Halaven fails Phase III study in Non Small Cell Lung Cancer - Eisai
Eisai announced 8 August 2014 top-line results of the investigational Phase III study (Study 302) of its in-house developed anticancer agent halaven (eribulin mesylate) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) that has progressed following two or more prior treatment regimens. Study 302 was a global, multicenter, randomized, open-label Phase III trial comparing the efficacy and safety of eribulin with a single treatment of physician�s choice (TPC) consisting of either docetaxel, pemetrexed, gemcitabine or vinorelbine in 540 patients with advanced NSCLC and disease progression following at least two prior regimens for advanced disease, which included a platinum-based regimen.
The preliminary analysis of the study showed that Study 302 did not meet its primary endpoint of improving overall survival (OS); the median OS in both arms was 9.5 months (Hazard Ratio 1.16; p=0.1343). The preliminary safety analysis showed that the most common adverse reactions in the eribulin arm were decreased appetite, neutropenia, alopecia, nausea and fatigue, which were consistent with the known side-effect profile of eribulin.
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