The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
“The majority of women with ovarian cancer will become resistant to platinum therapy, and a quarter of women will have platinum-resistant disease at the time of a first recurrence. New treatment options are needed,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development.
The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” The supplemental Biologics License Application for bevacizumab plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from the phase III AURELIA trial.
AURELIA is a company-sponsored, multicenter, randomized, open-label, phase III study in 361 women with platinum-resistant recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer who had received no more than two anticancer regimens prior to enrollment in the trial. Participants were randomly assigned to one of six treatment arms (paclitaxel, topotecan, or liposomal doxorubicin with or without bevacizumab).
The study met its primary endpoint and showed that bevacizumab plus chemotherapy reduced the risk of disease progression by 52% compared to chemotherapy alone; the median progression-free survival was 6.7 months for bevacizumab plus chemotherapy vs 3.4 months for chemotherapy alone (hazard ratio [HR] = 0.48, P < .001). No statistically significant difference was seen in the secondary endpoint of overall survival (P < .174).
Women in the bevacizumab-plus-paclitaxel arm (n = 60) experienced a 54% improvement in progression-free survival (10.4 vs 3.9 months; HR = 0.46, 95% confidence interval [CI] = 0.30–0.71) and a 35% improvement in overall survival (22.4 vs 13.2 months; HR = 0.65, 95% CI = 0.42–1.02).
The study showed women who received bevacizumab plus chemotherapy had a significantly higher objective response rate compared to chemotherapy alone when evaluated by the RECIST criteria (27.3% vs 11.8%, respectively; P = .001).
Grade 3 to 5 adverse events occurring at a higher incidence in women receiving bevacizumab plus chemotherapy compared to women receiving chemotherapy alone were hypertension (7% vs 1%), proteinuria (2% vs 0 %) and gastrointestinal perforations (2% vs 0%). ■