YONDELIS® (trabectedin) Study Design

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.

Reference:

  1. YONDELIS® (trabectedin) [package insert]. Horsham, PA: Janssen Products, LP; 2017.