Eisai cancer drug fails
pharmafile | January 14, 2013 | News story | Research and Development, Sales and Marketing | Cancer, Eisai, Morphotek, farletuzumab
Eisai’s investigational oncology treatment farletuzumab has failed to reach its primary endpoint in a late-stage trial.
Farletuzumab (MORAb-003) did not meet the pre-specified statistical criteria for significant progression-free survival (PFS) in patients with platinum-sensitive epithelial ovarian cancer in first relapse.
The global Phase III trial, Study FAR 131, saw patients receiving standard of care (carboplatin and a taxane) plus doses of either 1.25 mg/kg or 2.5 mg/kg of farletuzumab, or placebo.
There are an estimated 140,000 deaths from ovarian cancer worldwide each year, and around 90% of tumours are carcinomas which are often not diagnosed until they are at an advanced stage.
While surgery and chemotherapy works for many patients, relapse remains common, Eisai says.
While the study of 1,100 patients did not achieve what it set out to, Eisai is pinning hopes on the fact that a post hoc analysis of the monoclonal antibody showed a trend towards improved PFS in some patient subsets.
Further analysis is ongoing, the manufacturer says, adding that safety appears to be in line with what is expected from chemotherapy agents.
The drug is being developed at Eisai’s US subsidiary Morphotek and Eisai insists it remains committed to seeing what its clinical benefits might be.
The humanized, IgG1 monoclonal antibody binds to the folate receptor-alpha (FRA), a folate-binding protein expressed on ovarian and several other epithelial cancer cells. Some immune-mediated events were observed in the trial with farletuzumab, the company adds.
“After further analysis of these clinical results, the company will determine a new development strategy based on discussion with external experts and the relevant health authorities,” the manufacturer concludes.
Adam Hill
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