Dr. Kolberg Discusses the LILAC Study of ABP 980

Hans-Christian Kolberg, MD, head, Department of Obstetrics and Gynecology, Breast Cancer Center, and Gynecologic Cancer Center at Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe, Bottrop, Germany, discusses the LILAC study (NCT01901146) of the biosimilar ABP 980.

Findings presented at the 2018 ASCO Annual Meeting showed that the pathologic complete response (pCR) rate associated with the trastuzumab (Herceptin) biosimilar ABP 980 was equivalent to that of reference trastuzumab in patients with HER2-positive early breast cancer, based on central laboratory evaluation. Of the 338 patients on the LILAC study, the 162 (47.8%) randomized to ABP 980 achieved a pCR compared with the 138 (41.8%) who were randomized to reference trastuzumab.

This trial was conducted at 97 centers in 20 countries in Europe and other regions. The coprimary endpoints were risk difference and risk ratio of pCR in breast tissue and axillary lymph nodes of tumor samples based on local laboratory evaluation. The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for ABP 980 as a treatment for patients with HER2-positive metastatic breast cancer, HER2-positive early breast cancer, and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.