YONDELIS® (trabectedin) Efficacy

YONDELIS® significantly improved Progression-Free Survival (PFS)

YONDELIS® is the first FDA-approved treatment for liposarcoma and leiomyosarcoma studied against an active comparator in a phase 3 trial.1

 

YONDELIS® improved median PFS* vs dacarbazine:

4.2 months | YONDELIS®

1.5 months | dacarbazine

(HR=0.55; 95% CI: 0.44, 0.70; P<0.001)1

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

 

*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.

CI = confidence interval.

HR = hazard ratio.

PFS = the time from randomization to the occurrence of disease progression or death, whichever occurred first.3

YONDELIS® demonstrated activity in both leiomyosarcoma and liposarcoma2

PFS outcomes by subtype2

PFS outcomes by subtype

§n values represent the number of patients in each subgroup.

 

Additional efficacy data

Overall Survivalll (median)1:

13.7 months for YONDELIS®

VS

13.1 months for dacarbazine

(HR=0.93; 95% CI: 0.75, 1.15; P=0.49)

Objective Response Rate
(CR+PR)1:

7% (23/345) for YONDELIS®
(95% CI: 4.3, 9.8)

VS

6% (10/173) for dacarbazine
(95% CI: 2.8, 10.4)

Duration of Response (CR+PR) (median)1:

6.9 months for YONDELIS®
(95% CI: 4.5, 7.6)

VS

4.2 months for dacarbazine
(95% CI: 2.9, NE)

 

Overall survival = the time between randomization and death from any cause.3

Objective response rate = percentage of patients achieving complete response or partial response.3

Duration of response = duration of response for patients with complete response or partial response.

NE = not estimable.

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

P value is based on unstratified log-rank test.

llBased on 384 patients randomized to the YONDELIS® arm and 193 patients randomized to dacarbazine.

Fisher’s exact CI.

 

Continue until disease progression or unacceptable toxicity

 

 

References:

  1. YONDELIS® (trabectedin) [package insert]. Horsham, PA: Janssen Products, LP; 2017.
  2. Demetri GD, von Mehren M, Jones RL, et al. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol. 2016;34(8):786-793.
  3. Chmielowski B, Federman N, Tap WD. Clinical trial end points for assessing efficacy of novel therapies for soft-tissue sarcomas. Expert Rev Anticancer Ther. 2012;12(9):1217-1228.