Phase III success for Roche breast cancer drug

Roche said the phase III study KATHERINE met its primary endpoint, showing Kadcyla (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death compared to Herceptin (trastuzumab) as an adjuvant treatment in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment.

“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,” said Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to discussions with regulatory authorities with the goal of bringing this new treatment option to patients as soon as possible.”

Full results will be submitted to health authorities around the world, and will be presented at the 2018 San Antonio Breast Cancer Symposium in December. 

Kadcyla is an antibody-drug conjugate consisting of the monoclonal antibody trastuzumab targeting HER2 linked to the cytotoxic agent emtansine. KATHERINE is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive eBC who have pathological residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy.