Phase III KATHERINE study of Kadcyla meets primary endpoint in breast cancer and is published in NEJM.- Genentech/Roche.

Genentech/Roche announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla (ado-trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival; iDFS) by 50 percent compared to Herceptin (trastuzumab) as an adjuvant (after surgery) treatment in people with HER2-positive early breast cancer (EBC) who have residual disease (pathological invasive residual disease in the breast and/or axillary nodes) present following neoadjuvant (before surgery) treatment. At three years, 88.3 percent of people treated with Kadcyla did not have their breast cancer return compared to 77.0 percent treated with Herceptin, an 11.3 percent improvement. Kadcyla improved iDFS irrespective of hormone receptor status, lymph node status and prior HER2-targeted treatment regimen received in the neoadjuvant setting.

The safety profile of Kadcyla was consistent with that seen in previous studies, and no unexpected or new safety signals were identified. These results are being presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) and will simultaneously be published in the New England Journal of Medicine.

See: "Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer" Gunter von Minckwitz et al. New England Journal of Medicine, December 5, 2018 DOI: 10.1056/NEJMoa1814017