Clinical Data
This approval was based on the results from a multicenter, open-label, randomized Phase III study (Study 309) comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced or recurrent and metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen.

Halaven demonstrated a statistically significant extension in the study's primary endpoint of OS over the comparator treatment dacarbazine (Halaven median OS: 13.5 months vs dacarbazine median OS: 11.5 months; Hazard Ratio (HR) 0.768 [95% CI=0.618-0.954], p=0.017).1
For patients with liposarcoma, Halaven demonstrated a significant improvement in OS over dacarbazine (Halaven, n=71, median OS: 15.6 months vs dacarbazine, n=72, median OS: 8.4 months; HR 0.51 [95% CI=0.35-0.75]).2 Additionally, in the study's secondary endpoint of progression-free survival (PFS), patients treated with Halaven experienced an improvement in PFS over dacarbazine (Halaven median PFS: 2.9 months vs dacarbazine median PFS: 1.7 months; HR 0.52 [95% CI=0.35-0.78]).2

The most common adverse reactions (incidence greater than or equal to 25%) in study patients with liposarcoma and leiomyosarcoma treated with Halaven were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain and pyrexia, which was consistent with the known side-effect profile of Halaven.2 The most common (incidence greater than or equal to 5%) Grade 3-4 laboratory abnormalities reported in patients receiving Halaven were neutropenia, hypokalemia, and hypocalcemia. The most common serious adverse reactions reported in patients receiving Halaven were neutropenia (4.9%) and pyrexia (4.5%).