Business Wire

Samsung Bioepis Announces Three-year Follow-up Data for Biosimilar ONTRUZANT® (trastuzumab) in Early or Locally Advanced HER2-positive Breast Cancer

Share

Samsung Bioepis Co., Ltd. today announced findings of a three-year follow-up study comparing biosimilar ONTRUZANT® (trastuzumab) and reference medicine trastuzumab in early or locally advanced HER2-positive breast cancer. The data, which show comparable overall survival and cardiac safety, were presented today at the 16th St. Gallen International Breast Cancer Conference 2019 taking place in Vienna, Austria.

“With the development of our biosimilar trastuzumab, we aimed to make one of the mainstays of modern cancer therapy more accessible for more people more quickly, and these long-term data underline the importance of that aim,” said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. “We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges.”

Participants enrolled in an initial Phase III study received eight cycles of the biosimilar trastuzumab or the reference medicine concurrently with chemotherapy in the neoadjuvant setting. Following surgery, they received additional 10 cycles of the biosimilar trastuzumab or the reference medicine. After completion of therapy, 367 of these participants (186 in the biosimilar trastuzumab group and 181 in the reference medicine group) were enrolled in the follow-up study. Median follow-up from initiation of study treatment was 40.8 months in the biosimilar trastuzumab group and 40.5 months in the reference medicine group.

Overall survival was 97% in the biosimilar trastuzumab group and 93.6% in the reference medicine group (HR 0.39, 95% CI, 0.14-1.12). Event-free survival was 92.5% in the biosimilar trastuzumab group and 86.3% in the reference medicine group (HR 0.49, 95% CI, 0.26-0.91). The incidence of cardiac events was rare for both treatment groups throughout the three-year follow-up period. There were three cases of asymptomatic significant left ventricular ejection fraction (LVEF) decrease (biosimilar trastuzumab, n=1; reference medicine, n=2), with all patients recovering with LVEF ≥ 50%. There were no cases of symptomatic congestive heart failure, cardiac death or other significant cardiac conditions reported in either group.

The poster of this study will be exhibited at the 16th St. Gallen International Breast Cancer Conference 2019, as follows:

  • [P156] 3-YEAR FOLLOW-UP OF A PHASE III STUDY COMPARING SB3 (TRASTUZUMB BIOSIMILAR) AND REFERENCE TRASTUZUMAB IN HER2 POSITIVE EARLY OR LOCALLY ADVANCED BREAST CANCER IN NEOADJUVANT SETTING [POSTER SESSION I, MARCH 21, 2019]

ONTRUZANT® (trastuzumab) 150 mg was granted the European Commission (EC) Marketing Authorization in November 2017 and was approved by the U.S. Food and Drug Administration in January 2019. In February 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a 420 mg vial presentation of ONTRUZANT®.iii With the adoption of CHMP’s positive opinion for ONTRUZANT® 420 mg vial presentation, ONTRUZANT® will be available in two vial sizes in Europe, providing clinics with greater convenience and flexibility than the 150 mg vial presentation alone.


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 and ophthalmology. 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 Inc.

ii Pivot, X et al. 2019. 3-year Follow-up of a Phase III Study Comparing SB3 (trastuzumab biosimilar) and Reference Trastuzumab in HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting. St Gallen International Breast Cancer Conference, Vienna, Austria, 20-23 March 2019. [P156 Poster Session I, March 21, 2019]

iii European Medicines Agency – Committee for Medicinal Products for Human Use (CHMP). Final agenda for the meeting on 25-28 February 2019. Available at: https://www.ema.europa.eu/documents/agenda/agenda-chmp-agenda-25-28-february-2019_en.pdf . Last accessed February 2019.

Contact information

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

About 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.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

EURid Launches New Eligibility Criteria19.10.2019 04:30:00 CESTPress release

The top-level internet domain .eu is the eighth largest country code extension on the internet and, as of October 2019, we have more than 3.6 million registrations spread out across Europe. Since its launch in 2006, only companies and individuals residing within the EU and EEA member states have been eligible to register the .eu domain name. However, striving to meet the needs of an ever-changing digital environment, the eligibility criteria for the registration of .eu domain name has now been extended to all EU citizens living around the world. With millions of Europeans living around the world – our hope is to provide these individuals, living far from their native lands, with a personal online platform through which they can share their stories with families and friends back home. “We are excited to be able to extend the registration criteria to EU citizens around the world. The .eu domain is now closer to your ambitions, achievements and dreams. It is the bridge connecting you to y

ams to Launch New Takeover Offer for OSRAM at EUR 41.00 Per Share With Minimum Acceptance Threshold of 55%18.10.2019 17:16:00 CESTPress release

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION (IN WHOLE OR IN PART) IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION ams (SIX: AMS), a leading worldwide supplier of high performance sensor solutions, announces that it intends to launch a new all-cash takeover offer for OSRAM Licht AG ("OSRAM") for 100% of the share capital of OSRAM at a price of EUR 41.00 per share ("Offer"). The Offer which represents a premium of 42% to the undisturbed OSRAM share price of EUR 28.92 as of 2 July 2019 will be launched by ams Offer GmbH, a newly incorporated, wholly owned subsidiary of ams. ams is the largest shareholder in OSRAM with a direct shareholding of 19.99% which ams will not exceed outside of the Offer. As a result of ams' shareholder position, ams has lowered the minimum acceptance threshold to 55%. Winning way forward for ams and OSRAM The combination of ams and OSRAM allows ams to create a global leader in sensor solutio

Resecurity Appoints Selene Giupponi Managing Director of Resecurity Europe18.10.2019 15:38:00 CESTPress release

Resecurity, a cybersecurity company that delivers in-depth analysis layered on top of the most comprehensive, exclusive sets of data from the Deep and Dark Web, announces that Selene Giupponi has joined as Managing Director and will be based in Italy. A digital forensics expert, Selene adds significant value to Resecurity’s operations in Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191018005415/en/ Resecurity Appoints Selene Giupponi Managing Director of Resecurity Europe (Photo: Business Wire) Selene has extensive expertise in digital forensics and is often called as an expert witness regarding digital and mobile forensics on domestic and international cases, investigations and court trials. She is a specialized IT trainer in Italy and teaches digital, mobile, cloud and mainframe forensics, cybercrime and information security at various Italian universities. “Selene brings a depth of experience to our team and we

Secure-24 Completes Acquisition of Symmetry Corporation18.10.2019 14:20:00 CESTPress release

NTT Ltd., the newly formed, world-leading global technology services provider, and Symmetry Holding Inc. (Symmetry), a U.S.-based leading provider of SAP managed services, today announced that Secure-24 Intermediate Holdings, Inc. (Secure-24), part of the Managed Services division of NTT Ltd., has completed the acquisition of Symmetry Corporation effective October 17, 2019. “The powerful business combination of Secure-24 and Symmetry leverages the strengths of both companies around Secure-24’s foundation of delivering managed IT operations, application hosting and cloud services to enterprises worldwide,” said Mike BeDell, Chief Executive Officer, Secure-24. “As we begin to integrate Symmetry’s portfolio into Secure-24’s portfolio, through a shared vision, we look forward to providing even greater value that accelerates our clients’ business success.” Symmetry, headquartered in Brookfield, Wisconsin, will expand the scale of SAP managed services capabilities of Secure-24 and bring new

New Research Reveals Updated Patient Preferences on Digital Health Technology18.10.2019 13:00:00 CESTPress release

ResMed (NYSE: RMD, ASX: RMD) today announced results from a company-led survey, revealing new patient preferences on digital health technology. The survey highlights a reason for optimism that the markets for digital health technology will only continue to grow. The survey of a nationally representative sample of 3,000 Americans, conducted in partnership with Edelman Intelligence, revealed that the use of – and confidence in – remote digital health technology is widespread: 56% of those surveyed currently monitor their health with at least one digital data collection tool. Also, 60% of people attempt to diagnose themselves after browsing symptoms on the Internet – including 76% of Millennials. Perhaps more surprising, remote digital health technology seems to have deepened people’s connection with their physicians rather than distanced them from one another. Over half of those surveyed agree that technology has improved their relationship with their primary care provider, and many woul

CHMP Grants Positive Opinion for Expanded Use of Janssen’s Darzalex®▼(daratumumab) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible18.10.2019 12:43:00 CESTPress release

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Darzalex® (daratumumab) to include the use of daratumumab in combination with lenalidomide and dexamethasone (DRd) for patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). “As multiple myeloma can become more complex with each relapse, it is important that patients receive the latest treatment options with the goal of extending their first remission period,” said Professor Thierry Facon, M.D., Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France, and principal investigator of the MAIA study. “For newly diagnosed patients who are transplant ineligible, this regimen could be an important frontline therapy option and reinforces the consistent clinical profile of daratumuma