A randomized, double-blind, placebo-controlled phase II study of the efficacy and safety of farletuzumab (MORAb-003) in combination with weekly paclitaxel in subjects with platinum-resistant or refractory relapsed ovarian cancer.

TPS255 Background: Farletuzumab (MORAb-003) is a humanized monoclonal antibody that binds to the folate receptor alpha (FRA) which is overexpressed in most epithelial ovarian cancers (EOC), but largely absent on normal tissue. The expression of FRA is known to relate to the malignant potential of the cancer. Farletuzumab has been shown to inhibit phosphorylation of proteins by the Lyn kinase (a member of the src family of kinases). It inhibits tumor growth in preclinical xenograft models of ovarian cancer, in addition to being active in antibody-dependent cellular cytotoxicity (ADCC) assays (Ebel W et al. Cancer Immun 2007; 7:6). It showed signs of efficacy as a single agent in a phase I study in subjects with advanced platinum refractory/resistant EOC (Bell-McGuinn KM et al. J Clin Oncol 2008;26 (15S):5517). In this phase I study, as well as in a subsequent phase II study (Armstrong DK. et al. 2009 ECCO and ESMO Congress, Abstract 08000), farletuzumab demonstrated a favorable safety profile. Weekly low d...