Organon, the healthcare business unit of Akzo Nobel which is being acquired by Schering-Plough, is to discontinue a trial of its hormone replacement therapy Livial in breast cancer patients which was originally intended to last until the end of the year.
The firm said that the LIBERATE trial will close by the end of July 2007 instead of in December, following advice from the study's Data & Safety Monitoring Board (DSMB) and Advisory Board. They stated that its primary objective, of showing an equivalent effect of Livial (tibolone) and placebo in breast cancer recurrence, would not be reached over the planned duration of the study. The DSMB also found that there was a trend for an excess of breast cancer recurrences in the group of women randomised to receive Livial.
Organon noted that for women with a history of breast cancer now suffering from menopausal symptoms, no hormonal therapy option is available “while the medical need clearly exists,” and added that the firm, plus “the LIBERATE Advisory Board and investigators are disappointed that also Livial does not offer an appropriate treatment for symptoms relief in this vulnerable patient group.” The Netherlands-based firm also said that
patients on the LIBERATE trial are not “representative of healthy women taking Livial and that women with known, past or suspected breast cancer are absolutely contraindicated to its use.” The trial was started in May 2002 and had enrolled more than 3000 patients. The results will be published as soon as the final data are analysed.
The premature end to the trial is the second clinical disappointment that Organon has suffered with Livial recently. Last February, it terminated the LIFT study, which was investigating the effect of tibolone on new vertebral fractures in elderly osteoporosis patients, after an interim analysis showed that the agent increased the incidence of stroke.
Tibolone has been available all over the world for nearly 20 years but not in the USA. Last June, the Food and Drug Administration deemed it non-approvable and Organon withdrew its application there.