Genentech reports positive results from Phase III breast cancer study

In this Roche-sponsored, placebo-controlled Phase III trial (Avado), two dose levels of Avastin in combination with docetaxel chemotherapy showed a statistically significant improvement in progression-free survival (PFS) compared to docetaxel chemotherapy alone, according to an investigator-assessed analysis. No new safety signals for Avastin were observed in the study.

The pre-specified analysis of Avado for US regulatory purposes showed that Avastin combined with chemotherapy improved PFS by up to 64% (hazard ratio of 0.61; p<0.0001) in the 15mg/kg treatment arm and by up to 45% (hazard ratio of 0.69; p=0.0035) in the 7.5mg/kg treatment arm, compared to chemotherapy alone. Overall response rate, a secondary endpoint, was also positive and supported the PFS benefit observed in this study. After one year, 83% and 78% of patients were alive in the 15mg/kg and 7.5mg/kg Avastin treatment arms, compared to 73% of patients receiving chemotherapy alone. Genentech is required to submit to the FDA by mid-2009 the results of Avado and Ribbon I, a third Phase III study in first-line metastatic breast cancer. Results for the Ribbon I study are expected later in 2008. Susan Desmond-Hellmann, president of product development, said: "The totality of the Avado results, including positive primary and secondary endpoints and reassurances of safety, support the benefit of Avastin in extending the time women lived without their disease progressing when combined with chemotherapy as a first-line treatment."