Dr. Kolberg on the LILAC Study of ABP 980 in Breast Cancer

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 phase III LILAC study, which examined ABP 980 (Kanjinti; trastuzumab-anns), a trastuzumab (Herceptin) biosimilar, in early-stage HER2-positive breast cancer.

The LILAC study evaluated ABP-908 in the neoadjuvant setting. The primary endpoint of the study was pathologic complete response (pCR), which is more easily evaluated than endpoints in the metastatic setting such as response rate, says Kolberg. Many biosimilars are tested in the neoadjuvant setting and use pCR as the primary endpoint. Though, they can be tested in any setting.

In the LILAC study, patients received run-in anthracycline-based chemotherapy. After 4 cycles of chemotherapy, patients were given paclitaxel and randomized to trastuzumab or ABP 980. Patients underwent surgery within 3 to 7 weeks after their last dose of neoadjuvant therapy. The LILAC study is the first and only multicenter study to do a pCR central review, says Kolberg. The pCR central review was difficult to do in the multicenter study because patient specimens were gathered from all over the world; however, this was the only way to show similarity between trastuzumab and ABP 980.