Eisai’s ovarian cancer drug misses preliminary goal in phase 3
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.
Eisai’s pivotal hopes for ovarian cancer drug dashed by PhIII flop (Fierce Biotech)
Eisai misses goal in Phase III trial (Triangle Business Journal)
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.