Roche (Basel, Switzerland) has submitted a Marketing Authorisation application to the European Medicines Agency (EMEA) for Herceptin (trastuzumab) as an adjuvant treatment for early-stage HER2-positive breast cancer.
The application is based on data from the international HERA (HERceptin Adjuvant) study, which showed use of the drug after standard chemotherapy to reduce the risk of cancer resurgence by 46%.
Conducted by Roche and the Breast International Group (BIG), HERA was one of the largest adjuvant studies ever carried out among breast cancer patients, enrolling 5,100 HER2-positive patients at 480 sites in 39 countries across the world.
A randomised trial, it evaluated Herceptin against observation every three-weeks for 12 or 24 months in women with early-stage HER2-positive breast cancer, allowing for the use of a wide range of chemotherapy regimens. Both lymph node-positive and lymph node-negative patients were eligible for entry into the trial, which, according to the interim analysis, met its primary efficacy endpoint, showing 'significant improvement in disease-free survival' in the 12-month arm.
At a median follow-up of one year, the secondary endpoint of overall survival had not reached statistical significance, 'but showed a clear trend towards an improvement in overall survival, which is to be confirmed as the data mature'.
The interim analysis did not include a comparison of 12 versus 24 months of treatment, but data will be made available as the study matures.
No safety concerns were raised by the Independent Data Monitoring Committee (IDMC), with the incidence of congestive heart failure standing at 0.5% in the Herceptin arms versus 0% in the observation arm. Patients will continue to be followed for any side effects.
Genentech has also filed a supplemental Biologic License Application (sBLA) for the use of Herceptin in early-stage HER2-positive breast cancer with the US Food and Drug Administration (FDA). The application is based on data from a combined interim analysis of two large US trials, and Genentech has requested a priority review designation.
HER2-positive breast cancer is caused by increased quantities of the HER2 protein on the surface of tumour cells. It affects approximately 20-30% of women with breast cancer.
Herceptin is a humanised antibody designed to target and block the function of HER2. It is approved for use in patients with advanced metastatic breast cancer whose tumours over-express the HER2 protein and is indicated for use as a first-line therapy in combination with docetaxel in HER2-positive patients who have not received chemotherapy and in combination with paclitaxel where anthracyclines are unsuitable. It is also indicated as a single agent in third-line therapy.