelding

Starr Insurance Companies today announced that Starr International Brasil Seguradora S.A. (“Starr Brazil”) has been granted a local license to offer aviation insurance. “We are thrilled to be adding aviation capability in an important, growing economy like Brazil,” stated Steve Blakey, president and chief executive officer for Starr Insurance Holdings, Inc. “As a worldwide leader in aviation insurance solutions, we are constantly seeking new opportunities and markets to meet the growing needs of the aviation and aerospace industry around the globe.” Fernanda Strachino, aviation specialist underwriter, has joined Starr Brazil to head the new aviation division. Fernanda brings more than 16 years’ of experience in the aviation and insurance market. Starr Brazil will offer a variety of aviation coverages, including: Aircraft Hull & Liability; Spare Parts; Third-Party Legal Liability; Corporate Non-Owned Aircraft Liability; General Liability; RETA Insurance (Mandatory Liability), Hangarkeep

Andersen Global Continues Growth in United Kingdom With Claritas Tax Limited11.12.2018 14:30Pressemelding

Today, Andersen Global expanded its reach in the United Kingdom with the addition of Claritas Tax Limited, a tax advisory and compliance services firm based in Birmingham, the second largest city in the country. Claritas is the fourth firm collaborating with Andersen Global in the UK. “Adding a sought-after firm like Claritas is not only a logical extension for Andersen Global, but it broadens our offering in the UK. Their practice focuses on corporation tax, R&D tax reliefs, mergers and acquisitions, private equity and venture capital in addition to serving individuals,” said Mark Vorsatz, Andersen Global Chairman and Andersen Tax LLC CEO. “Iain Wright and his team enhance our already robust core competences in the UK, a critical market for our clients, and we look forward to working with Claritas on a number of upcoming corporate opportunities.” Founded in 2012, Claritas Tax Limited is an advisory led business that provides a full range of tax advisory and compliance services to entr

Seoul Semiconductor Wins Patent Litigation against Everlight in Germany and Is Awarded Statutory Litigation Costs11.12.2018 14:00Pressemelding

Seoul Semiconductor Co., Ltd. (KOSDAQ:046890) (“Seoul”), a leading global innovator of LED products and technology, announced that it won a patent litigation against Everlight Electronics Co., Ltd. (“Everlight”) in Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181211005233/en/ Seoul Semiconductor's Headquarters in Korea (Photo: Business Wire) The patent involved in this litigation relates to an LED package structure for thermal dissipation. Everlight purchased this patent from a U.S. company in 2017, and subsequently brought a patent lawsuit against Seoul in the Manheim Court of Germany. In December 2018, however, the Manheim Court ruled in favor of Seoul and ordered that Everlight, as the losing party, should bear the statutory costs of the court proceeding. In the United Kingdom, Seoul had already won a patent litigation against Everlight earlier this year. At that time, the UK Patent Court also ordered that Ever