Investigators Chart ABP 980 Biosimilar Uptake in European Clinics

January 4, 2021
Tony Hagen

Tony Hagen is senior managing editor for The Center for Biosimilars®.

Among patients treated for metastatic breast cancer, 40% switched to ABP 980.

A study of the trastuzumab biosimilar ABP 980 (Kanjinti) in Europe found strong uptake patterns, according to an abstract presentation at the 2020 San Antonio Breast Cancer Symposium.

ABP 980 is approved in Europe and the United States for the treatment of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer and metastatic gastric cancer. Investigators sought to understand the real-world application of this product in clinical treatment of patients with breast cancer.

They enrolled patients 18 years or older with a history of breast cancer of any disease or treatment phase, seeking primarily to understand patient demographics and disease characteristics. Exploratory end points included cardiac dysfunction, infusion-related problems, other adverse events, and other safety issues. Efficacy was a secondary end point.

Enrollment included 135 women from Poland, Italy, the Netherlands, France, and Spain, mostly from hospital sites, both academic and public or private. The mean patient age was 58.3 years.

The investigators said 28% of sites had policies on biosimilar use and that 36% of patients were informed they were being started on a biosimilar, with 34% being notified what brand of biosimilar would be used. Twenty-two percent, 27%, 13%, and 28% of patients had stage I, II, III, or IV disease, respectively, at the time ABP 980 was initiated. They also said 68% of patients had estrogen/progesterone receptor–positive tumors. All patients (n = 73) who had been evaluated for Eastern Cooperative Oncology Group performance had a score of 0 or 1.

There was roughly equal use of ABP 980 across treatment settings: neoadjuvant, 39%; adjuvant 30%; and metastatic, 30%.

Among patients who received treatment for metastatic breast cancer (n = 41), 56% and 20% received it for frontline and second-line treatment, respectively. The investigators said that 40% (n = 54) of patients switched to ABP 980 from another trastuzumab product. Of those, 44% switched from the intravenous form of the originator biologic and 15% switched from the subcutaneous form. Most who switched to the subcutaneous form were receiving treatment for metastatic disease.

The investigators concluded there was ABP 980 “uptake across a mixture of institution types and breast cancer treatment settings, including those with curative potential.” The study is ongoing.

Reference

Kufel-Grabowska J, San T, Bernardo A, et al. Patterns of use of a trastuzumab biosimilar (ABP 980) in patients with HER2+ breast cancer treated in clinical practice in Europe: An interim analysis from an observational chart review study (GARDENIA). Poster presented at: San Antonio Breast Cancer Symposium; December 8-11, 2020. PS10-50.


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