Genentech says Phase III KATHERINE study met primary endpoint
Genentech, a member of the Roche Group, announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla as a single agent significantly reduced the risk of disease recurrence or death compared to Herceptin as an adjuvant treatment in people with HER2-positive early breast cancer, or EBC, who have residual disease present following neoadjuvant treatment. The safety profile of Kadcyla in the KATHERINE study was consistent with previous clinical trials and no new safety signals were identified. The KATHERINE trial investigated a population of people with HER2-positive EBC who did not achieve a pathological complete response to neoadjuvant treatment. This state of residual disease is associated with a worse prognosis. The goal in treating early breast cancer is to provide people with the best chance for a cure. While we come closer to this goal with each advance, many people still have a disease recurrence in the long-term. Neoadjuvant treatment is given before surgery with the goal of shrinking tumors and helping to improve surgical outcomes. Adjuvant treatment is given after surgery as part of a complete EBC treatment regimen and is aimed at eliminating any remaining cancer cells in the body to help reduce the risk of the cancer returning.