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news.Amgen and Allergan have said that a late-stage trial of their treatment being developed as a biosimilar to Roche’s breast cancer drug trastuzumab (Herceptin) met its primary endpoint.
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The phase 3 study evaluated the effectiveness and safety of ABP 980 compared with trastuzumab in adult female patients with HER2-positive early breast cancer.
There were 725 patients randomized, with 364 subjects in the ABP 980 group and 361 in the trastuzumab group.
Results demonstrated that ABP 980 was not inferior to trastuzumab. However, researchers could not make an assessment of superiority depending on pathologic complete response, the study’s primary efficacy endpoint.
The prespecified equivalence margin was plus/minus 13% and the observed upper end of the confidence interval was slightly higher at 13.4%. Adverse events were comparable.
In the neoadjuvant phase, more patients treated with ABP 980 experienced adverse events. Most likely were unrelated to ABP 980, according to investigators.
Serious adverse events were comparable between treatment groups in the study’s adjuvant phase, which did not include chemotherapy.
The companies noted that the overall results also demonstrated comparable immunogenicity.
Amgen executive vice president of research and development Sean Harper 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.
"Biosimilars are approved based on the analytical, nonclinical and clinical data, and we believe that the totality of the evidence we've generated supports ABP 980 as highly similar to the reference product."