Genentech's OCEANS Phase III study of Avastin in platinum-sensitive ovarian cancer meets primary endpoint

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that OCEANS, a Phase III study evaluating Avastin^® (bevacizumab) in combination with chemotherapy (carboplatin and gemcitabine) followed by continued use of Avastin alone until disease progression in women with previously treated (recurrent), platinum-sensitive ovarian cancer, met its primary endpoint.

“We are very pleased with the results of the OCEANS study, as women with ovarian cancer need new treatment options”

The study showed that women who received a combination of Avastin and chemotherapy, followed by the continued use of Avastin alone, lived longer without their disease worsening (progression-free survival or PFS), compared to women who received chemotherapy alone. No new safety findings were observed and adverse events were consistent with those seen in previous pivotal trials of Avastin. Full data from the OCEANS study will be submitted for presentation at an upcoming medical meeting.

"We are very pleased with the results of the OCEANS study, as women with ovarian cancer need new treatment options," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Avastin has now demonstrated a significant improvement in PFS in ovarian cancer in three large Phase III studies, and we look forward to sharing the data at an upcoming medical meeting."

The results from this trial build on findings from two previous Phase III studies (GOG 0218 and ICON7) in women with newly diagnosed ovarian cancer. Both of these studies demonstrated that front-line Avastin in combination with standard chemotherapy (carboplatin and paclitaxel), followed by the continued use of Avastin alone, significantly increased the time women with ovarian cancer lived without their disease getting worse, compared to those treated with chemotherapy alone. Roche has submitted a European Union marketing authorization application for the use of Avastin in the front-line setting based on the results from GOG 0218 and ICON7 and expects a decision from the Committee for Medicinal Products for Human Use (CHMP) later this year. Genentech plans to submit applications in the United States for the use of Avastin in ovarian cancer in 2011.