Yondelis trabectedin: Interim Phase III data

Interim data from the open-label, international Phase III SAR3007 trial in 518 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 did not improve median OS vs. 1 g/m 2 IV dacarbazine every 3 weeks (12.4 vs. 12.9 months, HR=0.87, 95% CI: 0.644, 1.181 p=0.3741). Yondelis did significantly improve median PFS vs. dacarbazine (4.2 vs. 1.5 months, HR=0.55, 95% CI: 0.436, 0.696, p<0.0001). Additionally, Yondelis led to an ORR of 9.9% and a clinical benefit rate (CBR) of 34.2% vs. 6.9% and 18.5%, respectively, for dacarbazine (p=0.3269 and p=0.0002, respectively). Median duration of response was 6.47 months for Yondelis vs. 4.17 months for dacarbazine (HR=0.47, 95% CI: 0.168, 1.318, p=0.1415). Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...