publication date: Aug. 4, 2016

Breast Cancer Phase III Trial Rules Out Inferiority of Trastuzumab Biosimilar ABP 980


Amgen and Allergan plc announced results from a phase III study evaluating efficacy and safety of biosimilar ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive early breast cancer.

ABP 980 is being developed as a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody which targets HER2. The active ingredient of ABP 980 is a humanized monoclonal antibody that has the same amino acid sequence as trastuzumab. ABP 980 has the same pharmaceutical dosage form and strength as trastuzumab in the U.S. and the European Union.

The results ruled out inferiority compared to trastuzumab, but could not rule out superiority based on its primary efficacy endpoint—the difference of the percentage of patients with a pathologic complete response: the primary endpoint had a prespecified equivalence margin of +/- 13 percent, and the observed upper end of the confidence interval was 13.4 percent.

Adverse events were comparable between ABP 980 and trastuzumab overall. In the neoadjuvant phase of the study, which included chemotherapy, there were more serious adverse events reported in the ABP 980 group, the majority of which were reported by the investigators as unlikely related to investigational product. In the adjuvant phase of the study, which did not include chemotherapy, … Continue reading CCL July – Phase III Trial Rules Out Inferiority of Trastuzumab Biosimilar ABP 980

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