Positive Preliminary Results Prompt Genentech to Stop Herceptin Trials Early

Based on promising results of two Phase III clinical studies, Genentech plans to seek approval from the FDA for the use of Herceptin as an adjuvant therapy in patients with early stages of breast cancer, the company announced.

The two studies, sponsored by the National Cancer Institute, compared Herceptin (trastuzumab) 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 (HER2) positive breast cancer. In both trials, Herceptin demonstrated an improvement in the primary endpoint of disease-free survival and in the secondary endpoint of overall survival.

"The data from these very important Phase III trials suggest for the first time that a therapy that targets women whose tumors have a specific genetic mutation has the potential to reduce the recurrence of disease in early-stage breast cancer patients," said Susan Desmond-Hellmann, Genentech's president of product development. "Based on the strength of the results, we will work with the cooperative groups to prepare these data for discussion with the FDA about a filing for Herceptin in the adjuvant setting based on this interim analysis."