Adding farletuzumab to carboplatin and a taxane failed to improve progression-free survival in patients with platinum-sensitive ovarian cancer, a study published in the Journal of Clinical Oncology has shown.1
Farletuzumab is a humanized monoclonal antibody that binds to folate receptor-α, which is highly expressed in ovarian carcinoma but largely absent from normal tissue.
For the double-blind, phase 3 trial, researchers enrolled 1100 women with ovarian cancer who had their first recurrence 6 to 24 months following completion of platinum-taxane chemotherapy.
All patients received carboplatin plus paclitaxel or docetaxel for 6 cycles. Patients were also randomly assigned 1:1:1 to also receive farletuzumab 1.25 mg/kg, farletuzumab 2.5 mg/kg, or placebo, which was continued weekly as a single-agent until disease progression.
Results showed that progression-free survival was 9.0 months with farletuzumab 1.25 mg/kg, 9.5 months with farletuzumab 2.5 mg/kg, and 9.7 months with placebo. Researchers found that there was no statistically significant difference between the farletuzumab 1.25 mg/kg group and placebo (HR, 0.99; 95% CI: 0.81-1.21) or the 2.5 mg/kg group and placebo (HR, 0.86; 95% CI: 0.70-1.06).
The study also demonstrated that in a prespecified subgroup, baseline levels of CA-125, a biomarker for ovarian cancer, not more than 3 times the upper limit of normal were associated with longer progression-free survival (HR, 0.49; P = .0028) and overall survival (HR, 0.44; P = .0108) for farletuzumab 2.5 mg/kg compared with placebo.
In terms of safety, the most frequently reported adverse events were those associated with chemotherapy.
1. Vergote I, Armstrong D, Scambia G, et al. A randomized, double-blind, placebo-controlled, phase III study to assess efficacy and safety of weekly farletuzumab in combination with carboplatin and taxane in patients with ovarian cancer in first platinum-sensitive relapse [published online ahead of print March 21, 2016]. J Clin Oncol. doi:10.1200/JCO.2015.63.2596.