Samsung Bioepis Announces Results of Additional One-Year Follow-up Study on SB3 Trastuzumab Biosimilar Candidate at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting
Samsung Bioepis Co., Ltd. today announced additional one-year follow-up study results on SB3, a biosimilar candidate referencing Herceptin® 1 (trastuzumab). The data was made available as an abstract publication at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 1-5, 2018 in Chicago.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180601005020/en/
Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)
“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 by 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:
‘Additional one-year follow-up study to evaluate safety and survival
in patients who have completed neoadjuvant-adjuvant treatment with SB3
(trastuzumab biosimilar) or reference trastuzumab in HER2-positive
early or locally advanced breast cancer’
- Abstract Number: e12631
- Lead Author: Xavier Pivot
- URL: https://meetinglibrary.asco.org/record/163029/abstract
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 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.
1 Herceptin ® is a registered trademark of Genentech
Samsung Bioepis Co., Ltd.
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Loxam Announces the Acquisition of Italian Powered Access Rental Specialist Nove22.6.2018 10:00 | Tiedote
Loxam Group (“Loxam”) announces the acquisition of the Italian powered access rental company No.Ve. S.r.l. (“Nove”) from Haulotte Group S.A. (“Haulotte”). Nove was founded in 1998 and was controlled by Haulotte since 2006. The company is headquartered in Rome and has 45 employees in 6 branches throughout Italy. Following the acquisition of Nacanco last year, this transaction enables Loxam to consolidate its leading position in the Italian powered access rental market. Gérard Déprez, President of Loxam states: “I am delighted to welcome the skilled and experienced Nove team into the Loxam group. Nove is a long-established player in Italy and operates an equipment range very well known to the Loxam Group and we will be able to share our mutual expertise. We will join forces to provide our customers with the best service through an expanded network, and build a reference company in the Italian equipment rental market.” “The divestment of Nove is in line with Haulotte strategic targets and
Wealthify Selects Moody’s Analytics Modeling Technology to Support Its Online Investment Proposition22.6.2018 10:00 | Tiedote
Moody’s Analytics, a leading provider of financial intelligence, announced today that its technology has been selected by Wealthify, an innovative provider of digital wealth management services. Wealthify will be using the Moody’s Analytics Wealth Scenario Generator (“WSG”) to assist clients in making informed decisions on their investment plans. The Moody’s Analytics WSG is a modeling engine that supports financial planning and investment decision making. It has been integrated into Wealthify’s online investment proposition to illustrate a likely range of financial outcomes based on the investment style and level of investment a customer selects. This allows investors to better appreciate the balance between risk and return. “Our decision to work with Moody’s Analytics was driven by their comprehensive modeling and technology offering,” said Michelle Pearce, co-founder and Chief Investment Officer at Wealthify. “Their solution provides the robust economic assumptions required for our
OpenGate Capital Completes Sale of NorPaper Group to Gemayel Freres & Chaoui Industriel Group22.6.2018 09:00 | Tiedote
OpenGate Capital, a global private equity firm, announced today that it has completed the sale of one of its legacy, pre-fund investments, NorPaper Group (“NorPaper”), to Gemayel Freres & Chaoui Industriel Group, a Lebanon-based business specialized in recycled corrugated cardboard and packaging products. Terms of the transaction were not disclosed. OpenGate Capital acquired NorPaper from Canadian paper conglomerate, Cascades, in 2011. NorPaper is a leading producer of white top testliner paper that is sold to European packaging manufacturers. Realizing an opportunity to increase capacity within NorPaper, OpenGate completed an accretive, add-on acquisition in February of 2015 of DS Smith Packaging Papeterie de Nantes SAS (“Nantes”), a division of DS Smith, Plc (LON: SMDS). Integrated into NorPaper, Nantes broadened the product portfolio and added 50kT per year of production capacity through its white top testliner paper made from 100% recycled fiber with best in class quality and print
First Westinghouse AP1000® Nuclear Plant Sanmen 1 Completes Initial Criticality21.6.2018 23:24 | Tiedote
Westinghouse Electric Company, China State Nuclear Power Technology Corporation (SNPTC) announced today that the world’s first AP1000 nuclear power plant located in Sanmen, Zhejiang Province, China has successfully completed initial criticality. “Today we completed the final major milestone before commercial operation for Westinghouse’s AP1000 nuclear power plant technology,” said José Emeterio Gutiérrez, Westinghouse president and chief executive officer. “We are one step closer to delivering the world’s first AP1000 plant to our customer and the world – with our customers, we will provide our customers in China with safe, reliable and clean energy from Sanmen 1.” Following initial criticality will be connection to the electrical grid. Once plant operations begin at Sanmen 1, it will be the first AP1000 nuclear power plant in operation, offering innovative passive safety system technology, multiple layers of defense and advanced controls for unequaled reliability and safety. Commentin
Westinghouse Loads Fuel in Second AP1000® Nuclear Power Plant21.6.2018 23:07 | Tiedote
Westinghouse Electric Company and its customers, China State Nuclear Power Technology Corporation (SNPTC) and Shangdong Nuclear Power Company Limited (SDNPC) announced today that Haiyang Unit 1, the AP1000 nuclear power plant located in Haiyang, Shandong Province, China, has begun to load fuel. “This is a great day for Westinghouse, our China partners and the nuclear industry. Haiyang Unit 1 continues to demonstrate our ability to deliver safe, innovative solutions for power generation,” said José Emeterio Gutiérrez, Westinghouse president and chief executive officer. He added, “Westinghouse will continue to deploy AP1000 technology throughout the world and demonstrate our technical leadership in the nuclear energy industry.” Fuel load at Haiyang Unit 1 commenced at 7:36 p.m. (GMT+8) today. Earlier this summer, in preparation for fuel load, Haiyang Unit 1 successfully completed the necessary testing and regulatory reviews conducted by China’s National Nuclear Safety Administration (NNS
Pharnext to Announce Top-Line Results from the Pivotal Phase 3 Trial of PXT3003 for the Treatment of Charcot-Marie-Tooth Type 1A Disease by October 201821.6.2018 21:23 | Tiedote
Regulatory News: Pharnext SA (Paris:ALPHA) (FR0011191287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drug combinations based on big data genomics and artificial intelligence, today announced an update from its ongoing Phase 3 clinical program (PLEO-CMT and PLEO-CMT-FU studies) evaluating PXT3003 for the treatment of Charcot-Marie-Tooth type 1A disease (CMT1A) in adults. Top-line results from the pivotal PLEO-CMT study are now expected by October 2018. Prof. Daniel Cohen, M.D., Ph.D., Pharnext’s Co-Founder and Chief Executive Officer said: “We are thrilled to bring this Phase 3 clinical trial to completion and we now expect to disclose top-line results by October of this year. Our PLEODRUG™ PXT3003 has already shown initial signals of efficacy in our Phase 2 trial in CMT1A. We are hopeful we can bring this much-needed therapy to patients suffering from this debilitating condition, as they currently have limited therapeutic options, mo
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme