Dutch-based drug firm Organon is to discontinue a trial of itshormone replacement therapy tibolone (Livial®) in breast cancerpatients which was originally intended to last until the end of theyear.
The firm said the LIBERATE trial will close by theend of July 2007 instead of in December, following advice from thestudy’s data and safety monitoring and advisory boards. The firm saidits primary objective – to show an equivalent effect of tibolone andplacebo in breast cancer recurrence – would not be reached over theplanned duration of the study. The drug safety board also found a trendtowards an excess of breast-cancer recurrences in the group of womenrandomised to receive tibolone.
Organon noted that forwomen with a history of breast cancer now suffering from menopausalsymptoms, no hormonal therapy option is available, “while the medicalneed clearly exists”, and added that the firm, plus “the LIBERATEadvisory board and investigators are disappointed that also Livial doesnot offer an appropriate treatment for symptom relief in thisvulnerable patient group”.
The firm also said patients onthe LIBERATE trial were not “representative of healthy women takingLivial and that women with known, past or suspected breast cancer areabsolutely contraindicated to its use”. The trial began in May 2002 andhad enrolled more than 3,000 patients. The results will be published assoon as the final data are analysed.
The premature end tothe trial is the second clinical disappointment Organon has sufferedwith Livial recently. Last February it terminated the LIFT study, whichwas investigating the effect of tibolone on new vertebral fractures inelderly osteoporosis patients, after an interim analysis showed theagent increased the incidence of stroke.
Tibolone has beenavailable worldwide, except for the USA, for nearly 20 years. In June2006 the FDA deemed it nonapprovable and Organon withdrew itsapplication in the USA.