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news.Ipsen has decided to terminate the development of Irosustat in monotherapy on the basis of futility analysis from an European Phase II clinical study which showed that the drug was not effective when used in monotherapy in endometrial cancer.
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Irosustat is an orally available irreversible steroid sulfatase (STS) inhibitor.
According to futility analysis, the trial will not meet the primary endpoint and the superiority will not be demonstrated with Irosustat versus megestrol acetate in terms of progression free survival (PFS).
The primary endpoint for the study was the proportion of patients who have neither progressed nor died after 6 months of treatment with Irosustat.
The company has now agreed to investigate Irosustat (BN 83495) in conjunction with other hormonal therapies in hormone-dependent cancers.