IDMC recommends Ph III Yondelis trial continues

Spain's PharmaMar says that the planned Independent Data Monitoring Committee review of a Phase III trial (OVA-301) of Yondelis (trabectedin) in ovarian cancer has recommended that the present pivotal clinical evaluation should continue without modification.

The Madrid-based subsidiary of the Zeltia group noted that the IDMC can recommend that a study be stopped, suspended or amended if it determines that a trial is not meeting necessary safety and efficacy requirements. In the case of OVA-301, this recommendation means that the trial is progressing "positively as expected," stated PharmaMar, which is developing the cell-cyle disruptor together with US health care major Johnson & Johnson.

The pivotal Phase III multi-national study will enrol a total of 650 patients. The firm noted that the accrual halfway point in the study (325 patients) has occurred and recruitment is on target for completion in the first half of 2007. The trial is comparing treatment with Schering-Plough's Caelyx (doxorubicin HCl liposome injection), marketed as Doxil in the USA, to a combination of that drug with Yondelis in relapsed ovarian cancer patients receiving standard first-line chemotherapy. The primary objective is to test the hypothesis that this combination therapy improves progression-free and overall survival in women with relapsed ovarian cancer.