Background: Ovarian cancer is the leading cause of death among women with gynecologic malignancies in North America. Despite advances in treatment, only 15%-30% of patients survive long term, underscoring the need for more effective regimens. Folate receptor ≤ (FRα) is highly expressed on all epithelial ovarian cancer (EOC) cells but largely absent from normal tissue. This study examines the efficacy and safety of farletuzumab, a monoclonal antibody that binds FRα, when combined with standard chemotherapy, in platinum-sensitive subjects with ovarian cancer after first relapse. Methods: This phase 3, randomized, double-blind, placebo-controlled trial is ongoing at 375 sites globally. Eligible subjects are β18 years of age, with a histologically confirmed diagnosis of non-mucinous EOC, including primary peritoneal and fallopian tube malignancies. Subjects must have undergone debulking surgery and achieved an objective response lasting 6-24 months following first-line platinum and taxane chemotherapy, followed by relapse confirmed by computed tomography or magnetic resonance imaging. Approximately 1080 subjects will be randomized to receive weekly intravenous farletuzumab (1.25 mg/kg or 2.5 mg/kg) or placebo, plus standard carboplatin (area under the curve [AUC] 5-6) and taxane (paclitaxel at 175 mg/m2 or docetaxel at 75 mg/m2) every 3 weeks for 6 cycles. Maintenance treatment follows, with weekly single-agent farletuzumab or placebo administered until disease progression. The primary end point is progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST). Secondary outcomes are overall survival, CA-125-defined PFS (based on Rustin criteria) and serologic response, best objective response and time to response, duration of first vs current remission (by RECIST), subject-reported quality of life, and resource utilization (hospitalizations, unscheduled office visits, and admissions to hospice or nursing home). Molecular markers are being sought that may be predictive of response to farletuzumab. Pharmacokinetic analysis is performed to assess interactions between agents. Safety will be evaluated by review of physical assessments, laboratory data, and adverse events; review is overseen by an independent data monitoring committee. As of November 7, 2011, 957 (of 1080 planned) subjects have enrolled in the study. The last subject will likely be enrolled by March 2012.

Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 1750. doi:1538-7445.AM2012-1750