Roche’s international study confirms positive results of Herceptin

The successful results of a North American study, presented earlier this week, have now been replicated in a large-scale study involving 39 different countries. Interim analysis of phase III study data based on almost 5,100 patients, confirmed Herceptin’s potential to reduce the risk of cancer returning.

The studies provide consistent evidence that Herceptin can reduce the risk of cancer re-occurring in women with early-stage HER2-positive breast cancer. Shares in both Roche and Genentech have already risen as a result of recent findings.

HER2-positive breast cancer affects approximately 20-30% of women with breast cancer and is a particularly aggressive form of the disease which has a poor prognosis.

“The combined data from over 8,000 patients analyzed so far make a compelling case for Herceptin as an optimal treatment in HER2-positive early breast cancer and has potential to change the way breast cancer is managed,” said William Burns, CEO of Roche’s Pharmaceuticals Division.

The study conducted by Roche and Breast International Group (BIG), evaluated the use of Herceptin versus observation following a wide range of primary chemotherapy (chemotherapy given before or after surgery) and radiotherapy (if applicable). An interim analysis met its primary efficacy endpoint by showing that patients who received Herceptin had statistically significant improvement in disease-free survival (the length of time after treatment during which no disease is found).

The secondary endpoint of overall survival has not yet been reached, possibly due to short follow up. Patients in the study will continue to be monitored, and an improvement in overall survival is possible to be achieved as the data mature.