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Positive phase III results for Amgen’s trastuzumab biosimilar Posted 15/09/2017

Biotech giant Amgen and partner Allergan announced on 9 September 2017 positive data from a phase III study of their trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab).

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

The randomized, double-blind, phase III study evaluated the efficacy and safety of ABP 980 in combination with paclitaxel compared to the originator biological, Roche’s Herceptin (trastuzumab), in female patients with HER2-positive (HER2+), breast cancer. The trial was started in April 2013 and planned to enrol 827 adult females with HER2+ breast cancer. It was 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.

The co-primary endpoints of the study were risk difference (RD) and risk ratio (RR) of pathologic complete response in breast tissue and axillary lymph nodes, and the pre-specified equivalence margins were +/-13% for RD and 0.759 to 1.318 for RR. According to local review, 48.0% and 40.5% of patients in the ABP 980 arm and Herceptin arm, respectively, achieved pathologic complete response. RD and RR of pathologic complete response were 7.3% (90% CI: 1.2, 13.4) and 1.19 (90% CI: 1.033, 1.366) respectively. Based on central independent review, which was conducted as part of a sensitivity analysis, 47.8% and 41.8% in the ABP 980 arm and Herceptin arm, respectively, achieved pathologic complete response. RD and RR of pathologic complete response respectively were 5.8% (90% CI: -0.5, 12.0) and 1.14 (90% CI: 0.993, 1.312).

Frequency, type and severity of adverse events were also similar between ABP 980 and Herceptin. No new safety signals compared to the known safety profile of Herceptin were detected.

The results of the study were presented at the European Society for Medical Oncology (ESMO) 2017 Congress, which was held on 8−12 September 2017 in Madrid, Spain.

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one of which, adalimumab, has been approved by the US Food and Drug Administration [Amjevita (adalimumab-atto)] [1] and by the European Medicines Agency (Amgevita/Solymbic) [2].

Among the drugs that Amgen is developing for biosimilars are cancer treatments Avastin (bevacizumab) and Erbitux (cetuximab) from Roche and Eli Lilly and arthritis and Crohn’s disease treatment Remicade (infliximab) from J & J/Merck.

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Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Amgen, ClinicalTrials.gov

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