Halaven eribulin mesylate: Preliminary Phase III data
Preliminary data from the open-label, international Phase III Study 301 trial in 1,102 patients showed that Halaven missed the co-primary endpoints of OS and PFS vs. Xeloda capecitabine. Details were not disclosed. The trial enrolled women with locally advanced or metastatic breast cancer who were previously treated with anthracyclines and taxanes either in the adjuvant setting or for locally advanced or metastatic disease. Patients received up to 3 prior chemotherapy regimens and 0-2 prior regimens for advanced disease. Patients received 1.4 mg/m 2 IV Halaven on days 1 and 8 of a 21-day cycle or 2.5 g/m 2 Xeloda on days 1-14 of a 21-day cycle. Eisai said the data do not affect Halaven's approved indication to treat locally advanced or metastatic breast cancer in patients who have progressed after >=2 chemotherapy regimens. ...