Roche announced that a second large, phase-III, international study showed that the combination of Avastin (bevacizumab) and chemotherapy followed by the continued use of Avastin alone, increased the time women with previously untreated ovarian cancer lived without the disease worsening (progression-free survival or PFS, the primary endpoint), compared to chemotherapy alone. Adverse events were consistent with those observed in pivotal trials of Avastin. Data from the study, known as ICON7, will be submitted for presentation at an upcoming medical meeting.
“With few advances in ovarian cancer and a need to improve outcomes for women with this disease, it is encouraging that a second phase-III study showed that Avastin in combination with chemotherapy followed by the continued use of Avastin alone helped women live longer without their disease getting worse,” said Hal Barron, executive vice-president Global Development and chief medical officer for Roche. “ICON7 is part of our continued commitment to understand the full potential of Avastin in ovarian cancer which includes several phase-III studies in combination with other agents and in various stages of the disease.”
The ICON7 study is sponsored by the Medical Research Council (MRC) in the United Kingdom, led by the MRC Clinical Trials Unit and conducted through an international network of researchers in the Gynaecologic Cancer InterGroup (GCIG). In the study, 1,528 women with newly diagnosed ovarian cancer who had already had surgery were randomised to receive one of the following:
ICON7 is an international, multicenter, randomised, open-label, phase-III study in 1,528 women with previously untreated epithelial ovarian, primary peritoneal or fallopian tube carcinoma.
Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor).
The Gynaecologic Cancer InterGroup (GCIG) is an organisation of representatives from international and national research groups performing clinical trials in gynaecological cancer. It aims to promote international collaboration on clinical research by performing high quality clinical trials.