Amgen and Allergan present Phase 3 data of their trastuzumab biosimilar at the ESMO 2017

September 11, 2017 10:51 AM


Amgen and Allergan plc. announced data from a Phase 3 study evaluating the efficacy and safety of ABP 980, a Herceptin (trastuzumab) biosimilar, compared with the originator product in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer.

Results from the neoadjuvant efficacy phase of the study, including pathologic complete response assessed both by local investigators and also by independent pathology review, were presented during a poster discussion at the European Society for Medical Oncology (ESMO) 2017 Congress. Efficacy, safety and immunogenicity data support ABP 980 as a trastuzumab biosimilar and add to the totality of evidence currently under review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

“Biosimilars have the potential to provide more patients access to high-quality therapies with proven safety and efficacy profiles,” said Serafin Morales, M.D., medical oncologist, University Hospital Arnau de Vilanova, Lleida, Spain. “The results presented add to the data package demonstrating similarity between ABP 980 and trastuzumab.”

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 prespecified equivalence margins were +/-13 percent for RD and 0.759 to 1.318 for RR. According to local review, 48 percent and 40.5 percent of patients in the ABP 980 arm and trastuzumab arm, respectively, achieved pathologic complete response. RD and RR of pathologic complete response were 7.3 percent (90 percent CI: 1.2, 13.4) and 1.19 (90 percent CI: 1.033, 1.366) respectively. Based on central independent review, which was conducted as part of a sensitivity analysis, 47.8 percent and 41.8 percent in the ABP 980 arm and trastuzumab arm, respectively, achieved pathologic complete response. RD and RR of pathologic complete response respectively were 5.8 percent (90 percent CI: -0.5, 12.0) and 1.14 (90 percent CI: 0.993, 1.312).

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

“At the heart of Amgen’s commitment to biosimilars is our mission to serve patients. We are leveraging our more than 35 years of biotechnology experience and using the same personnel, services and manufacturing expertise from the company’s innovative business to produce high-quality, reliably supplied biosimilars for some of the most complex diseases,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The results presented reinforce the potential of ABP 980 for breast cancer patients, and we look forward to continued discussions with regulatory authorities.”

“Allergan is proud to be collaborating with Amgen on the development of several oncology biosimilars that require significant expertise, infrastructure and investment to ensure safe therapies for patients,” said David Nicholson, Ph.D., chief research and development officer, Allergan. “We are excited about the progress of ABP 980 and are committed to its development in hopes of providing patients with an effective alternative option.”

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 has been approved by the FDA and European authorities.

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