publication date: Mar. 31, 2015
Phase III Halaven Trial Shows Extended OS over Dacarbazine
A phase III trial of Halaven (eribulin) in patients with soft tissue sarcoma demonstrated a statistically significant extension in overall survival over the comparator treatment dacarbazine, the primary endpoint of the study. No other systemic treatment for locally advanced or metastatic soft tissue sarcoma has been reported to extend overall survival in a phase III study, according to Halaven’s sponsor, Eisai.
Eribulin, as a single agent, previously demonstrated overall survival benefit in advanced breast cancer, following two prior regimens in the advanced setting. Eisai plans to present these data at an upcoming peer review forum as soon as possible.
First in the halichondrin class, Halaven is a microtubule dynamics inhibitor with a novel mechanism of action. Structurally, Halaven is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Halaven is currently indicated for the treatment of advanced breast cancer in 60 countries.
The clinical trial, Study 309, was a randomized, open-label multicenter phase III study that evaluated the efficacy and safety of Halaven in 452 adult patients. Treatment was administered on days one and eight of a 21-day cycle versus dacarbazine to patients with one of two subtypes: adipocytic or leiomyosarcoma locally advanced or relapsed and metastatic soft tissue sarcoma who showed disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen.
Additional endpoints in the study included progression-free survival and quality of life. In this study, the most common adverse events observed were neutropenia, fatigue, nausea, alopecia and constipation, which is consistent with the known profile of Halaven.
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