The Phase III randomized trial of farletuzumab is designed as a three-armed, double-blinded, controlled study.
The study will evaluate farletuzumab at two different dosages in combination with second-line standard-of-care for patients with platinum-sensitive disease to improve progression-free survival as compared to those treated with standard-of-care and placebo.
Improvements in overall survival, objective tumor responses and the number of patients exhibiting longer second remission periods as compared to their primary remission are the secondary endpoints.
Farletuzumab is a humanized monoclonal antibody that targets folate receptor alpha (FRA), which is expressed on the majority of non-mucinous epithelial ovarian cancers as well as a subset of other carcinomas.