YONDELIS® was studied in a phase 3 randomized, open-label, active-controlled, multicenter trial of patients with unresectable, locally advanced or metastatic leiomyosarcomas (73%) or liposarcomas (27%).1
N=518
- Median age was 56 years (range: 17 years to 81 years)
- All patients had an ECOG score of ≤1
- Previously treated with an anthracycline- and ifosfamide-containing regimen or an anthracycline-containing regimen and 1 additional cytotoxic chemotherapy regimen
- The majority had received ≥2 prior lines of chemotherapy
2:1 RANDOMIZATION
YONDELIS®
(n=345)
(1.5 mg/m2 by 24-hour IV infusion once every 3 weeks)
Dacarbazine
(n=173)
(1,000 mg/m2 IV once every 3 weeks)
Efficacy Measures
Progression-free survival (PFS)
Overall survival (OS)
Objective response rate (ORR)
Duration of response (DOR)
ECOG = Eastern Cooperative Oncology Group.
IV = intravenous.
See the safety results in clinical trials.