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Biosimilar trastuzumab candidate, CT-P6, shown to be similar in pharmacokinetics to the reference trastuzumab in HER2 positive early breast cancer pat

등록일 2018-06-02

Biosimilar trastuzumab candidate, CT-P6, shown to be similar in pharmacokinetics to the reference trastuzumab in HER2 positive early breast cancer patients 


 

2 June 2018, Chicago, USA Data presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting has shown similarity in pharmacokinetics (PK) between CT-P6 (biosimilar trastuzumab candidate) and reference trastuzumab as pre-operative (neoadjuvant) treatment in patients with HER2 positive early-stage breast cancer (EBC) undergoing chemotherapy.[i]


The phase 3, double-blind, randomized study involving 549 patients with HER2-positive EBC patients previously demonstrated that CT-P6 is comparable to reference trastuzumab in terms of efficacy and safety. The primary endpoint was pathological complete response (pCR) which revealed that CT-P6 and reference trastuzumab were within predefined equivalence margin.[ii]

In additional subgroup PK analysis showcased at ASCO Annual Meeting (abstract No# 591) showed that the serum CtroughSS levels and key PK parameters of trastuzumab were comparable between CT-P6 and reference trastuzumab groups. This data support the PK similarity between CT-P6 and reference trastuzumab independently of patients characteristics.

“Such trial data as this PK subgroup analysis is an important addition to the robust body of evidence demonstrating comparability between CT-P6 and reference trastuzumab in early breast cancer patients,” said Prof Stebbing, Professor of Cancer Medicine and Oncology, Faculty of Medicine, Department of Surgery & Cancer, Imperial College London as well as editor-in-chief of Oncogene Journal, “With the costs of oncology treatments being so burdensome, high quality treatments at reduced prices could be a huge benefit to health systems worldwide.”

“We are excited to reveal updated results of CT-P6 phase 3 equivalence trial as it once again supports the established comparable efficacy and safety, profile of CT-P6 with reference trastuzumab in patients with early breast cancer” said Dr. Suliman Boulos MD, Medical Director at Celltrion Healthcare. “Celltrion Healthcare is fully committed to continue the accumulation of data that support the efficacy and safety of CT-P6 and bring these forward to help professionals and patients.”

 

 

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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/


 

[i] Stebbing, Justin et al. Pharmacokinetics of CT-P6 and Reference Trastuzumab by Clinical Factors in Patients with HER2 Positive Early-Stage Breast Cancer (EBC). American Society of Clinical Oncology. 2018. 591

[ii] Stebbing et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled phase 3 equivalence trial. The Lancet Oncology. (18:7) p917–928. July 2017. Available at http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30434-5/fulltext. [Last accessed May 2018.]