Another positive result for Genentech

Two Phase III trials of Genentech's 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 (HER2) positive breast cancer.

'The data from these very important Phase III trials suggest for the first time that a therapy that targets women whose tumours have a specific genetic mutation has the potential to reduce the recurrence of disease in early-stage breast cancer patients,' said Dr Susan Desmond-Hellmann, Genentech's president of product development. 'While further follow-up is necessary, the results of this joint interim analysis suggest that adjuvant therapy with Herceptin plus chemotherapy for women with early-stage HER2-positive breast cancer may increase the chance of long-term survival.

'We would also like to thank the women who participated in this study for their tremendous courage in making these results possible. 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,' continued Dr. Hellmann.

Based on the positive results from four recent Phase III trial analyses in the past five weeks, three of which occurred earlier than anticipated, Genentech will continue to evaluate its short- and long-term product demand and to assess its manufacturing plans and capacity to meet expected demand. The company expects to provide further information on manufacturing at the time of Q2 earnings results.