This site is intended for healthcare professionals
Drug news

Halaven fails Phase III study in Non Small Cell Lung Cancer - Eisai

Read time: 1 mins
Last updated:11th Aug 2014
Published:11th Aug 2014
Source: Pharmawand

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´┐Żs 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.

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.