Preliminary Results for New Halaven Breast Cancer Indication Announced
(ChemotherapyAdvisor) – Pharmaceutical company Eisai (Tokyo, Japan) announced in a July 10 press release that it has preliminary results of a phase 3 study (Study 301) comparing Halaven® (eribulin mesylate) vs capecitabine in locally advanced or metastatic breast cancer patients in whom prior treatment with both an anthracycline and taxane has failed.
Patients (N=1,102) enrolled in this open-label, randomized, 2-parallel-arm, multicenter study were randomized to receive either Halaven 1.4mg/m2/day (administered intravenously on days 1 and 8, every 21 days) or capecitabine 2.5g/m2/day (administered orally on days 1 to 14, every 21 days) in accordance with their HER2 status.
“The trial did not meet the pre-specified criteria for either of the co-primary end points of overall survival (OS) and progression-free survival (PFS),” the company wrote. “The study did show, however, a trend toward improved OS for patients who received Halaven compared with capecitabine, but the improvement was not statistically significant. No difference was seen in PFS. Furthermore, data showed that the safety profile of Halaven was consistent with that reported in previous clinical studies.”
According to the press release, the company is currently conducting a detailed analysis of these preliminary data, including the secondary end points and subgroup analyses pre-specified in the study protocol, and will work closely with the health authorities towards potential regulatory filing.
Halaven, a non-taxane, microtubule dynamics inhibitor with a novel mechanism of action, is currently approved for the treatment of breast cancer in 37 countries worldwide, including Japan, the United States, European Union (EU) member states and Singapore.