Eisai’s ovarian cancer drug misses preliminary goal in phase 3

Hannah Blake

pharmaphorum

Eisai has announced poor preliminary results of its global phase 3 clinical trials for its ovarian cancer drug, farletuzumab (MORAb-003). The Japanese pharmaceutical company was evaluating the investigational compound under development at its US subsidiary, Morphotek Inc, in patients with platinum-sensitive epithelial ovarian cancer in first relapse.

Preliminary results showed that the trial didn’t meet the primary endpoint, which were pre-specified statistical criteria for significant progression-free survival (PFS). However, post hoc exploratory analysis showed a trend towards improved PDS in some patient subsets, so further analysis will continue.

The phase 3 clinical study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparative study of 1,100 patients with platinum-sensitive epithelial ovarian cancer in first relapse. The patients received standard-of-care therapy (carboplatin and a taxane) in combination with doses of either 1.25 mg/kg of farletuzumab, 2.5 mg/kg of farletuzumab, or placebo.

After further analysis of these clinical results, Eisai will determine a new development strategy based on discussion with external experts and the relevant health authorities.

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