Phase III trial of MORAb 003 (Morphotek/Eisai) for Ovarian Cancer fails to meet primary endpoint
Top-line results from a Phase III study of MORAb 003 (farletuzumab), from Morphotek/Eisai, in combination with carboplatin and a taxane in patients with platinum-sensitive epithelial Ovarian Cancer in first relapse did not meet the study's primary endpoint of progression-free survival (PFS). In the double-blind, placebo-controlled FAR 131 study, 1,100 patients were enrolled to receive standard-of-care (carboplatin and a taxane [paclitaxel or docetaxel]) chemotherapy and were randomized to three parallel groups to receive one of two different dose levels of farletuzumab or placebo.
The post hoc exploratory analysis showed, however, a trend toward improved PFS in some patient subsets and further analysis is ongoing. The preliminary safety analysis indicated that the most commonly reported adverse events were those known to be associated with the study chemotherapy agents. Additionally, some immune-mediated events were observed with farletuzumab.
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