YONDELIS® is the first FDA-approved treatment for liposarcoma and leiomyosarcoma studied against an active comparator in a phase 3 trial.1
View the Study Design.
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
*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
View the Study Design.
PFS outcomes by subtype2
§n values represent the number of patients in each subgroup.
13.7 months for YONDELIS®
VS
13.1 months for dacarbazine
(HR†=0.93; 95% CI: 0.75, 1.15; P=0.49‡)
7% (23/345) for YONDELIS®
(95% CI¶: 4.3, 9.8)
VS
6% (10/173) for dacarbazine
(95% CI¶: 2.8, 10.4)
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.
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