Biosimilar trastuzumab shown to be similar in efficacy and safety to Herceptin in breast cancer as neoadjuvant and adjuvant treatment

September 11, 2017 1:16 PM

Celltrion Healthcare presents data at the European Society for Medical Oncology (ESMO) 2017 Congress that highlights similarity in efficacy and safety between CT-P6 and Herceptin at both neoadjuvant and adjuvant stages of treatment in patients with HER2-positive early breast cancer (EBC).

The phase 3, double blind, randomised study involving 549 patients with HER2-positive EBC investigated the efficacy and safety of CT-P6 (biosimilar trastuzumab candidate) compared to reference trastuzumab as a pre-operative (neoadjuvant) and post-operative (adjuvant) treatment over the course of one-year’s treatment.

Results from the neoadjuvant stage of the study have previously been published in The Lancet Oncology and revealed that the total pathological complete response (tpCR) rate at surgery was 46.8% for CT-P6 and 50.4% for reference trastuzumab, which are within the predefined equivalence margin.

Data based on the adjuvant treatment period of the study showcased at ESMO 2017, show that the proportion of patients who underwent breast conservation surgery was similar between CT-P6 (22.6%) and reference trastuzumab (20.3%). In addition, new data presented show that similar progressive disease or recurrence rates were observed during both the neoadjuvant and adjuvant treatment period.

CT-P6 was well tolerated and its safety profile through the neoadjuvant and adjuvant period was similar to that of reference trastuzumab. The proportion of patients with at least one serious adverse event was 7.4% for CT-P6 and 11.9% for reference trastuzumab.

Prof. Stebbing, Professor of Cancer Medicine and Oncology, Faculty of Medicine, Department of Surgery & Cancer, Imperial College London said, “Data showing therapeutic comparability between CT-P6 and reference trastuzumab post-surgery is a significant milestone in boosting physician confidence in this biosimilar as it indicates that CT-P6 could provide an effective treatment option for women with early breast cancer and HER2 overexpression both pre and post-operation.”

Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “These data add to the increasing wealth of data supporting CT-P6 as a biosimilar for trastuzumab. They highlight Celltrion’s commitment to delivering affordable medicines through our growing oncology biosimilar portfolio. CT-P6 has already been approved by several countries including the Korean Ministry of Food and Drug Safety and has been submitted to the European Medicines Agency for approval.”

“We have carried out extensive studies between CT-P6 and reference trastuzumab to establish that they are highly similar in physicochemical and biological attributes as well as studies such as this one presented at ESMO 2017 that demonstrate comparability in terms of efficacy and safety.”

Source: Celltrion press release

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