ROCHE FILES IN EUROPE FOR HERCEPTIN IN ADVANCED BREAST CANCER

Roche has submitted a marketing authorization application to the European Medicines Agency (EMEA) for Herceptin (trastuzumab) as treatment for advanced HER2-positive and hormone-receptor-positive breast cancer. The application is based on data from the international TAnDEM study, which showed that the addition of Herceptin to hormonal therapy doubles the median progression-free survival, from 2. 4 months to 4.8 months.

HER2-positive breast cancer is an aggressive form of the disease that requires special and immediate attention because the tumors are fast-growing and there is a higher likelihood of relapse. Up to a half of HER2-positive breast cancers are also hormone-receptor-positive, a form of the disease that has typically been considered lower risk, due to successful treatment with hormonal therapies. However, TAnDEM is the first randomized study to show that this specific subset of co-positive patients (both HER2- and hormone receptor positive) is actually higher-risk, making the positive results with Herceptin even more meaningful.

TAnDEM is Phase III trial that evaluated Herceptin in combination with the hormonal therapy anastrozole versus anastrozole alone as first-line therapy (or second-line hormonal therapy) in postmenopausal women with advanced (metastatic), HER2-positive and hormone-receptor-positive breast cancer. Enrolment to the trial began in 2001, and 208 HER2 and hormone-receptor co-positive patients were randomized at 77 centers in 22 countries.

Median progression-free survival, the primary endpoint of the trial, was 4.8 months for patients who received the combination compared with 2.4 months for patients who received hormonal therapy alone. Patients in the combination arm also responded significantly better to treatment (overall response rate was 20.3 percent versus 6.8 percent. There was also a positive trend in median overall survival (28.5 months versus 23.9 months), despite the fact that in the hormonal therapy alone arm, more than half of patients crossed over to receive Herceptin during the trial when their disease had progressed, and an additional 15 patients received Herceptin at a later time point.