Celltrion Healthcare: The Lancet Oncology publishes Data-Set from phase 3 neoadjuvant trial of biosimilar trastuzumab candidate, CT-P6, in patients wi
Data show that CT-P6 is comparable to reference trastuzumab in terms of efficacy and safety
Tuesday, June 14 2017. Detailed results from the phase 3, double-blind, randomised, parallel-group, active-controlled study of biosimilar trastuzumab candidate, CT-P6, were published in The Lancet Oncology.[1]
The study involved 549 patients with HER2-positive, operable, early stage breast cancer, and explored the clinical equivalence and comparability between CT-P6 and reference trastuzumab in neoadjuvant treatment of HER2-positive early-stage breast cancer. The results demonstrate that CT-P6 has equivalent efficacy and similar safety profile to those of reference trastuzumab.
Following the publication at The Lancet Oncology, the finding from the study revealed that both of the risk ratio estimate (required for the US Food and Drug Administration) and the treatment outcome difference (required for the European Medicines Agency) for the pathological complete response (pCR) of CT-P6 and reference trastuzumab fell within the pre-specified equivalence margin. Other efficacy endpoints such as overall response consistently supported the findings. Overall safety profiles were similar between two groups, with the proportion of patients with at least one serious adverse event being 7% for CT-P6 and 8% for reference trastuzumab. The study also reported similar pharmacokinetics and pharmacodynamics between CT-P6 and reference trastuzumab.
“The Lancet Oncology publication has provided convincing clinical evidence for the similarities of the two products,” said Dr Kwon, Head of Medical Affairs at Celltrion Healthcare, “A cost-effective treatment option like biosimilar trastuzumab could help to decrease the burden on healthcare systems worldwide and increase access to the targeted therapy for HER2-positive breast cancer patients”.
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 The Lancet Oncology
The Lancet Oncology is the world-leading clinical oncology periodical publishing high-quality, peer-reviewed research, reviews, comment and opinion, weekly news, and Commissions. The journal covers international issues relevant to clinical cancer specialists worldwide. The Lancet Oncology has an Impact Factor of 26.509.
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 FDA cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/
[1] 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, 2017. doi:10.1016/s1470-2045(17)30434-5.