publication date: Dec. 14, 2018
Kadcyla cut risk of disease recurrence vs. Herceptin in HER2-positive early breast cancer with residual disease after neoadjuvant treatment
Genentech said 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) by 50 percent (HR=0.50, 95% CI 0.39-0.64, p<0.0001) compared to Herceptin (trastuzumab) as an adjuvant treatment in people with HER2-positive early breast cancer who have residual disease (pathological invasive residual disease in the breast and/or axillary nodes) present following neoadjuvant treatment.
Genentech is a member of Roche group.
At three years, 88.3 percent of people treated with Kadcyla did not have their breast cancer return compared to 77 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 were presented in an oral session at the 2018 San Antonio Breast Cancer Symposium and published in the New England Journal of Medicine.
KATHERINE is an international, multi-center, two-arm, randomized, 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 randomization free from invasive breast cancer recurrence or death from any cause. Secondary endpoints … Continue reading Kadcyla cut risk of disease recurrence vs. Herceptin in HER2-positive early breast cancer with residual disease after neoadjuvant treatment
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