A randomized phase 3 trial of trastuzumab emtansine met its primary endpoint of reducing risk for disease recurrence or death compared with trastuzumab among adults with HER2-positive early breast cancer with residual disease following neoadjuvant treatment, according to the manufacturer.
The treatment also appeared safe.
Trastuzumab emtansine (Kadcyla, Roche) is an antibody-drug conjugate engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissue.
The phase 3, open-label, multicenter KATHERINE study assessed trastuzumab emtansine among adults with HER2-positive early breast cancer who had pathological residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included trastuzumab (Herceptin, Genentech) and taxane-based chemotherapy.
Researchers randomly assigned patients to adjuvant trastuzumab emtansine or trastuzumab.
Invasive DFS, defined as time from randomization to invasive breast cancer recurrence or death from any cause, served as the primary endpoint. Secondary endpoints included DFS and OS.
Researchers will present full results at the San Antonio Breast Cancer Symposium in December.
Roche today reported trastuzumab emtansine improved invasive DFS compared with trastuzumab alone.
“We are highly encouraged by these positive results with adjuvant Kadcyla treatment in people with HER2-positive early breast cancer who have residual disease after neoadjuvant therapy,” Sandra Horning, MD, chief medical officer and head of global product development at Roche, said in a company-issued press release. “We look forward to discussions with regulatory authorities with the goal of bringing this new treatment option to patients as soon as possible.”