Date: 2011-02-08
Type of information:
phase: 3
Announcement: results
Company: Roche (Switzerland)
Product: Avastin® (bevacizumab)
Action mechanism: antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor)
Disease: reduction of cancer pain
Therapeutic area: Cancer - Oncology - CNS diseases
Country:
Trial details:
Latest
news: 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.
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.
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 (EU) 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 US for the use of Avastin® in ovarian cancer in 2011.
