Genentech's Avastin, chemotherapy Phase III combination study data on ovarian cancer presented at ASCO

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from OCEANS, a Phase III study evaluating Avastin^® (bevacizumab) in combination with chemotherapy (gemcitabine and carboplatin) followed by the continued use of Avastin alone in women with previously treated (recurrent) platinum-sensitive ovarian cancer. Women who received Avastin experienced a 52 percent reduction in the risk of their disease progressing.

These results were featured in a press briefing today at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO). Full results will be presented in the ASCO Gynecologic Cancer session by Dr. Carol Aghajanian, the OCEANS principal investigator and chief, Gynecologic Medical Oncology Service, Memorial Sloan-Kettering Cancer Center, New York (Abstract LBA5007, June 4, 4:15pm CDT).

"Women with recurrent ovarian cancer need new treatment options, and it is therefore an important advance to halve the risk of disease progression in this incurable cancer," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "These data add to the growing body of evidence supporting Avastin's potential role in this disease, which includes two previously presented Phase III clinical trials in women with newly diagnosed ovarian cancer."

In OCEANS, women with recurrent, platinum-sensitive ovarian cancer, who received Avastin in combination with chemotherapy followed by continued use of Avastin alone until disease progression, experienced the following results:

• A median progression-free survival (PFS; the time without disease progressing) of 12.4 months compared to 8.4 months in women who received chemotherapy alone;
• Tumor shrinkage (overall response rate) in 79 percent of women receiving the Avastin-based regimen compared to 57 percent of women who received chemotherapy alone.

Select adverse events (Grade 3-5) that occurred more often in the Avastin arm compared to the chemotherapy alone arm were hypertension (high blood pressure; 17 percent vs. <1 percent), proteinuria (an excess of protein in the urine; 9 percent vs. 1 percent) and bleeding that does not occur in the central nervous system (6 percent vs. 1 percent). Notably, there were no gastrointestinal perforations (a hole in the stomach or intestine) seen during the safety reporting period of this study.