- At three years, 88.3% of people treated with Kadcyla in the adjuvant HER2-positive early breast cancer setting did not have their breast cancer return compared to 77.0% treated with Herceptin, an 11.3% improvement
- People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease
- Data from the phase III KATHERINE study will be submitted to health authorities globally, including the US Food and Drug Administration and European Medicines Agency
- Results are being presented at the 2018 San Antonio Breast Cancer Symposium, featured in the press programme and simultaneously published in the New England Journal of Medicine on Wednesday, 5 December 2018
Roche today announced that the phase III KATHERINE study met its primary endpoint, showing Kadcyla (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.0001) 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% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an 11.3% 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.[1,2,3]
“The KATHERINE results demonstrate a significant reduction in the risk of recurrence of HER2-positive early breast cancer in people with residual disease after neoadjuvant therapy, and we look forward to submitting these data to health authorities as soon as possible,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure with every advance in reducing disease recurrence.”
The goal in treating eBC is to provide people with the best chance for a cure, which may involve treatment before and after surgery as part of a comprehensive treatment approach.[4;5] 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 tumours and helping to improve surgical outcomes.[5;7;8] Adjuvant treatment is given after surgery and is aimed at eliminating any remaining cancer cells in the body to help reduce the risk of the cancer returning.
These results are being presented in an oral session today at the 2018 San Antonio Breast Cancer Symposium (SABCS) at 11.00 am CST (abstract GS1-10) and featured in the official SABCS press programme at 07.15 am CST. These results will simultaneously be published in the New England Journal of Medicine.
About the KATHERINE study
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 invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy. The primary endpoint of the study is iDFS, which, in this study is defined as the time from randomisation free from invasive breast cancer recurrence or death from any cause. Secondary endpoints include disease-free survival and overall survival.
Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues.[2;3] It combines two anti-cancer properties joined together by a stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1. Kadcyla is the only ADC approved as a single agent in 104 countries including the US and EU for the treatment of people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane chemotherapy, separately or in combination. Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.
About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients. Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.