Positive phase III results for Amgen’s trastuzumab biosimilar

Biosimilars/Research | Posted 26/08/2016 post-comment0 Post your comment

Results of a study of Amgen and Allergen’s trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab) have ‘ruled out inferiority’, according to the company.

Trastuzumab Herceptin V13D12

The phase III trial evaluated the efficacy and safety of ABP 980 compared to Herceptin in patients with human epidermal growth factor receptor 2-positive early breast cancer.

The results, according to Amgen, ‘ruled out inferiority compared to trastuzumab but could not rule out superiority based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response (pCR)’, which was defined by the absence of invasive tumour. Overall, adverse events and immunogenicity were also comparable between ABP 980 and Herceptin.

The randomized, double-blind, phase III study was started in April 2013 and planned to enrol 827 adult females with histologically confirmed invasive breast cancer. It is being carried out at 99 centres in Belarus, Brazil, Bulgaria, Canada, Chile, Germany, Greece, Hungary, Italy, Mexico, Poland, Romania, Russia, Serbia, South Africa, Spain, Ukraine and the UK and is expected to be completed in February 2017.

Sean Harper, Executive Vice President of Research and Development at Amgen said ‘We believe this study confirms no clinically meaningful differences between ABP 980 and trastuzumab, and we look forward to continued discussions with regulatory authorities’.

Rival biosimilars maker Celltrion received approval for its biosimilar trastuzumab, Herzuma, with the Korean Ministry of Food and Drug Safety (MFDS) in January 2014 [1]. The company also started a phase III trial in the European Economic Area in April 2014 [2].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 26]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-approved-in-Korea
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion starts phase III biosimilar trastuzumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 26]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-starts-phase-III-biosimilar-trastuzumab-trial

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Source: Amgen, ClinicalTrials.gov

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