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ESMO 2017: Comparison of Biosimilar ABP 980 and Trastuzumab in HER2-Positive Breast Cancer

By: Susan Reckling
Posted: Thursday, September 21, 2017

A biosimilar candidate to trastuzumab, ABP 980, and trastuzumab are clinically equivalent in the neoadjuvant setting for HER2-positive early breast tumors, according to the findings of a randomized multicenter study. Gunter von Minckwitz, MD, PhD, of the German Breast Group, Neu-Isenburg, Germany, and colleagues reported the results of this double-blind trial in a poster presentation at the 2017 European Society for Medical Oncology (ESMO) Congress (Abstract 151PD).

A total of 827 women with HER2-positive early breast cancer were enrolled in the study, with 725 randomized for treatment: 364 were given ABP 980, and 361 were given trastuzumab. Included in the pathologic complete response evaluable population were 696 patients (358 in the biosimilar group and 338 in the trastuzumab group).

Based on a central independent review, the pathologic complete response rate was 47.8% in the ABP 980 arm and 41.8% in the trastuzumab arm. At least one adverse event was reported in about 80% of both groups, with approximately 14% of both groups experiencing a grade ≥ 3 adverse event. The most common side effects in both groups was arthralgia, asthenia, neutropenia, peripheral neuropathy, and anemia.



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