Genentech reports encouraging results from Phase III breast cancer trial

Mon. June 01, 2009; Posted: 01:12 PM

Jun 01, 2009 (Datamonitor via COMTEX) -- DNA | Quote | Chart | News | PowerRating -- Genentech, a biotechnology company, has reported results of a Phase III study that showed Avastin plus commonly used chemotherapies, including capecitabine and anthracycline-based therapies, increased the time women receiving first-line therapy for advanced HER2-negative breast cancer lived without the disease worsening, compared to the chemotherapies alone. The safety profile of Avastin was consistent with previous experience, and no new safety signals for Avastin were observed in the study.

The Phase III study (Ribbon 1) comprised two independently powered study groups. Group one evaluated capecitabine plus Avastin versus capecitabine plus placebo. Group two evaluated a taxane or anthracycline-based chemotherapy plus Avastin versus the chemotherapy plus placebo. The taxanes in the study were protein-bound paclitaxel or docetaxel. The anthracycline-based chemotherapies were doxorubicin- or epirubicin-based regimens.

According to Genentech, patients receiving Avastin plus capecitabine (group one) had a 45% improvement in the time they lived without their disease worsening or death compared to those who received the chemotherapy alone (hazard ratio=0.69; p=0.0002, 31% risk reduction).

Patients receiving Avastin plus taxane or anthracycline-based chemotherapies (group two) had a 55% improvement in the time they lived without their disease worsening or death compared to those who received chemotherapy alone (hazard ratio=0.64; p<0.0001, 36% risk reduction), the company said.

Hal Barron, chief medical officer of Genentech, said: "Avastin has been studied as a first-line treatment in more than 2,600 women with advanced breast cancer in three Phase III trials, and we have confidence in its ability to help delay breast cancer progression. We plan to submit data from the Ribbon 1 and Avado studies to the FDA in the second half of 2009."

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