The Swiss pharmaceutical company Roche and Roche Group member Genentech have announced that addition of bevacizumab (Avastin) to chemotherapy improved progression-free survival (PFS) over chemotherapy alone in the phase III OCEANS ovarian cancer study, meeting the study’s primary endpoint.
Bevacizumab, a humanized monoclonal antibody, is thought to work by blocking vascular endothelial growth factor (VEGF), a protein released by both normal cells and cancer cells that promotes angiogenesis. VEGF overexpression has been found to mediate important developments in ovarian cancer tumorigenesis and proliferation.
OCEANS, a 484-patient, multicenter, randomized, double-blind placebo-controlled trial, assessed chemotherapy with carboplatin plus gemcitabine (Gemzar) in conjunction with bevacizumab at 15 mg/kg every 3 weeks (or placebo) and followed by continued use of bevacizumab alone (or placebo) in patients with platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer.
The study showed that women who received the combination of bevacizumab and chemotherapy, followed by the continued use of bevacizumab alone, had a longer PFS than women who received just chemotherapy. Full data are to be presented at an upcoming medical meeting.
The OCEANS trial results build on findings from two previous phase III studies in newly diagnosed ovarian cancer, GOG 0218 and ICON7. Both of these studies showed that front-line bevacizumab in combination with standard chemotherapy (carboplatin and paclitaxel), followed by continued use of bevacizumab alone, significantly increased PFS compared with chemotherapy alone. Based on the results from GOG 0218 and ICON7, Roche has submitted a European Union marketing authorization application for use of bevacizumab in the front-line setting of ovarian cancer management, and the company expects a decision from the Committee for Medicinal Products for Human Use (CHMP) later in 2011. Genentech plans to submit applications to the US Food and Drug Administration this year for the use of bevacizumab in ovarian cancer.
No new safety findings were observed in the OCEANS study, and adverse events were consistent with those seen in previous pivotal trials of bevacizumab, according to a news release from Roche announcing the trial results. “We are very pleased with the results of the OCEANS study, as women with ovarian cancer need new treatment options,” said Hal Barron, MD, chief medical officer and head of Global Product Development for Roche. “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.”