South Korean biotechnology company Celltrion is starting a phase III clinical trial for its biosimilar trastuzumab candidate (CT-P6) in patients with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer, according to the European Union’s Clinical Trials Register.
CT-P6 is intended to be a biosimilar of Roche’s breast cancer blockbuster Herceptin (trastuzumab). Herceptin is a HER2+ breast cancer therapy designed to treat aggressive HER positive metastatic and adjuvant breast cancer.
The Celltrion study will evaluate the efficacy and safety of the company’s biosimilar trastuzumab (CT-P6) versus Roche’s Herceptin both given in combination with docetaxel followed by FEC (5-fluorouracil, epirubicin and cyclophosphamide) in patients with HER2+ operable early breast cancer.
The trial is a multicentre, double-blind, randomized, active controlled, parallel-group study. The main objective of the study is to demonstrate the equivalent efficacy of CT-P6 and Herceptin (trastuzumab) in patients with HER2+ operable early breast cancer determined by pathological complete response (pCR). The primary efficacy endpoint is defined as the absence of invasive tumour cells in the breast and axillary lymph nodes. The trial will include 532 female patients, aged 18 years and above, with 160 being recruited from 90 sites within the European Economic Area (EEA).
This is a major international trial for Celltrion. The trial is expected to last three years and will include 25 countries across the globe, including Argentina, Belarus, Brazil, Chile, France, Georgia, Greece, Hungary, India, Italy, Korea, Latvia, Mexico, The Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, South Africa, Spain, Ukraine and the US.
Roche’s worldwide sales of Herceptin in 2013 were CHF 6.1 billion (US$6.8 billion) making it a lucrative target for biosimilars manufacturers. Celltrion received approval for its biosimilar monoclonal antibody (mAb) Herzuma (trastuzumab) with the Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration, in January 2014 [1].
Trastuzumab will be Celltrion’s second monoclonal antibody biosimilar. The company gained European approval for the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) as part of its collaboration with US-based generics major Hospira [2]. Celltrion has also gained approval for Remsima in South Korea [3] and Colombia [4], and has also applied for approval in Japan [5].
In anticipation of gaining US approval for its biosimilar of infliximab, Celltrion has also filed a lawsuit in March 2014 in the US District Court of Massachusetts seeking to invalidate certain patents covering Janssen Biotech’s Remicade (infliximab).
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 11]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-approved-in-Korea
2. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 11]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 11]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea
4. GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 11]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia
5. GaBI Online - Generics and Biosimilars Initiative. Celltrion applies for biosimilar infliximab approval in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 11]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-applies-for-biosimilar-infliximab-approval-in-Japan
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Source: EU Clinical Trials Register
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