The efficacy and safety of HALAVEN were evaluated in an open-label, randomized (1:1), multicenter, active-controlled trial. Eligible patients were required to have unresectable, locally advanced, or metastatic liposarcoma or leiomyosarcoma, at least 2 prior systemic chemotherapies (one of which must have included an anthracycline), and disease progression within 6 months of the most recent chemotherapy regimen. Patients were randomized to HALAVEN 1.4 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle or to dacarbazine at a dose of 850 mg/m2, 1,000 mg/m2, or 1,200 mg/m2 administered intravenously every 21 days (dacarbazine dose was selected by the investigator prior to randomization). Treatment continued until disease progression or unacceptable toxicity. Randomization was stratified by histology (liposarcoma or leiomyosarcoma), number of prior therapies (2 vs >2), and geographic region. The most common (>40%) prior systemic chemotherapies were doxorubicin (90%), ifosfamide (62%), gemcitabine (59%), trabectedin (50%), and docetaxel (48%).2
OS=overall survival; CI=confidence interval.
There was no evidence of efficacy of HALAVEN in patients with advanced or metastatic leiomyosarcoma in this trial2
Patients in the HALAVEN arm with liposarcoma had a 49% reduction in relative risk of death vs control group2,3
HR=hazard ratio; PFS=progression-free survival.
aEfficacy data from 1 study site enrolling 6 patients were excluded.
bAll patients=liposarcoma and leiomyosarcoma.
References: 1. Schöffski P, Chawla S, Maki RG, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016;387(10028):1629-1637. 2. HALAVEN [package insert]. Nutley, NJ: Eisai Inc. 3. NCI dictionary of cancer terms. National Cancer Institute Web site. http://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=618612. Accessed January 15, 2016.