Business Wire

Biosimilar trastuzumab candidate, CT-P6, shown to be similar in efficacy and safety to the reference trastuzumab

Jaa

Data presented at the 2017 American Society of Clinical Oncology Annual Meeting has shown similarity in efficacy and safety between CT-P6 (biosimilar trastuzumab candidate) and reference trastuzumab as pre-operative (neoadjuvant) treatment in patients with early breast cancer (EBC) and HER2 overexpression.1

The phase 3, double-blind, randomised, parallel-group study investigated the efficacy and safety of CT-P6 compared to reference trastuzumab as a neoadjuvant treatment in HER2-positive EBC. After surgery, patients received CT-P6 or the reference trastuzumab to complete a total of one year of treatment.1

The primary endpoint was pathological complete response (pCR) rate at surgery. The total pCR rate was 46.8% for CT-P6 and 50.4% for reference trastuzumab in the pre-protocol set (PPS) with the 95% confidence intervals for the risk ratio estimates within the equivalence margin in both the PPS and intent to treat (ITT) set analyses.1

Secondary endpoints were overall response rate, pharmacokinetics, pharmacodynamics and safety. All secondary efficacy endpoints were shown to be similar between CT-P6 and reference trastuzumab. The serum concentrations of trastuzumab were similar between both groups during the neoadjuvant period. Additionally, the HER2 shed antigen level decreased from baseline and was similar between the two treatment groups during the neoadjuvant period. 1

CT-P6 was well tolerated with a similar safety profile to that of reference trastuzumab during the neoadjuvant period. The proportion of patients with at least one treatment-emergent serious adverse event was 6.6% for CT-P6 and 7.6% for reference trastuzumab. 1

Further information about the study will be published in The Lancet Oncology shortly.

“It’s encouraging to see that these data show the comparability between CT-P6 and the reference trastuzumab and that we were able to demonstrate therapeutic equivalence between the two,” said Prof Stebbing, first author of The Lancet Oncology fast track publication and Professor of Cancer Medicine and Oncology, Faculty of Medicine, Department of Surgery & Cancer, Imperial College London, “With the costs of oncology treatments being so burdensome, high quality treatments at reduced prices could be of huge benefit to health systems worldwide”.

The study adds to an increasing wealth of data available for biosimilars in oncology. CT-P6, a biosimilar candidate of Herceptin, is the second product in Celltrion’s oncological biosimilar portfolio, which has been submitted to the EMA for product approval in all indications of the reference trastuzumab including HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

“Biosimilars are becoming more and more widely accepted within the medical community and we look forward to working with the relevant regulatory bodies to make our third biosimilar available to patients around the world,” said Dr Kwon, Head of Medical Affairs at Celltrion Healthcare.

--- Ends---

Notes to editors:

About CT-P6 (biosimilar trastuzumab candidate)

CT-P6 is a monoclonal antibody (mAb) – a protein designed to recognise and bind to a specific structure or antigen in the body. CT-P6 has been designed to bind with high affinity and specificity to the extracellular domain of human epithelial growth factor receptor (HER2).

HER2 is found to be overexpressed and/or amplified in about 15-20% of patients with the diseases for which reference trastuzumab is indicated. By binding to HER2 receptor binding domains on the tumor cells, trastuzumab inhibits proliferation of HER2 overexpressing tumour cells.

Celltrion has carried out extensive studies between CT-P6 and reference trastuzumab to establish that they are highly similar in physicochemical and biological attributes. Studies have also demonstrated comparability in terms of efficacy, pharmacokinetic, pharmacodynamic, immunogenicity and safety.

About Celltrion Healthcare

Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/

1 Stebbing, Justin et al. Double-blind, randomized phase III study to compare the efficacy and safety of CT-P6, trastuzumab biosimilar candidate versus trastuzumab as neoadjuvant treatment in HER2 positive early breast cancer (EBC). American Society of Clinical Oncology. 2017. 510

Contact information

Celltrion Healthcare
Emma Gorton
egorton@hanovercomms.com
+44 203 817 6591
or
Anna Reilly
areilly@hanovercomms.com
+44 203 817 6586

Tietoja julkaisijasta

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

Pat Johnson Joins UniPrint Team in Europe19.7.2018 10:35Tiedote

UniPrint.net announced today that Pat Johnson has joined the company to support and develop their EMEA Partner Program, as well as with the promotion of their highly successful Cloud solutions UniPrint Infinity™ and ePRINTit™. Pat brings with him 20 years of experience at Xerox UK where he was instrumental in engaging with software vendors to support Xerox Connectkey products and Xerox Business Partner Channels. In joining UniPrint.net, Pat is well placed to support the continued growth of UniPrint.net EMEA Partners with the UniPrint product portfolio. Pat will hold the new position of MPS Partner & Strategy Manager EMEA, continuing UniPrint’s success in engaging valued business partners towards a modern approach for Software as a Service (SaaS) and Cloud printing solutions. Pat comments: “I am excited to start a new challenge within UniPrint.net and I look forward to working with the EMEA team to further develop their Partner Program. I am fortunate to be joining a respected company w

The Poseidon Foundation: Liverpool Bids to Be First ‘Climate Positive’ City by End of 202019.7.2018 10:34Tiedote

The Poseidon Foundation (“Poseidon”) have signed a ground-breaking partnership with Liverpool City Council in a bid to make Liverpool the world’s first climate positive city by the end of 2020. The city council has signed an agreement with Poseidon to integrate its ground-breaking blockchain-powered platform into Liverpool’s day to day operations. Poseidon’s technology offsets the carbon impact of any product or service by transparently supporting essential forest conservation projects, allowing individuals, organisations and governments to reverse the impact of climate change every day through their activities. Poseidon will be moving its operations to the city in order to play a key role in Liverpool’s new climate positive strategy, which will be trialled over the next 12 months. Poseidon, who are already working closely with Liverpool company BAC Mono to create the world’ first climate positive car, will work with local schools, universities and businesses to develop educational pro

Elliott Advisors (UK) Statement on thyssenkrupp AG19.7.2018 10:30Tiedote

Funds advised by Elliott Advisors (UK) Limited (“Elliott”) are significant shareholders in thyssenkrupp AG (“thyssenkrupp” or the “Company”). Elliott notes recent press coverage referencing the contents of a private letter Elliott sent to the thyssenkrupp Supervisory Board yesterday morning. In order to avoid any misunderstandings or misrepresentations of its substance, Elliott is hereby making the full text of the letter public. *** The Members of the Supervisory Board thyssenkrupp AG thyssenkrupp Allee 1 45143 Essen 18 July 2018 Ladies and Gentlemen, We note the resignation of Professor Dr. Ulrich Lehner as chairman of the Supervisory Board of thyssenkrupp AG. When we met with Professor Lehner in Essen on 27th June he and we assured each other of our desire to develop a constructive working relationship. Professor Lehner’s comments in the interview he gave to Die Zeit on 12th July suggest that he did not give those assurances in good faith. In the course of the interview with Die Zei

Albar Capital Deploys FlexNOW19.7.2018 10:30Tiedote

FlexTrade (@FlexTrade) today announced that Albar Capital Ltd., a new hedge fund led by Javier Velazquez (formerly of Millennium Capital Partners LLP), is now trading equities and futures using FlexNOW, FlexTrade’s new execution management system. “The FlexNOW team was instrumental in solving several of our problems,” said Jason Ruder, Trader at Albar Capital. “Not only are they helping us with our compliance requirements, they are also responsive to requests that improve my workflow.” According to Rhyd Lewis, FlexNOW Product Manager, FlexNOW’s quick onboarding and easy installation process was critical for Albar Capital’s launch on 2 July. “We had no problem integrating FlexNOW with Albar’s portfolio and risk management platform, Paladyne, which allows Fund Managers to route orders to the dealing desk,” said Lewis. “Additionally, Albar has connectivity to their executing venues via FlexTrade’s zero-touch broker network.” Multi-Asset, MiFID II Compliant Trading Designed to handle tradi

Entersekt Signs on to Mobile Connect19.7.2018 10:00Tiedote

Entersekt, an innovator in mobile-first fintech solutions, today announced it has signed an agreement with the GSMA to offer Mobile Connect to its institutional customers. Developed by the mobile industry as a universal mobile-device–based authentication service, Mobile Connect allows consumers across the globe to access their digital accounts via a single login. Users of the service do not have to remember multiple usernames and passwords. Instead, they identify themselves with their unique mobile number, together with a second factor like a PIN or biometric scan when additional security is required. Entersekt already offers advanced authentication and app security solutions, but the company believes Mobile Connect could help it address several increasingly urgent challenges banks face in streamlining customer-facing digital interactions. The service can facilitate the sharing with digital service providers of mobile-operator–held user and device data – and it is contextual informatio

Login VSI Revolutionizes Application Compatibility Testing19.7.2018 09:35Tiedote

Today software solution provider Login VSI (www.loginvsi.com), the industry leader in VDI and DaaS performance and availability testing, announced its newest solution: Login AT for Application Compatibility Testing. Large organizations typically have numerous applications running on their Microsoft Windows platform. Quality-driven organizations require a compatibility test for every application after every upgrade, update or other change in their relevant infrastructure. The growing flow of changes increases the need for application compatibility testing. This flow includes Operating System migrations, updates and patch releases (intensified by Windows 10), but also hardware changes, configuration changes, firmware revisions, database or data center migrations, server memory upgrades and security patches such as for Meltdown and Spectre. To cope with the huge challenge of keeping all applications working after every change, organizations have had to rely on costly internal or outsource

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