A phase III double-blind placebo-controlled trial (AVF4095g) in 484 patients showed that the monoclonal antibody improved outcomes in this setting when added to standard platinum-based chemotherapy (carboplatin plus gemcitabine).
Patients who had histologically documented disease recurrence within 6 months of previous platinum-based chemotherapy and had not received carboplatin or gemcitabine in the recurrent setting were included in the study. Those who had received prior therapy with bevacizumab or other VEGF-targeting agents were excluded.
Patients received a standard backbone of carboplatin and gemcitabine plus either placebo or bevacizumab 15mg/kg by intravenous infusion every 3 weeks at the same time as the chemotherapy for 6-10 cycles, then continued as monotherapy until disease progression.
Median progression-free survival based on investigator assessment using modified RECIST criteria (the primary endpoint) was significantly higher in the bevacizumab group than in the placebo group: 12.4 vs 8.4 months (p<0.0001). Similar results were observed when the primary endpoint was independently reviewed.