Date: 2012-06-02
Type of information:
phase: 3
Announcement: results
Company: Roche (Switzerland)
Product: Avastin® (bevacizumab)
Action
mechanism: Avastin® is an antibody that precisely targets and inhibits vascular endothelial growth factor (VEGF)for continuous tumour control. Avastin®’s precise VEGF inhibition allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.
Disease: ovarian cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: AURELIA is a multicentre, randomised, open-label, two-arm phase III study in 361 women with platinum-resistant recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer. Women in AURELIA had received no more than two anticancer regimens prior to enrolment in the trial. The trial was designed to evaluate Avastin® (10mg/kg every two weeks or 15mg/kg every three weeks) in combination with standard chemotherapy (either weekly paclitaxel or topotecan or pegylated liposomal doxorubicin) compared to standard chemotherapy alone. The trial was set up in cooperation with the Group d'Investigateurs Nationaux pour l\'Etude des Cancers Ovariens (GINECO) and was conducted by the international network of the Gynecologic Cancer Intergroup (GCIG) and the pan-European Network of Gynaecological Oncological Trial Groups (ENGOT). The primary endpoint of the study was progression-free survival. The secondary endpoints of the study included overall survival, objective response rate, Quality of Life, safety and tolerability.
AURELIA is the fourth phase III study of Avastin in ovarian cancer (following GOG 0218, ICON7 and OCEANS) to show that adding Avastin to chemotherapy significantly increased the time women with this disease lived without their disease getting worse.
Latest
news: Roche has announced results from AURELIA, a phase III study that evaluated treatment with Avastin® (bevacizumab) in combination with standard chemotherapy (weekly paclitaxel, topotecan or pegylated liposomal doxorubicin) in women with ovarian cancer whose disease had worsened due to resistance to platinum-containing chemotherapy. The risk of progression was reduced by 52 percent in women who received Avastin® plus chemotherapy compared with those who received chemotherapy alone (HR = 0.48, p<0.001). The study met its primary endpoint of a significant improvement in progression free survival (PFS, the time a woman lives without the disease getting worse). Adverse events in AURELIA were consistent with those seen in previous pivotal trials of Avastin across tumour types. These results were featured at the 48th Annual Meeting of the American Society of Clinical Oncology. Full results will be presented in the ASCO Gynaecologic Cancer Oral Abstract session by Professor Eric Pujade-Lauraine, the AURELIA Principal Investigator and Head of the Medical Oncology Dept., Hopitaux Universitaires, Paris Centre, Hôpital Hôtel-Dieu (Abstract LBA5002, Saturday 2 June, 3:30 p.m. CDT). In December 2011 Avastin received European approval for use in the front-line treatment of advanced ovarian cancer, based on the results from GOG 0218 and ICON7. Roche will share the AURELIA data with health authorities and discuss appropriate next steps.
