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Efficacy

YONDELIS® significantly improved progression-free survival (PFS)*vs dacarbazine in a clinical trial.

YONDELIS® resulted in a 45% reduction in the risk of disease progression or death (PFS) compared with dacarbazine

YONDELIS® improved median PFS vs dacarbazine: 4.2 months with YONDELIS® vs 1.5 months for dacarbazine (HR=0.55; 95% CI: 0.44, 0.70; P<0.001)

YONDELIS® provided a significant reduction in the risk of disease progression or death vs dacarbazine
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*

An exploratory analysis of independent radiology committee—determined PFS, in a subgroup consisting of approximately 60% of the total population, provided similar results to the investigator-determined PFS.

Hazard ratio (HR) is estimated using Cox proportional hazards model with treatment group as the only covariate.

P value is based on unstratified log-rank test.

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Additional data

YONDELIS® (trabectedin) median overall survival rate and duration of response

Objective Response Rate§ll

The ORR was 7% for YONDELIS® (95% Cl: 4.3, 9.8) vs 6% for dacarbazine (95 Cl: 2.8, 10.4)

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Objective Response Rate§ll

The ORR was 7% for YONDELIS® (95% Cl: 4.3, 9.8) vs 6% for dacarbazine (95 Cl: 2.8, 10.4)

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Objective Response Rate§ll

The ORR was 7% for YONDELIS® (95% Cl: 4.3, 9.8) vs 6% for dacarbazine (95 Cl: 2.8, 10.4)

Hazard ratio (HR) is estimated using Cox proportional hazards model with treatment group as the only covariate.

P value is based on unstratified log-rank test.

§

Objective response rate (ORR) is defined as the proportion of subjects who achieved a complete response or partial response as best response.

ll

ORR 95% CI is based on Fisher′s exact CI.

Study Design:

A phase 3 randomized, open-label, active-controlled, multicenter trial of patients with unresectable or metastatic leiomyosarcoma or liposarcoma previously treated with at least an anthracycline- and ifosfamide-containing regimen or an anthracycline-containing regimen and 1 additional cytotoxic chemotherapy regimen. A total of 518 patients were randomized (2:1) to receive either YONDELIS® (1.5 mg/m2 by 24-hour intravenous infusion once every 3 weeks, n=345) or dacarbazine (1 g/m2 once every 3 weeks, n=173). The median patient age was 56 years (range 17 years to 81 years); 73% had leiomyosarcomas, 27% liposarcomas, and all patients had an Eastern Cooperative Oncology Group (ECOG) score of ≤1.

The efficacy measures were progression-free survival (PFS), overall survival, objective response rate (ORR), and duration of response (DOR). The majority of patients in both treatment groups had received ≥2 prior lines of chemotherapy.

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results in clinical trials

INDICATION

YONDELIS® (trabectedin) is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

 

Important Safety Information

 

Indication

INDICATION

YONDELIS® (trabectedin) is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

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