Interim Analysis Shows Positive Results for Herceptin Plus Chemotherapy

Genentech has announced that two Phase III trials of Herceptin were stopped early after a preliminary joint interim analysis demonstrated an improvement in the primary endpoint of disease-free survival and in the secondary endpoint of overall survival.

The trials compared Herceptin plus chemotherapy to chemotherapy alone as adjuvant therapy following initial treatment with surgery for women with early stage (or cancer that has not spread beyond the breast and associated lymph nodes) human epidermal growth factor receptor 2 positive breast cancer.

The two studies were sponsored by the NIH's National Cancer Institute and conducted by a network of researchers led by the National Surgical Adjuvant Breast and Bowel Project and the North Central Cancer Treatment Group, which conducted this prospectively designed joint interim analysis following consultation with the FDA.