Yondelis trabectedin: Updated Phase III data

Updated data from the open-label, international Phase III SAR3007 trial in 577 patients with advanced liposarcoma or leiomyosarcoma who were previously treated with an anthracycline and >=1 additional chemotherapy regimen showed that 1.5 mg/m 2 IV Yondelis every 3 weeks led to a median OS, the primary endpoint, of 13.7 months at a median follow-up of 21 months vs. 13.1 months for 1 g/m 2 IV dacarbazine every 3 weeks (HR=0.93, 95% I: 0.75, 1.15, p=0.492). The median time to initiation of subsequent therapy was 6.8 months in the Yondelis arm vs. 3.5 months in the dacarbazine arm (HR=0.53, p<0.0001). Data were presented at the European Cancer Congress in Vienna. Interim data from the trial showed that Yondelis did not improve median OS vs. dacarbazine (see BioCentury, June 22). ...